Synlogic Announces Publication of Synpheny-1 Phase 2 Study of Synthetic Biotic for Phenylketonuria in Nature Metabolism
September 28 2023 - 11:15AM
Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology
company advancing novel, oral, non-systemically absorbed
biotherapeutics to transform the care of serious diseases, today
announced the publication of results from its Synpheny-1 Phase 2
study of its drug candidates, labafenogene marselecobac (SYNB1934)
and SYNB1618 in patients with phenylketonuria (PKU) in the journal
Nature Metabolism.
The publication, entitled “Efficacy and Safety of a
Synthetic Biotic for Treatment of Phenylketonuria: a Phase 2
Clinical Trial” is now available online at
https://www.nature.com/articles/s42255-023-00897-6. The paper
includes a comprehensive review of the data, showing clinically
meaningful, dose-dependent reductions in plasma phenylalanine
(Phe).
“These positive results build on a body of data
supporting the role of labafenogene marselecobac for patients with
PKU,” said Dr. Neal Sondheimer, Head of Clinical Development at
Synlogic. “These findings re-enforce our urgency to complete
Synpheny-3, the pivotal trial now underway, and advance this
potential new treatment to the many patients who need it.”
The study was completed with the participation of
clinical teams at University of Pittsburgh, Mount Sinai Hospital,
Washington University, Oregon Health & Science University,
University of Texas-Houston, Vanderbilt University, University of
Colorado and University of Florida.
About
labafenogene marselecobac (SYNB1934)
Labafenogene marselecobac (SYNB1934) is an orally
administered, non-systemically absorbed, potential treatment for
phenylketonuria (PKU), a rare metabolic disease caused by inherited
mutations that impair the breakdown of phenylalanine (Phe), an
amino acid found in all protein-containing foods. The goal of PKU
management is to reduce plasma Phe below neurotoxic levels,
reducing risk of neurocognitive complications. Current treatment
options for PKU are limited due to safety and efficacy, leaving the
majority of people living with PKU without medical management and
with uncontrolled Phe. Synlogic designed labafenogene
marselecobac by applying precision genetic engineering to a
well-characterized probiotic to target and consume Phe in the GI
tract. Results to date indicate the potential for labafenogene
marselecobac as the first therapeutic for PKU approved as both a
monotherapy and adjunctive medical treatment, and following
successful Phase 2 results, it has advanced to Synpheny-3, a
global, pivotal Phase 3 study. Labafenogene marselecobac has
received Orphan Drug Designation (ODD), Fast Track designation and
Rare Pediatric Disease Designation (RPDD) from the FDA in
addition to orphan designation from the European Medicines
Agency (EMA).
About Synlogic
Synlogic is a clinical-stage biotechnology company
advancing novel, oral, non-systemically absorbed biotherapeutics to
transform the care of serious diseases in need of new treatment
options. The Company’s late-stage pipeline is focused on rare
metabolic diseases, led by labafenogene marselecobac (SYNB1934),
currently being studied as a potential treatment for
phenylketonuria (PKU) in Synpheny-3, a global, pivotal Phase 3
study. Additional product candidates address diseases including
homocystinuria (HCU), enteric hyperoxaluria, gout, and cystinuria.
This pipeline is fueled by the Synthetic Biotic platform, which
applies precision genetic engineering to well-characterized
probiotics. This enables Synlogic to create GI-restricted, oral
medicines designed to consume or modify disease-specific
metabolites – an approach well suited for PKU and HCU, both inborn
errors of metabolism, as well as other disorders in which the
disease–specific metabolites transit through the GI tract,
providing validated targets for these Synthetic Biotics. Research
activities include a partnership with Roche focused on inflammatory
bowel disease (IBD), and a collaboration with Ginkgo Bioworks in
synthetic biology, which has contributed to two pipeline programs
to date. For more information, please visit www.synlogictx.com or
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This press release contains "forward-looking
statements" that involve substantial risks and uncertainties for
purposes of the safe harbor provided by the Private Securities
Litigation Reform Act of 1995. All statements, other than
statements of historical facts, included in this press release
regarding strategy, future operations, clinical development plans,
future financial position, future revenue, projected expenses,
prospects, plans and objectives of management are forward-looking
statements. In addition, when or if used in this press release, the
words "may," "could," "should," "anticipate," "believe," "look
forward," "estimate," "expect," "intend," "on track," "plan,"
"predict" and similar expressions and their variants, as they
relate to Synlogic, may identify forward-looking statements.
Examples of forward-looking statements, include, but are not
limited to, statements regarding the potential
of Synlogic's approach to Synthetic Biotics to develop
therapeutics to address a wide range of diseases including: inborn
errors of metabolism and inflammatory and immune disorders; our
expectations about sufficiency of our existing cash balance; the
future clinical development of Synthetic Biotics; the
approach Synlogic is taking to discover and develop novel
therapeutics using synthetic biology; and the expected timing
of Synlogic's clinical trials of labafenogene
marselecobac (SYNB1934), SYNB1353, SYNB8802 and SYNB2081 and
availability of clinical trial data. Actual results could differ
materially from those contained in any forward-looking statements
as a result of various factors, including: the uncertainties
inherent in the clinical and preclinical development process; the
ability of Synlogic to protect its intellectual property
rights; and legislative, regulatory, political and economic
developments, as well as those risks identified under the heading
"Risk Factors" in Synlogic's filings with the U.S.
Securities and Exchange Commission. The forward-looking statements
contained in this press release
reflect Synlogic's current views with respect to future
events. Synlogic anticipates that subsequent events and
developments will cause its views to change. However,
while Synlogic may elect to update these forward-looking
statements in the future, Synlogic specifically disclaims
any obligation to do so. These forward-looking statements should
not be relied upon as representing Synlogic's view as of
any date subsequent to the date hereof.
Media Contact:
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