Synlogic Announces International Nonproprietary Name Selection for SYNB1934
28 Junho 2023 - 8:00AM
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 that the International Nonproprietary Names (INN) Expert
Committee of the World Health Organization (WHO-INN) has
selected "labafenogene marselecobac" for the nonproprietary name of
the company’s investigational drug for phenylketonuria (PKU),
previously known as SYNB1934. Naming attributes recognize
Synlogic’s proprietary technology and the company’s deep
appreciation for, and commitment to, the PKU community.
Labafenogene marselecobac is currently being evaluated in
Synpheny-3, a global pivotal clinical trial designed to evaluate
the efficacy and safety of the investigational drug as a treatment
for PKU. For more information about the Synpheny-3 clinical trial,
visit www.pkuresearchstudy.com.
“On the heels of initiating Synpheny-3, our pivotal study for
people living with PKU, receiving this INN marks another milestone
as we advance this potentially transformational therapeutic to the
many patients living with PKU who remain in need of a new medical
treatment,” said Aoife Brennan, M.B. Ch.B., Synlogic
President and Chief Executive Officer. “With this name, we
recognize PKU heroes: Mary and Sheila Jones, whose experience
demonstrated the life-changing effect of Phe control in PKU. Mary
and Sheila are honored in the prefix of this INN, ‘marselecobac,’
and it is fitting that we announce this tribute on June 28:
International PKU Awareness Day. It is our privilege to share and
celebrate this milestone with those living with PKU around the
world.”
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 to target and
consume Phe in the GI tract, by applying precision genetic
engineering to a well-characterized probiotic. 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) 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 follow us on Twitter or LinkedIn.
Forward-Looking Statements
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," “prepare” 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: media@synlogictx.com
Investor Relations: investor@synlogictx.com
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