Full Press Release Details
Synthetic Biologics Reports
Positive Safety Data on SYN-020 Intestinal Alkaline Phosphatase
Phase 1 Multiple Ascending
-Orally administered SYN-020
observed to be well tolerated across all doses in healthy volunteers-
ROCKVILLE, MD - May 10, 2022 (GLOBE NEWSWIRE)
-- Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company developing therapeutics designed to treat diseases
in areas of high unmet need, today announced positive safety data from its Phase 1, placebo-controlled, double-blind multiple ascending
dose (MAD) clinical trial of SYN-020 intestinal alkaline phosphatase (IAP). The Phase 1 MAD study enrolled 32 healthy adult volunteers
into four cohorts with SYN-020 administered orally in doses ranging from 5 mg to 75 mg twice daily for 14 days with a follow-up evaluation
at day 35. Each cohort included six subjects who received SYN-020 and two who received placebo. Analyses of preliminary data demonstrated
that SYN-020 maintained a favorable safety profile and was well-tolerated across all dose levels. There were a few treatment-related adverse
events, and all were mild (grade 1) and resolved without medical intervention. The most common adverse event, constipation, occurred in
three out of 24 subjects in the treatment arm and in one out of eight subjects in the placebo arm. No adverse event led to discontinuation
of the study drug and there were no serious adverse events. SYN-020 levels were below the limit of quantitation in all plasma samples
at all timepoints during the study. Additional analyses, including fecal levels of SYN-020 and anti-drug antibody levels are on-going.
Both the previously reported Phase 1 single ascending
dose (SAD) study and the current MAD study are intended to support the development of SYN-020 in multiple clinical indications. The Company
is continuing to evaluate potential lead indications, which may include celiac disease, nonalcoholic fatty liver disease (NAFLD), and
radiation enteropathy as well as indications to treat and prevent metabolic and inflammatory disorders associated with aging. This latter
group of age-related clinical indications is supported by the Company's collaboration with Massachusetts General Hospital.
"SYN-020 is a promising, versatile asset
that has the potential to become a multi-indication therapeutic capable of addressing a considerable market opportunity and unmet need
for innovative, new therapies targeting disorders stemming from gastrointestinal (GI) inflammation," said Steven A. Shallcross,
Chief Executive Officer of Synthetic Biologics. "We will continue to explore the therapeutic potential of SYN-020 across indications
including celiac disease, NAFLD, age-related metabolic and inflammatory diseases. We are very encouraged by these positive Phase 1 results
and look forward to SYN-020's clinical advancement."
SYN-020 is a recombinant bovine IAP formulated
for oral delivery to the small intestine and designed to diminish fat absorption and intestinal inflammation, tighten the gut barrier
to mitigate "leaky gut," and promote a healthy microbiome. Despite its broad therapeutic potential, a key hurdle to commercialization
has been the high cost of IAP manufacture. Synthetic Biologics has overcome this hurdle and has the ability to produce SYN-020 at a scale
and cost viable for clinical and commercial development.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE American: SYN)
is a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need. The Company recently
consummated the acquisition of VCN Biosciences, S.L. (VCN), which is developing a new oncolytic adenovirus (OV) platform designed for
intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies
to the tumor, and promote a robust and sustained anti-tumor response by the patient's immune system. The Company's lead candidates
are: (1) VCN-01, an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor
stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment; (2) SYN-004 (ribaxamase) which
is designed to degrade certain commonly used intravenous (IV) beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent
(a) microbiome damage, (b) Clostridioides difficile infection (CDI), (c) overgrowth of pathogenic organisms, (d) the emergence
of antimicrobial resistance (AMR), and (e) acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT)
recipients, and (3) SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP conditions
and intended to treat both local GI and systemic diseases. For more information, please visit Synthetic Biologics' website at www.syntheticbiologics.com.
This release contains 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 "may," "should," "potential," "continue," "expects," "anticipates,"
"intends," "plans," "believes," "estimates," and similar expressions, and includes statements
regarding the Phase 1 SAD study and the current MAD study supporting the development of SYN-020 in multiple clinical indications,
continuing to explore the therapeutic potential of SYN-020 across indications, including celiac disease, NAFLD, and age-related metabolic
and inflammatory diseases, and the continued development of SYN-020. 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, many of which are difficult
to predict that could cause actual results to differ materially from current expectations and assumptions 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' ability to develop SYN-020 in multiple indications, including as a therapeutic for treatment of disorders
stemming from gastrointestinal (GI) inflammation, including celiac disease, NAFLD, and age-related metabolic and inflammatory diseases,
Synthetic Biologics' and VCN's product candidates demonstrating
safety and effectiveness, as well as results that are consistent with prior results; the ability to initiate and complete clinical trials
on time and achieve the desired results and benefits; continuing clinical trial enrollment as expected; the ability to obtain regulatory
approval for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating
to Synthetic Biologics' and VCN's ability to promote or commercialize their product candidates for the specific indications; acceptance
of product candidates in the marketplace and the successful development, marketing or sale of Synthetic Biologics' and VCN's products;
developments by competitors that render such products obsolete or non-competitive; Synthetic Biologics' and VCN's ability to maintain
license agreements;, the continued maintenance and growth of Synthetic Biologics' and VCN's patent estate; the ability to continue to
remain well financed;, and other factors described in Synthetic Biologics' Annual Report on Form 10-K for the year ended December 31,
2021 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.
For further information, please contact:
LifeSci Advisors, LLC