<SEC-DOCUMENT>0001144204-17-002689.txt : 20170118
<SEC-HEADER>0001144204-17-002689.hdr.sgml : 20170118
<ACCEPTANCE-DATETIME>20170118161424
ACCESSION NUMBER:		0001144204-17-002689
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20170118
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20170118
DATE AS OF CHANGE:		20170118

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Synthetic Biologics, Inc.
		CENTRAL INDEX KEY:			0000894158
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				133808303
		STATE OF INCORPORATION:			NV
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-12584
		FILM NUMBER:		17533615

	BUSINESS ADDRESS:	
		STREET 1:		617 DETROIT STREET, SUITE 100
		CITY:			ANN ARBOR
		STATE:			MI
		ZIP:			48104
		BUSINESS PHONE:		(734) 332-7800

	MAIL ADDRESS:	
		STREET 1:		155 GIBBS STREET
		STREET 2:		SUITE 412
		CITY:			ROCKVILLE
		STATE:			MD
		ZIP:			20850

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ADEONA PHARMACEUTICALS, INC.
		DATE OF NAME CHANGE:	20081027

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	PIPEX PHARMACEUTICALS, INC.
		DATE OF NAME CHANGE:	20061214

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	SHEFFIELD PHARMACEUTICALS INC
		DATE OF NAME CHANGE:	19970730
</SEC-HEADER>
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<DESCRIPTION>FORM 8-K
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<P STYLE="margin: 0">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>SECURITIES AND EXCHANGE COMMISSION</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Washington, D.C. 20549</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>FORM 8-K</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>CURRENT REPORT</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Pursuant to Section 13 or 15(d)</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>of the Securities Exchange Act of 1934</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">Date of Report (Date of earliest event reported):
January 18, 2017</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>SYNTHETIC BIOLOGICS, INC.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">(Exact name of registrant as specified in
its charter)</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

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    <TD STYLE="width: 35%; border-bottom: black 1pt solid; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Nevada</FONT></TD>
    <TD STYLE="width: 1%; text-align: center">&nbsp;</TD>
    <TD STYLE="width: 28%; border-bottom: black 1pt solid; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">001-12584</FONT></TD>
    <TD STYLE="width: 1%; text-align: center">&nbsp;</TD>
    <TD STYLE="width: 35%; border-bottom: black 1pt solid; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">13-3808303</FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(State or other jurisdiction of <BR>
incorporation)</FONT></TD>
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD STYLE="text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(Commission File No.)</FONT></TD>
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD STYLE="text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(IRS Employer Identification No.)</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">9605 Medical Center Drive, Suite 270</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">Rockville, MD 20850</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">(Address of principal executive offices
and zip code)</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">Registrant&rsquo;s telephone number, including
area code: (301) 417-4364</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">N/A</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">(Former name or former address, if changed
since last report)</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Check the appropriate box below if the
Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 29.7pt">&nbsp;</P>

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    <TD STYLE="width: 24px"><FONT STYLE="font-family: Wingdings; font-size: 10pt"><FONT STYLE="font-family: Wingdings">&#168;</FONT></FONT></TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</FONT></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-indent: -0.25in">&nbsp;</P>

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    <TD STYLE="width: 24px"><FONT STYLE="font-family: Wingdings; font-size: 10pt"><FONT STYLE="font-family: Wingdings">&#168;</FONT></FONT></TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-indent: -0.25in">&nbsp;</P>

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    <TD STYLE="width: 24px"><FONT STYLE="font-family: Wingdings; font-size: 10pt"><FONT STYLE="font-family: Wingdings">&#168;</FONT></FONT></TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-indent: -0.25in">&nbsp;</P>

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    <TD STYLE="width: 24px"><FONT STYLE="font-family: Wingdings; font-size: 10pt"><FONT STYLE="font-family: Wingdings">&#168;</FONT></FONT></TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;&nbsp;&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Item 8.01 Other Events</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Synthetic Biologics, Inc. (the &ldquo;Company&rdquo;)
today issued a press release confirming plans to initiate a Phase 2b/3 adaptive pivotal trial for SYN-010, the Company&rsquo;s
modified-release reformulation of lovastatin lactone designed to reduce methane production by certain microorganisms (<I>M. smithii)
</I>in the gut to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C). The Company anticipates initiating
this trial during the first quarter of 2017.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In accordance with collaborative discussions
with the FDA, key components of the SYN-010 Phase 2b/3 adaptive pivotal trial will include:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 4.5pt"></TD><TD STYLE="width: 13.5pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify; padding-right: 1.8pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">A 12-week, multi-center,
double-blind, placebo-controlled, adaptive design clinical trial</FONT></TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 4.5pt"></TD><TD STYLE="width: 13.5pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify; padding-right: 0.35in"><FONT STYLE="font-family: Times New Roman, Times, Serif">A study population
of approximately 840 adult subjects diagnosed with IBS-C</FONT></TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 4.5pt"></TD><TD STYLE="width: 13.5pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify; padding-right: 0.35in"><FONT STYLE="font-family: Times New Roman, Times, Serif">Evaluation of efficacy
and safety of two dose strengths of SYN-010 (21 mg and 42 mg) compared to placebo </FONT></TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 4.5pt"></TD><TD STYLE="width: 13.5pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify; padding-right: 0.35in"><FONT STYLE="font-family: Times New Roman, Times, Serif">Conducted in approximately
150 clinical sites in North America</FONT></TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 4.5pt"></TD><TD STYLE="width: 13.5pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify; padding-right: 0.35in"><FONT STYLE="font-family: Times New Roman, Times, Serif">Study subjects
will be randomized in a 1:1:1 ratio, receiving either 21 mg of SYN-010, 42 mg of SYN-010, or placebo</FONT></TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 4.5pt"></TD><TD STYLE="width: 13.5pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify; padding-right: 0.35in"><FONT STYLE="font-family: Times New Roman, Times, Serif">Enrollment open
to all IBS-C patients; breath-methane will be measured at baseline to ensure a comparable ratio of high-to-low breath methane IBS-C
patients in each treatment arm</FONT></TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 4.5pt"></TD><TD STYLE="width: 13.5pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify; padding-right: 0.35in"><FONT STYLE="font-family: Times New Roman, Times, Serif">An interim futility
analysis may be conducted when approximately 50% of patients in each dosing arm have completed treatment</FONT></TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.35in 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 1.8pt 0pt 0; text-align: justify">Consistent with FDA written guidance,
the primary objective for this study is to determine the efficacy of SYN-010, measured as an improvement from baseline in the percentage
of overall weekly responders<FONT STYLE="color: black"><SUP>1</SUP></FONT> during the 12-week treatment period for SYN-010 21
mg and 42 mg daily doses compared to placebo. Secondary efficacy endpoints for both dose strengths of SYN-010 will measure changes
from baseline in abdominal pain, bloating, bowel movement frequency and stool consistency. Exploratory outcomes include Adequate
Relief and quality of life measures using the well-validated EQ-5D-5L and PAC-SYM patient questionnaires.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 1.8pt 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><SUP>1</SUP> An overall 12-week responder
is defined as a subject with a weekly response in at least 50% of the weeks of treatment (6 of 12 weeks). Weekly Responder is
defined as a patient who experiences a decrease in weekly average score for worst abdominal pain in the past 24 hours of at least
30% compared with Study 1 Baseline and a stool frequency increase of 1 or more CSBM per week compared with Study 1 Baseline.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">The press release is attached as Exhibit 99.1 to this report
on Form 8-K and is incorporated herein by reference.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Item 9.01. Financial Statements and Exhibits.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">(d) Exhibits</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

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    <TD STYLE="vertical-align: top; width: 8%; border-bottom: black 1pt solid">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Exhibit</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">No.</P></TD>
    <TD STYLE="vertical-align: top; width: 1%">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; width: 91%; border-bottom: black 1pt solid; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Description</FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">99.1</FONT></TD>
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Synthetic Biologics, Inc. press release dated January 18, 2017</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SIGNATURES</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">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 hereunto duly authorized.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Dated: January 18, 2017</FONT></TD>
    <TD COLSPAN="2"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">SYNTHETIC BIOLOGICS, INC.</FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD COLSPAN="2"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(Registrant)</FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 51%">&nbsp;</TD>
    <TD STYLE="width: 3%">&nbsp;</TD>
    <TD STYLE="width: 46%">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">By:</FONT></TD>
    <TD STYLE="border-bottom: black 1pt solid"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">/s/ Jeffrey Riley</FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Name: Jeffrey Riley</FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Title: President and Chief Executive Officer</FONT></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<TYPE>EX-99.1
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<FILENAME>v457123_ex99-1.htm
<DESCRIPTION>EXHIBIT 99.1
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<P STYLE="margin: 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right"><B>Exhibit 99.1&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><IMG SRC="image_001.jpg" ALT="">&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Synthetic Biologics Confirms Key Features
of Pivotal Phase 2b/3 Trial of SYN-010 </B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Pursuant to Consultations with FDA </B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: center"><B><I>-- Enrollment in SYN-010
Pivotal Trial Will Be Open to All IBS-C Patients --</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><I>&nbsp;</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>For Immediate Release</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>Rockville, MD, January 18, 2017 &ndash;
</B><U>Synthetic Biologics, Inc.</U> (NYSE MKT: SYN), a late-stage clinical company developing therapeutics designed to preserve
the microbiome to protect and restore the health of patients, today confirmed plans to initiate a Phase 2b/3 adaptive pivotal
trial for SYN-010, the Company&rsquo;s modified-release reformulation of lovastatin lactone designed to reduce methane production
by certain microorganisms (<I>M. smithii) </I>in the gut to treat the underlying cause of irritable bowel syndrome with constipation
(IBS-C). The Company anticipates initiating this trial by the end of the first quarter of 2017.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In accordance with collaborative discussions
with the FDA, key components of the SYN-010 Phase 2b/3 adaptive pivotal trial will include:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 4.5pt"></TD><TD STYLE="width: 13.5pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify; padding-right: 1.8pt">A 12-week, multi-center, double-blind, placebo-controlled, adaptive design
clinical trial</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 4.5pt"></TD><TD STYLE="width: 13.5pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify; padding-right: 0.35in">A study population of approximately 840 adult subjects diagnosed with IBS-C</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 4.5pt"></TD><TD STYLE="width: 13.5pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify; padding-right: 0.35in">Evaluation of efficacy and safety of two dose strengths of SYN-010 (21 mg
and 42 mg) compared to placebo</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 4.5pt"></TD><TD STYLE="width: 13.5pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify; padding-right: 0.35in">Conducted in approximately 150 clinical sites in North America</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 4.5pt"></TD><TD STYLE="width: 13.5pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify; padding-right: 0.35in">Study subjects will be randomized in a 1:1:1 ratio, receiving either 21
mg of SYN-010, 42 mg of SYN-010, or placebo</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 4.5pt"></TD><TD STYLE="width: 13.5pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify; padding-right: 0.35in">Enrollment is open to all IBS-C patients; breath-methane will be measured
at baseline to ensure a comparable ratio of high-to-low breath methane IBS-C patients in each treatment arm</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 4.5pt"></TD><TD STYLE="width: 13.5pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify; padding-right: 0.35in">An interim futility analysis may be conducted when approximately 50% of
patients in each dosing arm have completed treatment</TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&ldquo;We are pleased with the
direction that we received from the FDA on the clinical trial design for SYN-010,&rdquo; said Jeffrey Riley, President and
Chief Executive Officer. &ldquo;With a clear path forward for SYN-010&rsquo;s clinical development, we are one step closer to
achieving our goal of providing patients with a novel, potentially best-in-class therapy that directly targets a cause of
IBS-C, thereby alleviating symptoms and preventing their recurrence.&rdquo;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.35in 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 1.8pt 0pt 0; text-align: justify">Consistent with FDA written guidance,
the primary objective for this study is to determine the efficacy of SYN-010, measured as an improvement from baseline in the percentage
of overall weekly responders<FONT STYLE="font-family: Times New Roman, Times, Serif; color: black"><SUP>1</SUP></FONT> during
the 12-week treatment period for SYN-010 21 mg and 42 mg daily doses compared to placebo. Secondary efficacy endpoints for both
dose strengths of SYN-010 will measure changes from baseline in abdominal pain, bloating, bowel movement frequency and stool consistency.
Exploratory outcomes include Adequate Relief and quality of life measures using the well-validated EQ-5D-5L and PAC-SYM patient
questionnaires.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><SUP>1</SUP> An overall 12-week responder
is defined as a subject with a weekly response in at least 50% of the weeks of treatment (6 of 12 weeks). Weekly Responder is defined
as a patient who experiences a decrease in weekly average score for worst abdominal pain in the past 24 hours of at least 30% compared
with Study 1 Baseline and a stool frequency increase of 1 or more CSBM per week compared with Study 1 Baseline.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Synthetic Biologics also recently announced
the achievement of the primary endpoint from its Phase 2b proof-of-concept clinical trial of SYN-004 (ribaxamase). Preliminary
analysis of the data demonstrated a statistically significant reduction in both <I>C. difficile</I> infection (CDI) (p-value=0.045;
relative risk reduction of 71.4%) and new colonization by vancomycin-resistant enterococci (VRE) (p-value=0.0002) for patients
receiving ribaxamase compared to placebo.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>About Irritable Bowel Syndrome</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">IBS affects an estimated 10 to 15 percent
of the population, or as many as 45 million people in North America. The illness affects both men and women; however, two-thirds
of diagnosed sufferers are women. It has been reported that up to 20 percent of all IBS patients have IBS-C and current FDA-approved
therapies for the treatment of IBS-C, which include prescription and over-the-counter laxatives, do little to treat the underlying
cause of the disease. These products provide patients with temporary relief from the symptoms of constipation by elevating the
amount of water which passes through the gastrointestinal tract, but tend to cause an IBS-C patient to swing from suffering from
constipation, to suffering from diarrhea.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>About SYN-010</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">SYN-010 is a proprietary, modified-release
formulation of lovastatin lactone that is intended to reduce methane production by certain microorganisms (<I>M. smithii</I>)
in the gut while minimizing disruption to the microbiome to treat an underlying cause of IBS-C. SYN-010 is intended to act primarily
in the intestinal lumen while avoiding systemic absorption, thereby targeting a major cause of IBS-C, not just the symptoms. To
access the SYN-010 mechanism of action video on Synthetic Biologics&rsquo; website, please <U>click here</U>.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>About Synthetic Biologics, Inc.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Synthetic Biologics, Inc. (NYSE MKT: SYN)
is a late-stage clinical company developing therapeutics designed to preserve the microbiome to protect and restore the health
of patients. The Company's lead candidates poised for Phase 3 development are: (1) SYN-010 which is intended to reduce the impact
of methane producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation
(IBS-C), and (2) SYN-004 (ribaxamase) which is designed to protect the gut microbiome from the effects of certain commonly used
intravenous (IV) beta-lactam antibiotics for the prevention of <I>C. difficile</I> infection (CDI), antibiotic-associated diarrhea
(AAD) and the emergence of antimicrobial-resistance (AMR). The Company is also developing preclinical stage monoclonal antibody
therapies for the prevention and treatment of pertussis and novel discovery stage biotherapeutics for the treatment of phenylketonuria
(PKU). For more information, please visit Synthetic Biologics' website at <U>www.syntheticbiologics.com</U>.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="color: #333333"><I>This release
includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases,
forward-looking statements can be identified by terminology such as &quot;may,&quot; &quot;should,&quot; &quot;potential,&quot;
&quot;continue,&quot; &quot;expects,&quot; &quot;anticipates,&quot; &quot;intends,&quot; &quot;plans,&quot; &quot;believes,&quot;
&quot;estimates&quot; and similar expressions and include statements regarding </I></FONT><I>plans to initiate a Phase 2b/3 adaptive
pivotal trial for SYN-010 towards the end of quarter 1 2017, the size of the market, potential of SYN-010 to reduce methane production
for the treatment of IBS-C</I> and <I>to protect the microbiome</I>, and <I>the size of the market <FONT STYLE="color: #333333">These
forward-looking statements are based on management's expectations and assumptions as of the date of this press release and are
subject to a number of risks and uncertainties that could cause actual results to differ materially from those set forth or implied
by any forward-looking statements.</FONT></I><FONT STYLE="color: #333333">&nbsp;<I>Important factors that could cause actual results
to differ materially from current expectations include, among others, Synthetic Biologics' product candidates demonstrating safety
and effectiveness, as well as results that are consistent with prior results, Synthetic Biologics' ability to initiate clinical
trials and if initiated, to complete them on time and achieve desired results and benefits, Synthetic Biologics' clinical trials
continuing enrollment as expected, Synthetic Biologics' ability to obtain regulatory approvals for commercialization of product
candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to Synthetic Biologics' ability to
promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace
and the successful development, marketing or sale of Synthetic Biologics' products by competitors that render Synthetic Biologics'
products obsolete or non-competitive, Synthetic Biologics' ability to maintain its license agreements, the continued maintenance
and growth of Synthetic Biologics'</I>&nbsp;<I>patent estate, Synthetic Biologics becoming and remaining profitable, Synthetic
Biologics'</I>&nbsp;<I>ability to establish and maintain collaborations, Synthetic Biologics'</I>&nbsp;<I>ability to obtain or
maintain the capital or grants necessary to fund its research and development activities, a loss of any of Synthetic Biologics'</I>&nbsp;<I>key
scientists or management personnel,</I>&nbsp;<I>and other factors described in Synthetic Biologics' Annual Report on Form 10-K
for the year ended December 31, 2015 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and
8-K.The information in this release is provided only as of the date of this release, and Synthetic Biologics undertakes no obligation
to update any forward-looking statements contained in this release on account of new information, future events, or otherwise,
except as required by law. </I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>For further information, please contact:</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Synthetic Biologics, Inc. (Corporate and
Investors)</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Vincent I. Perrone, Manager Corporate Communication, (240)
660-2000, <U>info@syntheticbiologics.com</U></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Feinstein Kean Healthcare (Media)</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Gregory Kelley, Senior Vice President, (404) 836-2302, <U>gregory.kelley@fkhealth.com</U></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"># # #</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>



<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>



<P STYLE="margin: 0"></P>

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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
