Synlogic Presents Preclinical Data from Synthetic BioticTM Medicine, SYNB1618, for the Treatment of Phenylketonuria

From Startup Synlogic Tx

Link to Full Article:

– SYNB1618 currently being evaluated in a Phase 1/2a clinical trial
in healthy volunteers and patients with Phenylketonuria (PKU); interim
data expected in 2H 2018 –

– Data presented in plenary session at ASM Microbe 2018 demonstrate
lowering of blood phenylalanine (Phe) levels in an animal model of PKU
and non-human primates (NHPs) –

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Jun. 11, 2018–
Synlogic, Inc. (Nasdaq:
SYBX), a clinical-stage drug discovery and development company
applying synthetic biology to probiotics to develop novel living
medicines, today announced the presentation of preclinical data from
SYNB1618, an investigational Synthetic Biotic medicine currently being
evaluated in an ongoing Phase 1/2a clinical trial in healthy volunteers
and patients with PKU. The data demonstrate that oral administration of
SYNB1618 resulted in lower blood Phe levels and a quantitative,
dose-dependent production of biomarkers indicating SYNB1618-related
activity in an animal model of PKU and healthy NHPs. The presentation
was featured in a plenary session at the annual meeting of the American
Society for Microbiology (ASM Microbe 2018), which is being held from
June 7-11 in Atlanta, GA.

“For patients with PKU, life-long disease management can be challenging
due to the protein-restricted diet required to accompany currently
available treatments. We are encouraged by the preclinical data
presented at ASM Microbe, which support the development of orally
administered SYNB1618 as a potentially broadly applicable therapeutic
option for patients,” said Aoife Brennan, M.B., B.Ch., Synlogic’s
interim president and chief executive officer and chief medical officer.
“We are currently exploring production of these same biomarkers in an
ongoing Phase 1/2a clinical trial in healthy volunteers and patients
with PKU, and look forward to reporting interim safety data from the
dose-escalation portion of this trial in the second half of 2018.”

Synlogic’s Synthetic Biotic medicines for the treatment of inborn errors
of metabolism, such as PKU, are designed to function in the
gastrointestinal (GI) tract to convert metabolites that can build up to
toxic levels in the blood into harmless metabolites that can be excreted
from the body. SYNB1618 is a strain of a probiotic bacterium, E.coli Nissle,
that has been engineered to metabolize Phe, an essential amino acid that
at high blood levels can lead to cognitive damage, into harmless
compounds, including trans-cinnamic acid (TCA). TCA can be further
metabolized in the liver and excreted as hippurate in the urine,
suggesting TCA and hippurate are potentially quantitative biomarkers of
SYNB1618 activity.

In a Plenary Session at ASM Microbe, “Precision Microbiology,” Synlogic
scientist, Vincent Isabella, Ph.D., presented data, demonstrating that:

Phe is abundant in the small intestine and is derived from two
sources, the diet and the blood. Phe in the blood re-enters the GI
tract in the form of enzymes and secretions via a process known as
enterorecirculation; and

In a mouse model of PKU and in healthy NHPs, orally administered
SYNB1618 can result in significant decreases in blood Phe levels and
dose-responsive pharmacokinetics, as determined by dose-dependent
production of biomarkers, such as plasma TCA and urinary hippurate.

More information about Synlogic’s Phase1/2a clinical trial in healthy
adult volunteers and patients with PKU, can be found at
under the study ID NCT03516487.

About Phenylketonuria (PKU)PKU is caused by a defect in the
gene encoding phenylalanine hydroxylase (PAH), a liver enzyme that
metabolizes Phe. Phe is an essential amino acid that enters the body as
a component of dietary protein and can be toxic if it accumulates in the
blood and brain. Current disease management of PKU involves strict
dietary protein restriction with the consumption of Phe-free protein
supplements. Life-long Phe control is challenging due to the highly
restrictive nature of the diet and patients typically experience
worsening neurological function depending on the severity of their
genetic mutation and their treatment compliance. PKU is diagnosed at
birth, and the National PKU Alliance estimates that there are currently
16,500 people living with the disorder in the U.S.

About SynlogicSynlogic is pioneering the development of a
novel class of living medicines, Synthetic Biotic medicines, based on
its proprietary drug development platform. Synlogic leverages the tools
and principles of synthetic biology to genetically engineer probiotic
microbes to perform or deliver critical functions missing or damaged due
to disease. The company’s two lead programs, SYNB1020 and SYNB1618,
target hyperammonemia as a result of liver damage or genetic disease,
and PKU, respectively. When delivered orally, Synthetic Biotic medicines
can act from the gut to compensate for the dysfunctional metabolic
pathway and have a systemic effect, with the potential to significantly
improve symptoms of disease for affected patients. In addition, the
company is leveraging the broad potential of its platform to create
Synthetic Biotic medicines for the treatment of more common diseases,
including liver disease, inflammatory and immune disorders, and cancer.
Synlogic is collaborating with AbbVie to develop Synthetic Biotic-based
treatments for inflammatory bowel disease (IBD). For more information,
please visit

Forward-Looking StatementsThis 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, 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,”
“estimate,” “expect,” “intend,” “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 platform to develop therapeutics to address a wide range of
diseases including: cancer, inborn errors of metabolism, liver disease,
and inflammatory and immune disorders; the future clinical development
of Synthetic Biotic medicines; the approach Synlogic is taking to
discover and develop novel therapeutics using synthetic biology; the
potential of Synlogic’s technology to treat cancer, hyperammonemia, and
phenylketonuria. Actual results could differ materially from those
contained in any forward-looking statement as a result of various
factors, including: the uncertainties inherent in the 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 SEC. 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

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Synlogic, Inc.MEDIA CONTACT:Courtney Heath,
CONTACT:Elizabeth Wolffe, Ph.D.,

Please visit their site for more information: Synlogic

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2018-06-22 05:23:59