Analysis on blood samples from the psoriasis HeROPA-trial revealed statistically
significant effects of HRO350 versus placebo on Systemic Immune-inflammation
Index (SII) in patients with mild-to-moderate psoriasis. Significantly more
patients treated with HRO350 achieved a ? 25% reduction in a systemic
inflammatory marker at both 26 weeks and 1 year compared to placebo. Among
patients with lower baseline systemic inflammation, this reduction was
accompanied by statistically significant improvements in psoriasis skin symptoms
and quality of life, shown through achievement of sPGA0/1 and DLQI0/1 in the
HRO350 group after 1 year.
The results show that patient screening based on baseline SII in mild-to
-moderate psoriasis may reduce the inherent uncertainty in the patient target
group for HRO350 in further development phase. Inflammation plays a key role in
psoriasis and can be measured through biomarkers. Systemic inflammation measured
in blood provides a distinct perspective on disease severity compared to skin
symptoms. These findings on the impact of HRO350 on inflammation aligns with in
vitro cellular data indicating involvement of HRO350 in resolution of
inflammation.
"These new findings showing the potential of HRO350 in reducing inflammation are
of significant value for Arctic Bioscience. The data strengthens a further
development within mild-to-moderate psoriasis, as well as the potential of
general effects on inflammation which may strengthen our HRO350-asset. The
findings from these analyses will also be important as we now enter commercial
dialogues with potential partners", says Christer Valderhaug, CEO.
The Systemic Immune-inflammation Index (SII) is a biomarker which reflects
systemic inflammation and immune status. SII has been found to correlate with
psoriasis severity, risk of disease activation, and decreases with effective
systemic therapy.
"Psoriasis is an inflammatory skin disease, which is associated with premature
cardiovascular disease. SII is a measure of systemic inflammation, which is an
independent risk factor for cardiovascular disease. A high SII is associated
with treatment resistance to even highly effective biologic drugs. For the
patients with a lower amount of inflammation in the HeROPA trial, the drug is
working. The treatment shows a difference to placebo in patients with lower
inflammation - and it lowers inflammation in all patients, which may also be
beneficial for long term cardiovascular health", says Professor Brian Kirby,
Ireland, who has served on the Data Monitoring Committee for the HeROPA trial.
The HeROPA study is a phase 2b study investigating efficacy and safety of HRO350
in mild-to-moderate psoriasis and included over 500 patients in five countries.
HRO350 was well tolerated throughout the study, with no safety concerns or drug
-related serious adverse events reported. All the patients in the HeROPA trial
had mild-to-moderate psoriasis as assessed by their skin symptoms (PASI < 10).
However, a significant portion of the patients had an SII at start that could be
associated with more severe inflammation.
Psoriasis is a chronic, immune-mediated inflammatory disease. If untreated,
subclinical inflammation may increase patients' risks for disease progression to
severe psoriasis. Early treatment intervention for psoriasis may help reducing
risk of developing multiple comorbidities, including psoriatic arthritis.
Arctic Bioscience strongly believe there is a major market potential for HRO350
in mild-to-moderate psoriasis and will seek partnerships for further
development.
Significant effects on systemic inflammation, particularly among patients with
lower baseline systemic inflammation, suggest platform potential for HRO350. The
observed anti-inflammatory activity positions HRO350 as a potential treatment
option for inflammatory conditions.
Please see attachment for more details and results from the analyses conducted.
This information is subject to the disclosure requirements pursuant to section 5
-12 of the Norwegian Securities Trading Act.
For more information, please contact:
Christer L. Valderhaug
CEO
Phone: +47 920 84 601
E-mail: christer@arctic-bioscience.com
About Arctic Bioscience
Arctic Bioscience is a biotech company developing and commercializing
pharmaceutical and nutraceutical products based on unique bioactive marine
compounds.
The company is developing HRO350 - a novel oral drug candidate. HRO350 is being
developed for treatment of patients with mild-to-moderate psoriasis. This is a
large patient group in need of new effective medicines with beneficial safety
profile.
Nutraceuticals from Arctic Bioscience are sold globally as bulk ingredients as
well as finished goods under the ROMEGA® brand.
Arctic Bioscience is led by a highly skilled team of talents with diverse and
highly relevant background.