ROCKVILLE, Md., April 14, 2021 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE American: SYN), a diversified
clinical-stage company leveraging the microbiome to develop
therapeutics designed to prevent and treat gastrointestinal (GI)
diseases in areas of high unmet need, today announced
enrollment has commenced and the first patient has been dosed in
its Phase 1b/2a clinical trial of
SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant
(HCT) recipients for the prevention of acute
graft-versus-host-disease (aGVHD). Broad spectrum intravenous (IV)
beta-lactam antibiotics used to treat infection following
conditioning chemotherapy for allogeneic HCT patients is a
necessary and oftentimes lifesaving intervention. However,
antibiotic-mediated damage of the gut microbiome in this patient
population has been strongly associated with adverse outcomes
including C. difficile infection (CDI), vancomycin-resistant
enterococci (VRE) colonization, potentially fatal bacteremia, and
aGVHD.
"Allogenic HCT recipients are at very high risk for infection
and frequently receive antibiotics," said Erik Dubberke, MD, Professor of Medicine and
Clinical Director of Transplant Infectious Diseases at Washington University School of Medicine in
St. Louis. "There is increasing
evidence that disruption of the microbiome caused by antibiotics
results in additional complications, including further infections.
If this trial shows that SYN-004 has a favorable safety profile and
is able to protect the microbiome, it would warrant study in larger
trials to determine if this treatment can improve outcomes in these
highly susceptible patients."
"We are very excited to begin enrollment of our SYN-004 Phase
1b/2a clinical trial in allogeneic
HCT recipients," said Steve A.
Shallcross, Chief Executive Officer of Synthetic Biologics.
"We are very grateful for the tremendous support from Dr. Dubberke
and his team at Washington University.
This clinical program is a critical component of our efforts to
expand and fortify the already well-established dataset for SYN-004
and our pursuit of a cost-effective development strategy in a
highly specialized patient population. We look forward to reporting
key clinical milestones as we advance the trial."
The single-center, randomized, double-blinded,
placebo-controlled clinical trial will evaluate the safety,
tolerability and potential absorption into the systemic circulation
(if any) of 150 mg oral SYN-004 administered four times per day to
allogeneic HCT recipients who receive an intravenous (IV)
beta-lactam antibiotic to treat fever. Study participants will be
enrolled into three sequential cohorts, with each receiving a
different study-assigned IV beta-lactam antibiotic. Eight
participants in each cohort will receive SYN-004 and four will
receive placebo. A data readout for the first cohort is anticipated
towards the end of 2021.
The study will also evaluate potential protective effects of
SYN-004 on the gut microbiome as well as generate preliminary
information on potential therapeutic benefits and patient outcomes
of SYN-004 in allogeneic HCT recipients. Safety and pharmacokinetic
data for each cohort will be reviewed by an independent Data and
Safety Monitoring Committee, which will make a recommendation on
whether to proceed to the next IV beta-lactam antibiotic.
Synthetic Biologics will serve as the sponsor of the clinical
trial and supply SYN-004 to Washington
University. Dr. Dubberke will serve as the principal
investigator along with his Washington
University colleague, Dr. Mark A.
Schroeder, Associate Professor of Medicine, Division of
Oncology, Bone Marrow Transplantation and Leukemia.
About the SYN-004 (ribaxamase) Phase 1b/2a Clinical Trial
SYN-004 (ribaxamase) is an oral prophylactic therapy 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 Clostridioides difficile infection (CDI),
overgrowth of pathogenic organisms, the emergence of antimicrobial
resistance (AMR) and acute graft-versus-host-disease (aGVHD) in
allogeneic hematopoietic cell transplant (HCT) recipients.
Allogeneic HCT recipients routinely receive long courses of IV
beta-lactam antibiotics to treat infection following conditioning
therapy. Antibiotic-mediated damage of the gut microbiome in
allogeneic HCT recipients may lead to adverse outcomes including
CDI, VRE colonization and potentially fatal bacteremia and aGVHD. A
previously completed placebo-controlled Phase 2b clinical trial of 412 patients
demonstrated SYN-004 protected the gut microbiome from
antibiotic-mediated dysbiosis. Patients who received SYN-004 also
demonstrated significantly better maintenance and recovery of the
gut microbiome as well as lower incidences of new colonization by
opportunistic and potentially pathogenic microorganisms such as
VRE.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE American: SYN) is a diversified
clinical-stage company leveraging the microbiome to develop
therapeutics designed to prevent and treat gastrointestinal (GI)
diseases in areas of high unmet need. The Company's lead candidates
are: (1) 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 (2) 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 a data readout from the first cohort towards the
end of 2021, the potential of SYN-004 to significantly improve
outcomes for allogenic HCT recipient and the intended
benefits to be derived from SYN-004 and 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 provide data towards the end of 2021, the ability
to continue to comply with continued listing
requirements of the NYSE American, the ability of its product
candidates to demonstrate safety and effectiveness, as well as
results that are consistent with prior results, Synthetic
Biologics' clinical trials continuing and/or beginning enrollment
as expected, a failure to receive the necessary regulatory
approvals for commencement of clinical trials and commercialization
of Synthetic Biologics' therapeutics, including approval of
proposed trial designs, a failure of Synthetic Biologics' clinical
trials, and those conducted by investigators, for SYN-004 and
SYN-020 to be commenced or completed on time or to achieve desired
results and benefits, a failure of Synthetic Biologics' clinical
trials to continue enrollment as expected or receive anticipated
funding, a failure of Synthetic Biologics to successfully develop,
market or sell its products, Synthetic Biologics' inability to
maintain its material licensing agreements, or a failure by
Synthetic Biologics or its strategic partners to successfully
commercialize products, Synthetic Biologics' ability to achieve
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, the continued maintenance and growth
of Synthetic Biologics' patent estate, Synthetic Biologics becoming
and remaining profitable, Synthetic Biologics' ability to obtain or
maintain the capital or grants necessary to fund its research and
development activities, a loss of any of Synthetic Biologics' key
scientists or management personnel and other factors described in
Synthetic Biologics' Form 10-K for the year ended December 31, 2020 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.
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SOURCE Synthetic Biologics, Inc.