<SEC-DOCUMENT>0001144204-17-000723.txt : 20170105
<SEC-HEADER>0001144204-17-000723.hdr.sgml : 20170105
<ACCEPTANCE-DATETIME>20170105070534
ACCESSION NUMBER:		0001144204-17-000723
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20170105
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20170105
DATE AS OF CHANGE:		20170105

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:		17508669

	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>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>v456270_8k.htm
<DESCRIPTION>8-K
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<P STYLE="margin: 0"></P>

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

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

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

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

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

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

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center">Date of Report (Date of earliest event reported):
January 5, 2017</P>

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

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

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

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

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

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

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

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

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

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

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

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

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

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Wingdings">&uml;</FONT></TD><TD><FONT STYLE="font-family: Times New Roman, Times, Serif">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: 0 0 0 0.25in; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Wingdings">&uml;</FONT></TD><TD><FONT STYLE="font-family: Times New Roman, Times, Serif">Soliciting material pursuant to Rule 14a-12 under the Exchange Act
(17 CFR 240.14a-12)</FONT></TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 0.25in; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Wingdings">&uml;</FONT></TD><TD><FONT STYLE="font-family: Times New Roman, Times, Serif">Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))</FONT></TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 0.25in; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Wingdings">&uml;</FONT></TD><TD><FONT STYLE="font-family: Times New Roman, Times, Serif">Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))</FONT></TD></TR></TABLE>

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


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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">Synthetic Biologics, Inc. (the &ldquo;Company&rdquo;)
today issued a press release announcing positive topline data from its Phase 2b clinical trial for SYN-004 (ribaxamase), the Company&rsquo;s
first-in-class oral enzyme designed to protect the gut microbiome from disruption caused by certain intravenous (IV) beta-lactam
antibiotics. The trial, a randomized, double-blind, placebo controlled trial of 412 patients, met its primary endpoint of significantly
reducing <I>C. difficile</I> Infection (CDI). Preliminary analysis of the data indicates seven confirmed cases of CDI in the placebo
group compared to two cases in the ribaxamase treatment group. Patients receiving ribaxamase achieved a 71.4% relative risk reduction
(p-value=0.045) in CDI rates compared to patients receiving placebo. Adverse events reported during this trial were comparable
between treatment and placebo arms.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">Synthetic Biologics is also in the process
of analyzing data from several exploratory endpoints that were designed to evaluate ribaxamase&rsquo;s ability to protect the gut
microbiome from colonization by opportunistic bacteria such as <I>C. difficile</I> and other antibiotic-resistant pathogens. Preliminary
analysis of the data demonstrated a significant reduction in new colonization by vancomycin-resistant enterococci (VRE) for patients
receiving ribaxamase compared to placebo (p-value=0.0002). The study included a secondary endpoint to assess ribaxamase&rsquo;s
capacity to decrease the incidence of antibiotic-associated diarrhea from all cases. Preliminary analysis of the data suggested
a trend towards such a reduction (p-value=0.13), which was due, for the most part, to the reduction of CDI.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">These data are consistent with ribaxamase&rsquo;s
mechanism of action designed to protect and preserve the natural balance of the gut microbiome from the unintended effects of IV
antibiotic use. The Company expects to share additional results from these exploratory endpoints as they become available later
this year, including results focused on ribaxamase&rsquo;s ability to prevent the emergence of antimicrobial resistance in the
gut microbiome.</P>

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

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

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

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

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

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

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        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; text-align: center">Exhibit</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; text-align: center">No.</P></TD>
    <TD STYLE="width: 2%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></TD>
    <TD STYLE="width: 89%; border-bottom: Black 1pt solid; text-align: center; vertical-align: bottom"><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 5, 2017</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in">&nbsp;</P>


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

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

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

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

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<TR STYLE="vertical-align: top">
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Dated: January 5, 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: 50%">&nbsp;</TD>
    <TD STYLE="width: 4%">&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: 0">&nbsp;</P>



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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; text-align: center"><IMG SRC="pg1img1_ex99-1.jpg" ALT="">&nbsp;</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center"><B>Synthetic Biologics&rsquo; SYN-004 (ribaxamase)
Achieves Primary Endpoint in Phase 2b Trial </B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center"><B>for <I>C. difficile</I> Infection (CDI) </B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: center"><B><I>&mdash; Presentation Planned for 9:30am
(PT), Jan. 9, 2017 at Biotech Showcase in San Francisco &mdash;</I></B></P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><B>Rockville, MD, January 05, 2017 &ndash;</B>
<U>Synthetic Biologics, Inc.</U> (NYSE MKT: SYN), a late-stage clinical company developing therapeutics that preserve the microbiome
to protect and restore the health of patients, today announced positive topline data from its Phase 2b clinical trial for SYN-004
(ribaxamase), the Company&rsquo;s first-in-class oral enzyme designed to protect the gut microbiome from disruption caused by certain
intravenous (IV) beta-lactam antibiotics.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">The study, a randomized, double-blind, placebo
controlled trial of 412 patients, met its primary endpoint of significantly reducing <I>C. difficile</I> Infection (CDI). Preliminary
analysis of the data indicated seven confirmed cases of CDI in the placebo group compared to two cases in the ribaxamase treatment
group. Patients receiving ribaxamase achieved a 71.4% relative risk reduction (p-value=0.045) in CDI rates compared to patients
receiving placebo. Adverse events reported during this trial were comparable between treatment and placebo arms.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">Synthetic Biologics is also in the process
of analyzing data from several exploratory endpoints that were designed to evaluate ribaxamase&rsquo;s ability to protect the gut
microbiome from colonization by opportunistic bacteria such as <I>C. difficile</I> and other antibiotic-resistant pathogens. Preliminary
analysis of the data demonstrated a significant reduction in new colonization by vancomycin-resistant enterococci (VRE) for patients
receiving ribaxamase compared to placebo (p-value=0.0002). With agreement from the FDA, the study included a secondary endpoint
to assess ribaxamase&rsquo;s capacity to decrease the incidence of antibiotic-associated diarrhea from all causes. Preliminary
analysis of the data suggested a trend towards such a reduction (p-value=0.13), which was due, for the most part, to the reduction
of CDI.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">These data are consistent with ribaxamase&rsquo;s
mechanism of action designed to protect and preserve the natural balance of the gut microbiome from the unintended effects of IV
antibiotic use. The Company expects to share additional results from these exploratory endpoints as they become available later
this year, including results focused on ribaxamase&rsquo;s ability to prevent the emergence of antimicrobial resistance in the
gut microbiome.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">&ldquo;These trial results provide a compelling
demonstration of the potential of ribaxamase to help address the serious health impacts associated with CDI and infections from
other opportunistic bacteria resulting from dysbiosis of the gut microbiome,&rdquo; said Joseph Sliman, MD, SVP, Clinical and Regulatory
Affairs. &ldquo;More than 453,000<SUP>1</SUP> patients are diagnosed with CDI annually in the U.S., resulting in approximately
29,000<SUP>1</SUP> deaths as well as significant and sometimes prolonged illness. Ribaxamase has the potential to shorten hospital
stays, diminish morbidity and mortality and reduce the emergence of antibiotic-resistant organisms in the gut microbiome by protecting
patients from primary <I>C. difficile</I> infection resulting from IV antibiotic use.&rdquo;</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">In addition to causing significant suffering
and mortality, CDI adds an estimated economic burden of nearly $1.5 billion<SUP>1</SUP> to the healthcare system each year, which
could potentially be reduced with an effective therapeutic.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">1: Leffler DA et al. N Engl J Med 2015; 372:
1539-1548</P>

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

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

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    <DIV STYLE="page-break-before: always; margin-top: 6pt; margin-bottom: 12pt"><P STYLE="margin: 0pt">&nbsp;</P></DIV>
    <!-- Field: /Page -->

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">&ldquo;The reduction in the relative risk
of CDI represents a significant milestone in the clinical development of ribaxamase and we believe provides further validation
for our approach to advancing cutting edge microbiome science,&rdquo; said Jeffrey Riley, President and Chief Executive Officer.
&ldquo;These findings also help further our goals to bring the first ever microbiome-focused therapeutic to patients and to help
illuminate the potential of this drug class to address serious diseases and public health concerns. We expect to share additional
data from exploratory endpoints in the coming months and look forward to continuing ongoing and productive discussions with both
the FDA and CDC on the protocol for Phase 3 pivotal trials for ribaxamase.&rdquo;</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">Synthetic Biologics is also continuing to prepare
for the initiation of pivotal Phase 2b/3 clinical trials for SYN-010, the Company&rsquo;s proprietary, modified-release formulation
of lovastatin lactone designed to treat the underlying cause of irritable bowel syndrome with constipation (IBS-C).</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><B>Presentation Planned for Biotech Showcase
2017 Conference</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><B>Date:</B> Monday, January 9, 2016</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><B>Time:</B> 9:30 a.m. (PT) / 12:30 p.m. (ET)</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><B>Location:</B> Hilton San Francisco Union
Square, San Francisco, CA</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">A live webcast of Synthetic Biologics&rsquo;
presentation may be accessed by logging onto the internet at <U>https://event.webcasts.com/viewer/event.jsp?ei=1130367</U>. After
the presentation, a replay will be archived and accessible for 90 days at the same website.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><B>About SYN-004 (ribaxamase) and the Phase
2b Study</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">SYN-004 (ribaxamase) is a first-in-class oral
enzyme designed to degrade certain IV beta-lactam antibiotics within the GI tract and maintain the natural balance of the gut microbiome
for the prevention of CDI, AAD and the emergence of antibiotic-resistant organisms. The Phase 2b proof-of-concept clinical trial
is intended to evaluate the effectiveness of ribaxamase to prevent the onset of primary <I>C. difficile</I> infection (CDI), antibiotic-associated
diarrhea (AAD) and the emergence of antibiotic-resistant organisms in patients hospitalized with a lower respiratory infection
and receiving IV ceftriaxone. A total of 412 subjects were randomized in a 1:1 ratio receiving either 150 mg dose strength of SYN-004
(ribaxamase) or placebo orally QID from Day 1 and until 72 hours following their last treatment of IV ceftriaxone. The sample size
was determined to provide 80% power to detect the treatment effect with a one-sided alpha of 0.05. P-values were determined based
on a 1-sided z-test for the comparison of the treatment difference as pre-specified in the statistical analysis plan. To access
the ribaxamase mechanism of action video on Synthetic Biologics' website, please click <U>here</U>.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">Synthetic Biologics, Inc. (NYSE MKT: SYN) is
a late-stage clinical company developing therapeutics that 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, antibiotic-associated diarrhea (AAD) and the
emergence of antibiotic-resistant organisms. 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: 0; text-align: justify">&nbsp;</P>

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

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    <DIV STYLE="page-break-before: always; margin-top: 6pt; margin-bottom: 12pt"><P STYLE="margin: 0pt">&nbsp;</P></DIV>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><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&rdquo; and similar expressions and include statements
regarding the potential of</I> <I>ribaxamase to help address the serious health impacts associated with CDI and infections from
other opportunistic bacteria resulting from dysbiosis of the gut microbiome, the industry data regarding the expected incidence
and economic burden of CDI, the potential of ribaxamase to shorten hospital stays, diminish morbidity and mortality and reduce
the emergence of antibiotic resistant organisms in the gut microbiome by protecting patients from primary C. difficile infection
resulting from IV antibiotic use, the potential to reduce the economic burden to the healthcare system from an effective therapeutic,
the suggested trend toward a reduction of incidence of antibiotic-associated diarrhea from all causes, the expected timing of data
release of exploratory endpoints of the trial focused on the ability of ribaxamase to prevent the emergence of antibiotic-resistant
organisms in the gut microbiome, the continued ongoing discussions with the FDA and CDC, validation for our approach to advancing
cutting edge microbiome science, the continued preparation for the initiation of pivotal Phase 2b/3 clinical trials for SYN-010,
the potential of the drug class to address serious diseases and public health concerns, the ability of SYN-004 to protect the gut
microbiome from the effects of certain commonly used IV beta-lactam antibiotics for the prevention of C. difficile infection, antibiotic-associated
diarrhea (AAD) and the emergence of antibiotic-resistant organisms. 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. 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></P>

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

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

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

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

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

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

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

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

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

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

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