Synlogic Progresses Clinical and Preclinical Pipeline and Outlines 2019 Catalysts

From Startup Synlogic Tx

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– Presentation of topline clinical data from studies of Synthetic
Biotic™ medicines, SYNB1020 and SYNB1618, in patients expected mid-2019 –
– Investigational New Drug (IND) application for SYNB1891, Synlogic’s
first immuno-oncology program, expected in 2H2019 –
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Jan. 3, 2019–
Inc. (Nasdaq: SYBX), a clinical-stage drug discovery and development
company applying synthetic biology to beneficial microbes to develop
novel living medicines, today provided an overview of recent progress
and outlined key objectives and anticipated milestones for 2019.

“2018 was a significant year for Synlogic as we advanced our two lead
clinical programs and platform. We have demonstrated proof of mechanism
in both programs in healthy volunteers and are currently evaluating
safety and activity in patients with disease. In addition, we broadened
our pipeline with the addition of our first immuno-oncology development
candidate, SYNB1891,” said Aoife Brennan, M.B. Ch.B., Synlogic’s
president and chief executive officer. “In 2019 we look forward to
presenting data from our two ongoing clinical programs that will inform
the development of our Synthetic Biotic platform. With the recent
expansion of our internal GMP-manufacturing capabilities, we are well
positioned to maintain the momentum of the past year and continue to
advance programs through clinical development as expeditiously as

2019 Goals and Catalysts
SYNB1020: An orally delivered, first-in-class, Synthetic
Biotic medicine designed for treatment of elevated blood ammonia
levels (hyperammonemia) in chronic liver disease or genetic urea cycle
disorders (UCDs).

In mid-2019, Synlogic expects to present top-line data from its
randomized, double-blind, placebo -controlled Phase 1b/2a clinical
trial evaluating SYNB1020 in patients with cirrhosis and elevated
ammonia. The main endpoints of the study are safety and
tolerability, as well as evidence of ammonia lowering in patients.

SYNB1618: An orally delivered, Synthetic Biotic medicine
designed for the treatment of phenylketonuria (PKU).

In mid-2019, Synlogic expects to present top-line data from its
randomized, double-blind, placebo-controlled Phase 1/2a clinical
trial evaluating SYNB1618 in patients with PKU. The study is
designed to evaluate safety and tolerability in this population as
well as pharmacokinetics and pharmacodynamics as determined by the
production of biomarkers specifically associated with SYNB1618

SYNB1891: Synlogic’s first immuno-oncology (IO)
development candidate, a STING agonist-producing Synthetic Biotic
medicine, designed to act as a dual innate immune activator, for the
treatment of non-immunologically responsive solid tumors.

In the second half of 2019 the Company expects to file an IND
application to enable advancement of SYNB1891 into a Phase 1
clinical study.

Pre-clinical data and early pipeline programs:
The company expects to publish and present data at major
scientific and medical meetings throughout the year demonstrating
the breadth and potential of its Synthetic Biotic platform.

Synlogic and AbbVie will continue to advance their ongoing
collaboration to develop a Synthetic Biotic medicine for the
treatment of inflammatory bowel disease (IBD).

Synlogic ended the third quarter of 2018 with $133 million in cash and
cash equivalents and expects that this will fund Company operations
through 2020 under its current plan.

The Company will continue to explore additional strategic
opportunities to expand the reach of its Synthetic Biotic platform.

2018 Accomplishments and Highlights:
Dosed first patient in Phase 1b/2a trial of SYNB1020 for the
treatment of hyperammonemia in patients with cirrhosis and
elevated ammonia. The clinical trial is a single and multiple
dose-escalation, randomized, double-blind, placebo-controlled
study of orally administered SYNB1020 in patients with cirrhosis
and elevated blood ammonia, designed to evaluate safety,
tolerability, kinetics, and pharmacodynamics as well as the
ability of SYNB1020 to lower blood ammonia. Synlogic enrolled and
treated an initial open-label sentinel cohort of six subjects with
mild disease to ensure that SYNB1020 was safe in patients with
liver disease who often have compromised barrier function and
might be susceptible to infection. This part of the study is
complete and Synlogic is enrolling patients with more advanced
disease with elevated blood ammonia at baseline.

Presented data supporting continued development of SYNB1020 for
the treatment of liver disease at the annual meeting of the
American Association for the Study of Liver Diseases
(AASLD). Synlogic presented data from a cross-sectional study
designed to establish ammonia measurement parameters and ammonia
levels in healthy volunteers at clinical sites that are
participating in Synlogic’s ongoing Phase 1b/2a clinical trial of
SYNB1020 in patients with cirrhosis and elevated ammonia.
Preclinical data from a rat model were also presented by
Synlogic’s collaborators that demonstrated dose-dependent lowering
of blood ammonia by Synthetic Biotic strains designed to consume
ammonia, confirming earlier preclinical observations in mouse
models of liver disease.

Announced positive interim data from the healthy volunteer arm of
its ongoing Phase 1/2a clinical trial evaluating SYNB1618 for the
treatment of PKU. The data demonstrated a statistically
significant, dose-dependent effect on treatment-associated
biomarkers, indicating proof-of-mechanism, and also established a
go-forward dose for the treatment arm in patients with PKU.

Published preclinical data in Nature Biotechnology
identifying key biomarkers of SYNB1618 activity in healthy animal
and disease models. The data demonstrated that oral administration
of SYNB1618 significantly reduced blood phenylalanine (Phe)
levels, the key metabolite associated with PKU, in mouse models of
PKU and resulted in dose-dependent pharmacodynamics in healthy
non-human primates (NHPs).

Fast Track designation granted to SYNB1618 for PKU by the U.S.
Food and Drug Administration (FDA).

Presented preclinical data highlighting the potential of Synthetic
Biotic medicines in IO and announced first IO clinical candidate at
the annual meeting of the Society for Immunotherapy of
Cancer (SITC). A webcast of the presentation
is available on the Synlogic website. Data presented at the
meeting demonstrate the platform’s potential for the treatment of
cancer and inflammation and specifically highlight the unique
advantages of Synlogic’s approach to stimulate the innate immune


Successfully completed two public offerings of common stock in January
and April, resulting in approximately $83 million in total net

The Company announced executive leadership changes including the
appointment of Aoife Brennan, M.B., B.Ch., as president and chief
executive officer, and the appointment of Antoine Awad as Head of
Technical Operations.

Synlogic expanded its manufacturing capabilities to enable production
of clinical trial material for its oral and immuno-oncology programs
via entry into an agreement to lease GMP clean-room space from
the Azzur Group, LLC. The agreement provides the Company with
infrastructure that enables advancement of clinical programs through
early and mid-phase studies and supports the production of both solid
and oral formulations.

Advanced collaboration with AbbVie to develop Synthetic Biotic-based
treatments for IBD resulting in payment to Synlogic of a $2.0 million

Synlogic was added to both the Russell 3000®Index and the NASDAQ
Biotechnology Index® (Nasdaq: NBI).

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 beneficial
microbes to perform or deliver critical functions missing or damaged due
to disease. Synthetic Biotic medicines are designed to act locally and
have a systemic effect to address disease in patients. Synlogic’s two
lead programs, SYNB1020 and SYNB1618, are orally administered and target
hyperammonemia as a result of liver damage or genetic disease, and
phenylketonuria, respectively. Synlogic is also developing SYNB1891 as
an intratumorally administered Synthetic Biotic medicine for the
treatment of cancer. In addition, the company is leveraging the broad
potential of its platform to create additional Synthetic Biotic
medicines for the treatment of liver disease, as well as inflammatory
and immune disorders including Synlogic’s collaboration 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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Source: Synlogic, Inc.
MEDIA CONTACT:Courtney HeathPhone: 617-872-2462Email:
INVESTOR CONTACT:Elizabeth Wolffe, Ph.D.Phone:

Please visit their site for more information: Synlogic

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2019-01-04 04:34:43