<SEC-DOCUMENT>0001654954-26-003013.txt : 20260331
<SEC-HEADER>0001654954-26-003013.hdr.sgml : 20260331
<ACCEPTANCE-DATETIME>20260331074812
ACCESSION NUMBER:		0001654954-26-003013
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20260331
FILED AS OF DATE:		20260331
DATE AS OF CHANGE:		20260331

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			ASTRAZENECA PLC
		CENTRAL INDEX KEY:			0000901832
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		ORGANIZATION NAME:           	03 Life Sciences
		EIN:				000000000
		STATE OF INCORPORATION:			X0
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-11960
		FILM NUMBER:		26817060

	BUSINESS ADDRESS:	
		ADDRESS IS A NON US LOCATION: 	YES
		STREET 1:		1 FRANCIS CRICK AVENUE
		STREET 2:		CAMBRIDGE BIOMEDICAL CAMPUS
		CITY:			CAMBRIDGE
		PROVINCE COUNTRY:   	X0
		ZIP:			CB2 0AA
		BUSINESS PHONE:		011 44 20 7304 5000

	MAIL ADDRESS:	
		ADDRESS IS A NON US LOCATION: 	YES
		STREET 1:		1 FRANCIS CRICK AVENUE
		STREET 2:		CAMBRIDGE BIOMEDICAL CAMPUS
		CITY:			CAMBRIDGE
		PROVINCE COUNTRY:   	X0
		ZIP:			CB2 0AA

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ZENECA GROUP PLC
		DATE OF NAME CHANGE:	19930422
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>a7230y.htm
<DESCRIPTION>EFZIMFOTASE ALFA PH3 PROGRAM SHOW POSITIVE RESULTS
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1.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
Efzimfotase alfa Ph3 program show positive results</font></div>
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&#xA0;</font></div>
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This announcement contains inside information</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
31 March 2026</font></div>
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&#xA0;</font></div>
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<font style="color: #000000; font-weight: bold; font-family: Times New Roman; font-size: 13px">
<font style="font-size: 16px">Efzimfotase&#xA0;alfa&#xA0;demonstrated positive
results from global Phase III clinical programme&#xA0;in
hypophosphatasia</font></font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
MULBERRY randomised, placebo-controlled trial showed efzimfotase
alfa demonstrated statistically significant and clinically
meaningful improvement in bone health in treatment-na&#x25CF;ve
paediatric patients</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
CHESTNUT randomised, open-label, active-controlled trial
demonstrated safety and tolerability of efzimfotase alfa in
paediatric patients previously treated with Strensiq with
maintenance of therapeutic benefit</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
HICKORY randomised, placebo-controlled trial showed numerical
improvement but did not achieve statistical significance in the
primary endpoint in treatment-na&#x25CF;ve adolescents and adults;
results indicate clinically meaningful benefit in a combination of
prespecified subgroups of adolescents and adults with
paediatric-onset HPP</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
The efzimfotase alfa&#xA0;(ALXN1850) Phase III clinical programme,
designed to study a broad hypophosphatasia (HPP) patient
population, demonstrated positive results.&#xA0; The global
clinical programme, which included two randomised,
placebo-controlled trials and one randomised, open-label,
active-controlled paediatric switch trial, enrolled 196 patients
spanning children, adolescents and adults with either
paediatric-onset or adult-onset HPP across 22
countries.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Addressing unmet needs for people living with HPP</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Efzimfotase alfa is an investigational enzyme replacement therapy
designed to offer lower injection volume, less frequent dosing
over&#xA0;</font><font style="font-style: italic; color: #000000">Strensiq</font><font style="color: #000000">&#xA0;(asfotase alfa) and close critical gaps in
care within the broader HPP patient population.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Paediatric clinical trials</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The MULBERRY Phase&#xA0;III trial in children (2 to &lt;12 years of
age) with HPP who have not been previously treated
with&#xA0;</font><font style="font-style: italic; color: #000000">Strensiq,</font><font style="color: #000000">&#xA0;showed that efzimfotase alfa met its primary
endpoint</font><font style="font-style: italic; color: #000000">.</font><font style="color: #000000">&#xA0;Results demonstrated a statistically
significant and clinically meaningful improvement in bone health
from baseline compared to placebo, as measured by Radiographic
Global Impression of Change (RGI-C) Score at week 25. In addition,
statistically significant improvement was observed in the key
secondary endpoint of change from baseline in Rickets Severity
Score (RSS) at week 25. Additional secondary endpoints measuring
physical function (Six-Minute Walk Test) and motor proficiency
(Paediatric Outcomes Data Collection Instrument or PODCI) further
supported the overall clinical benefit of efzimfotase alfa in the
paediatric population.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Positive high-level results from the CHESTNUT Phase III trial
showed that efzimfotase alfa was well-tolerated and demonstrated a
favourable safety profile in paediatric patients (2 to &lt;12 years
of age) switching from&#xA0;</font><font style="font-style: italic; color: #000000">Strensiq</font><font style="color: #000000">&#xA0;and maintained the treatment benefit
of&#xA0;</font><font style="font-style: italic; color: #000000">Strensiq</font><font style="color: #000000">&#xA0;on bone health at week 25, as measured by
secondary endpoints RGI-C and RSS.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Adolescent and adult clinical trial</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
In the HICKORY Phase&#xA0;III trial, efzimfotase alfa showed
numerical improvement but did not achieve statistical significance
in the primary endpoint of Six-Minute Walk Test (6MWT) in
adolescents and adults (12 years of age and older) with HPP who
have not been previously treated with&#xA0;</font><font style="font-style: italic; color: #000000">Strensiq</font><font style="color: #000000">, compared to placebo at week 25. This
was&#xA0;largely due to better-than-expected results observed in
the adult-onset HPP placebo group. However, treatment with
efzimfotase alfa demonstrated nominally significant improvements in
Functional Assessment of Chronic Illness Therapy-Fatigue
(FACIT-Fatigue) in the overall study population.
&#xA0;</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
In a combination of prespecified subgroups of adolescents and
adults with paediatric-onset HPP, efzimfotase alfa showed nominally
statistically significant and clinically meaningful benefits in
mobility, as measured by 6MWT, as well as key secondary endpoints
measuring physical function and pain reduction, compared to
placebo. &#xA0;&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
Initial findings from the ongoing, long-term, open-label extension
of the HICKORY trial show continued improvement in the primary and
key secondary endpoints at week 48. Participants who switched from
placebo to efzimfotase alfa after the randomised period also showed
clinically meaningful improvements across multiple efficacy
outcomes after 24 weeks of treatment.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
Efzimfotase alfa was well-tolerated and had an acceptable safety
profile across the MULBERRY, CHESTNUT and HICKORY clinical
trials.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Eric Rush, MD, Clinical Geneticist, Children&#xD5;s Mercy Hospital
Kansas, Professor of Paediatrics, University of Missouri-Kansas
City School of Medicine and lead</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">principal
investigator in the&#xA0;MULBERRY trial, said: &#xD2;The results
from the global MULBERRY clinical trial demonstrate efzimfotase
alfa&#xD5;s potential to address the underlying pathophysiology of
HPP and to prevent and reverse the substantial skeletal and
functional impacts of this lifelong rare disease. I am encouraged
by these results and the potential for this innovative,
investigational therapy to redefine care in HPP with a convenient
self-administered option taken every two
weeks.&#xD3;</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
Kathryn Dahir, MD, Director of the Programme for Metabolic Bone
Disorders at Vanderbilt Health and Associate Director for Clinical
Research Translation, Professor in the Department of Internal
Medicine, Division of Endocrinology, Diabetes and Metabolism and
lead investigator in the HICKORY trial, said: &#xD2;Findings from
the broad HICKORY registrational trial, the first to include
patients with adult-onset disease, highlight the heterogeneity of
the disease and the value of assessing a range of clinically
meaningful endpoints across diverse patient populations. The
results indicate a clinically relevant impact on mobility, physical
function, pain and fatigue, demonstrating the potential for
efzimfotase alfa to improve outcomes for patients living with this
disease.&#xD3;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Marc Dunoyer, Chief Executive Officer, Alexion, AstraZeneca Rare
Disease, said: &#xD2;The efzimfotase alfa clinical programme,
comprised of three global Phase III trials, was the first to
include patients with both paediatric- and adult-onset HPP with
heterogeneous manifestations beyond bone.</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">We
are encouraged by the improvements observed across this patient
population who exhibit a wide range of severity and clinical
characteristics. Collectively, these results support the potential
for efzimfotase alfa to transform the treatment paradigm for people
living with this rare disease.&#xD3;</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
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<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
These data will be presented at a forthcoming medical meeting and
shared with global regulatory authorities.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
<font style="text-decoration: underline">Notes</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Hypophosphatasia</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Hypophosphatasia (HPP) is a rare, chronic, inherited metabolic
disease caused by deficient activity of the enzyme alkaline
phosphatase (ALP), which is important for building healthy bones
and supporting proper muscle function.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font><font style="color: #000000">&#xA0;HPP
is characterised by defective mineralisation (the process that
hardens and strengthens bones and teeth), impaired calcium and
phosphate regulation and functional impairments, such as muscle
weakness, neurologic symptoms, generalised fatigue and pain that
can be debilitating.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1,2</font><font style="color: #000000">&#xA0;HPP
can be progressive and clinical manifestations may evolve over
time. While diagnosis rates vary&#xA0;by&#xA0;geography, there
are&#xA0;an&#xA0;estimated&#xA0;11,500 people diagnosed with
HPP&#xA0;across the&#xA0;US,&#xA0;Germany, France, UK, Italy,
Spain, Japan and China.</font><font style="font-size: 70%; vertical-align: top; color: #000000">3-6</font><font style="color: #000000">&#xA0;A
recent study from the US estimated diagnosed prevalence at 2.8 per
100,000 people.</font><font style="font-size: 70%; vertical-align: top; color: #000000">7</font><font style="color: #000000">&#xA0;HPP
affects people of all ages, with approximately 80% of people living
with HPP being adults.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1,2,7</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
MULBERRY</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
MULBERRY is a global Phase III randomised, double-blind,
placebo-controlled, multicentre trial evaluating the efficacy and
safety of efzimfotase alfa (ALXN1850) in paediatric patients (2 to
&lt;12 years of age) with hypophosphatasia (HPP) who have not been
previously treated with&#xA0;</font><font style="font-style: italic; color: #000000">Strensiq</font><font style="color: #000000">&#xA0;(asfotase alfa). The trial enrolled 29
patients from 14 countries across North America, South America,
Europe and Asia.</font><font style="font-size: 70%; vertical-align: top; color: #000000">8</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Patients were required to have an HPP diagnosis and the presence of
HPP-related rickets on skeletal X-rays and low serum alkaline
phosphatase (ALP) activity. Eligible patients also needed to
demonstrate either a variant in&#xA0;</font><font style="font-style: italic; color: #000000">ALPL</font><font style="color: #000000">, the gene encoding ALP, or elevated levels of
plasma pyridoxal 5'-phosphate (PLP), a biomarker of
HPP.</font><font style="font-size: 70%; vertical-align: top; color: #000000">8</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Patients were randomised 2:1 to receive efzimfotase alfa at one of
three doses based on predefined weight ranges or placebo, once
every two weeks via subcutaneous injection for 24 weeks. The
primary endpoint Radiographic Global Impression of Change (RGI-C)
Score was assessed at the end of the randomised evaluation period
(Day 169), along with multiple secondary endpoints measuring
skeletal health and physical function, including change from
baseline in the Rickets Severity Score (RSS), Six-Minute Walk Test
(6MWT), Bruininks-Oseretsky Test of Motor Proficiency Score (BOT-2)
and Peabody Developmental Motor Scales Score
(PDMS-3).</font><font style="font-size: 70%; vertical-align: top; color: #000000">8</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Patients who completed the randomised evaluation period were
eligible to continue into an open-label extension period evaluating
the safety and efficacy of efzimfotase alfa, which is
ongoing.</font><font style="font-size: 70%; vertical-align: top; color: #000000">8</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
CHESTNUT</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
CHESTNUT is a global Phase III randomised, open-label,
active-controlled, multicentre trial evaluating the safety and
tolerability of efzimfotase alfa in paediatric patients (2 to
&lt;12 years of age) with hypophosphatasia (HPP) who have been
treated with 6 mg/kg per week of&#xA0;</font><font style="font-style: italic; color: #000000">Strensiq</font><font style="color: #000000">&#xA0;(asfotase alfa) for at least 6 months prior
to study initiation. The trial enrolled 43 patients from seven
countries globally.</font><font style="font-size: 70%; vertical-align: top; color: #000000">9</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Patients were required to have an HPP diagnosis and have been
treated with&#xA0;</font><font style="font-style: italic; color: #000000">Strensiq</font><font style="color: #000000">&#xA0;for at least 6 months before the start of
the trial with open growth plates confirmed by
X-ray.</font><font style="font-size: 70%; vertical-align: top; color: #000000">9</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Patients were randomised 1:1 to receive efzimfotase alfa at one of
three doses based on predefined weight ranges once every two weeks
or 6 mg/kg/week of&#xA0;</font><font style="font-style: italic; color: #000000">Strensiq</font><font style="color: #000000">&#xA0;via 3x or 6x subcutaneous injections per
week for 24 weeks. The primary endpoint is the incidence of
treatment-emergent adverse events (TEAEs) at the end of the
randomised evaluation period. Key secondary endpoints include
change from baseline in the Rickets Severity Score (RSS)
and</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">Radiographic
Global Impression of Change (RGI-C).</font><font style="font-size: 70%; vertical-align: top; color: #000000">9</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Patients who completed the randomised evaluation period were
eligible to continue into an open-label extension period evaluating
the safety and efficacy of efzimfotase alfa, which is
ongoing.</font><font style="font-size: 70%; vertical-align: top; color: #000000">9</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
HICKORY</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
HICKORY is a global Phase III randomised, double-blind,
placebo-controlled, multicentre trial evaluating the efficacy and
safety of efzimfotase alfa (ALXN1850) in adolescents (12 to &lt;18
years of age) and adults with hypophosphatasia (HPP) who have not
been previously treated with&#xA0;</font><font style="font-style: italic; color: #000000">Strensiq</font><font style="color: #000000">&#xA0;(asfotase alfa). The trial enrolled 124
patients from 17 countries across North America, South America,
Europe, Asia and Australia.</font><font style="font-size: 70%; vertical-align: top; color: #000000">10</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Patients were required to have a HPP diagnosis and either a variant
in&#xA0;</font><font style="font-style: italic; color: #000000">ALPL</font><font style="color: #000000">, the gene encoding alkaline phosphatase (ALP), or
elevated levels of plasma pyridoxal 5'-phosphate (PLP), a biomarker
of HPP. Eligible patients needed to demonstrate low ALP levels and
two separate Six-Minute Walk Tests (6MWTs) at or below 85% of the
predicted</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">distance
adjusted for age, sex, weight and height, without a probable cause
other than HPP.</font><font style="font-size: 70%; vertical-align: top; color: #000000">10</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Patients were randomised 2:1 to receive efzimfotase alfa at one of
three doses based on predefined weight ranges or placebo, once
every two weeks via subcutaneous injection for 24 weeks. The
primary endpoint of change from baseline in 6MWT was assessed at
the end of the randomised evaluation period (Day 169), along with
multiple key secondary endpoints measuring physical function, pain,
fatigue, quality of life and safety, including change from baseline
in 30-second Sit to Stand (STS) Test Score, Lower Extremity
Functional Scale (LEFS) Score, Brief Pain Inventory Short Form
(BPI-SF) Score and Functional Assessment of Chronic Illness Therapy
&#xD0; Fatigue (FACIT-Fatigue) Score.</font><font style="font-size: 70%; vertical-align: top; color: #000000">10</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Patients who completed the randomised evaluation period were
eligible to continue into an open-label extension period evaluating
the safety and efficacy of efzimfotase alfa, which is
ongoing.</font><font style="font-size: 70%; vertical-align: top; color: #000000">10</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-weight: bold; font-family: Times New Roman; font-size: 13px">
Efzimfotase alfa (ALXN1850)</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
Efzimfotase alfa (ALXN1850) is an investigational enzyme
replacement therapy (ERT) designed to demonstrate efficacy and
safety in a broad range of patients with hypophosphatasia (HPP)
aged &#xB3;2 years, including patients without overt bone
manifestations. Efzimfotase alfa is being developed as a
subcutaneous treatment administered every two weeks to replace the
deficient alkaline phosphatase (ALP) enzyme activity that is the
underlying cause of HPP.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Alexion</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
Alexion, AstraZeneca Rare Disease, is focused on serving patients
and families affected by rare diseases and devastating conditions
through the discovery, development and delivery of life-changing
medicines. A pioneering leader in rare disease for more than three
decades, Alexion was the first to translate the complex biology of
the complement system into transformative medicines, and today it
continues to build a diversified pipeline across disease areas with
significant unmet need, using an array of innovative modalities. As
part of AstraZeneca, Alexion is continually expanding its global
geographic footprint to serve more rare disease patients around the
world. It is headquartered in Boston, US.</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development, and commercialisation of prescription medicines in
Oncology, Rare Diseases, and BioPharmaceuticals, including
Cardiovascular, Renal &amp; Metabolism, and Respiratory &amp;
Immunology. Based in Cambridge, UK, AstraZeneca&#xD5;s innovative
medicines are sold in more than 125 countries and used by millions
of patients worldwide. Please visit&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">astrazeneca.com</font><font style="color: #000000; font-size: 13px">&#xA0;and
follow the Company on social media&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">@AstraZeneca</font><font style="color: #000000; font-size: 13px">.</font></font></div>
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Contacts</font></div>
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For details on how to contact the Investor Relations Team, please
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References</font></div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">1.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Rockman-Greenberg C.
Hypophosphatasia.&#xA0;</font><font style="font-style: italic; color: #000000">Pediatr Endocrinol
Rev.</font><font style="color: #000000">&#xA0;2013;10(2):380-388.</font></font></div>
</div>
</div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">2.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Dahir KM, et al. Clinical profiles of treated and
untreated adults with hypophosphatasia in the Global HPP
Registry.&#xA0;</font><font style="font-style: italic; color: #000000">Orphanet J Rare
Dis</font><font style="color: #000000">.
2022;17(1):277.</font></font></div>
</div>
</div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">3.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Tornero C, et al. Can we identify individuals with
an ALPL variant in adults with persistent
hypophosphatasaemia?&#xA0;</font><font style="font-style: italic; color: #000000">Orphanet J Rare
Dis.</font><font style="color: #000000">&#xA0;2020;15(51).</font></font></div>
</div>
</div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">4.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Held CM, et al. Screening for hypophosphatasia:
does biochemistry lead the way?&#xA0;</font><font style="font-style: italic; color: #000000">J Pediatr Endocrinol
Metab</font><font style="color: #000000">. 2021 Sep
22;35(2):169-178.</font></font></div>
</div>
</div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">5.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Gonz&#x2021;lez-Cejudo T, et al. Mild
hypophosphatasia may be twice as prevalent as previously estimated:
an effective clinical algorithm to detect undiagnosed
cases.&#xA0;</font><font style="font-style: italic; color: #000000">Clinical Chemistry and
Laboratory Medicine (CCLM)</font><font style="color: #000000">.
2024;62(1):128-137.</font></font></div>
</div>
</div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">6.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Dahir KM, et al. Hypophosphatasia: low penetrance
of pathogenic and likely-pathogenic ALPL variants identified
through an unselected biorepository.&#xA0;</font><font style="font-style: italic; color: #000000">Journal of Bone and Mineral
Research.</font><font style="color: #000000">&#xA0;2026;
41(3):270&#xD0;281.</font></font></div>
</div>
</div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">7.</font></div>
<div style="text-align: justify; display: table-cell"><font style="color: #000000; font-family: Times New Roman; font-size: 13px">Fang
S, et al. Diagnosed prevalence of hypophosphatasia: a retrospective
analysis of electronic health records in the United States. Poster
presented at ASBMR 2025 Annual Meeting; September 5-8, 2025;
Seattle, WA.</font></div>
</div>
</div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">8.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">ClinicalTrials.gov. Phase 3 study of ALXN1850 in
treatment-na&#x25CF;ve pediatric participants with HPP (MULBERRY).
NCT Identifier: NCT06079359. Available</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF">here</font><font style="color: #000000">.
Accessed March 2026.</font></font></div>
</div>
</div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">9.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">ClinicalTrials.gov. Phase 3 study of ALXN1850 in
pediatric participants with HPP previously treated with asfotase
alfa (CHESTNUT). NCT Identifier: NCT06079372.
Available&#xA0;</font><font style="text-decoration: underline; color: #0000FF">here</font><font style="color: #000000">.
Accessed March 2026.</font></font></div>
</div>
</div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">10.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">ClinicalTrials.gov. Phase 3 study of ALXN1850
versus placebo in adolescent and adult participants with HPP who
have not previously been treated with asfotase alfa (HICKORY). NCT
Identifier: NCT06079281. Available</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF">here</font><font style="color: #000000">.
Accessed March 2026.</font></font></div>
</div>
</div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Matthew Bowden</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Company Secretary</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca PLC</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<br></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
This announcement contains information that AstraZeneca PLC is
obliged to make public pursuant to the EU Market Abuse Regulation
(596/2014) and the assimilated EU Market Abuse Regulation
(596/2014) as it forms part of the law of the United Kingdom by
operation of the European Union (Withdrawal) Act 2018. This
announcement was&#xA0;submitted&#xA0;for publication, through the
agency of the contact person(s) set out above, at 7:00 BST on 31
March 2026.&#xA0;</font></div>
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<font style="text-decoration: underline; font-family: Times New Roman; font-size: 13px">
SIGNATURES</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.</font></div>
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<div>
<table cellpadding="0" cellspacing="0" style="width: 100%; font-family: Times New Roman; font-size: 13px">
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<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
</td>
<td style="vertical-align: top; width: 29%">
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">AstraZeneca
PLC</font></div>
</td>
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</div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Date:
31 March 2026</font></div>
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<td style="vertical-align: top; width: 71%">
<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">By: /s/
Matthew Bowden</font></div>
</td>
</tr><tr>
<td style="vertical-align: top; width: 71%">
<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
</td>
<td style="vertical-align: top; width: 29%">
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Name:
Matthew Bowden</font></div>
</td>
</tr><tr>
<td style="vertical-align: top; width: 71%">
<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
</td>
<td style="vertical-align: top; width: 29%">
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Title:
Company Secretary</font></div>
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