CAMBRIDGE, Mass., Jan. 11, 2021 /PRNewswire/ -- Synlogic, Inc.
(Nasdaq: SYBX), a clinical stage company bringing the
transformative potential of synthetic biology to medicine, today
outlined significant clinical milestones for 2021 and provided an
overview of recent progress.
"With three programs in clinical trials, multiple proof of
concept opportunities, and a preclinical portfolio advancing
rapidly towards the clinic, Synlogic is poised for success with a
number of data readouts coming in 2021," said Aoife Brennan, M.B. Ch.B., Synlogic's President
and Chief Executive Officer. "2020 was a year we will not forget.
Despite the external challenges, the Synlogic team moved our
programs forward with grit and resilience. We enter 2021 with
momentum and the opportunity to truly see the potential of novel
Synthetic Biotic medicines to make a meaningful difference in
Synlogic anticipates clinical proof of concept data in 2021
across two metabolic programs, SYNB1618 for the treatment of
Phenylketonuria (PKU) and SYNB8802 for the treatment of Enteric
Hyperoxaluria, as well as continued advancement of SYNB1891 for the
treatment of solid tumors and lymphomas.
Execution Across Clinical Pipeline: Metabolic
- Progression of a proof of concept Phase 2 clinical trial of
SYNB1618 for the treatment of Phenylketonuria (PKU)
- SYNB1618 is an investigational drug composed of a Synthetic
Biotic medicine designed to consume phenylalanine (Phe) in the
gastrointestinal (GI) tract for the treatment of PKU in patients
regardless of age or disease type.
- A solid oral formulation of SYNB1618 has been shown to
metabolize Phe in the GI tract in a healthy volunteer study.
- The SynPheny-1 study evaluates plasma Phe lowering of SYNB1618
in adult PKU patients who do not benefit from, or do not tolerate,
existing therapies such as Kuvan or Palynziq.
- Synlogic anticipates data from SynPheny-1 will be available
- Progression of a Phase 1 clinical study of SYNB8802 for the
treatment of Enteric Hyperoxaluria
- SYNB8802 is an investigational drug composed of a Synthetic
Biotic medicine designed to consume oxalate in the GI tract and
lower urinary oxalate levels, potentially reducing kidney damage
due to Enteric Hyperoxaluria.
- In data presented at the American Society of Nephrology's (ASN)
2020 Kidney Week, SYNB8802 was shown to reduce urinary oxalate in
two animal models of Hyperoxaluria.
- The Phase 1 clinical study evaluates the safety, tolerability,
and potential for urinary oxalate lowering in healthy volunteers
- The study has two parts: Part A is a multiple ascending dose
study in healthy volunteers; Part B is a placebo controlled,
cross-over design study in patients with Enteric Hyperoxaluria
following Roux-n-Y gastric bypass surgery which provides an
opportunity to demonstrate proof of concept.
- Synlogic anticipates data from Part B of the study will be
Execution Across Clinical Pipeline: Immunomodulation
- Advancement of SYNB1891 into combination arm dosing with
PDL1 checkpoint inhibitor in ongoing Phase 1 study
- SYNB1891 is an investigational drug composed of an
intratumorally delivered Synthetic Biotic medicine designed to
produce a STING agonist and act as a dual innate immune activator
for the treatment of advanced solid tumors and lymphoma.
- SYNB1891 is currently being evaluated in a Phase 1 study that
has two parts:
- Part A is a monotherapy arm that has enrolled four dose cohorts
- A maximum tolerated dose has not been reached and dose
- Part A of the study has demonstrated target engagement and
activation of the STING pathway.
- Part B of the study will combine escalating dose levels of
SYNB1891 with a fixed dose of the PD-L1 checkpoint inhibitor
atezolizumab, to establish a recommended Phase 2 dose for the
- Synlogic anticipates additional data from cohorts in both arms
will be available in mid to late 2021.
- Synlogic continues to advance preclinical programs including
additional effectors for immune-oncology; immune regulation targets
for treatment of inflammatory bowel disease and other inflammatory
disorders; and additional undisclosed rare metabolic diseases.
- Further updates on these programs will be shared as they
advance towards the clinic.
2020 Corporate Milestones
- Synlogic strengthened leadership with the following
- Synlogic appointed Dr. David
Hava, Ph.D., as Chief Scientific Officer. Dr.
Hava brings over a decade of senior experience in research and
development to Synlogic, including deep academic expertise in
pillars of synthetic biology.
- Synlogic promoted Antoine 'Tony' Awad to Chief Operating
Officer. Mr. Awad brings over 15 years of experience in the
biotechnology and pharmaceutical industry with substantial
experience in the development and manufacturing of novel
therapeutics from pre-IND studies through global
- Synlogic appointed Michael
Heffernan, seasoned entrepreneur and biopharmaceutical
leader, and Dr. Michael Burgess,
physician scientist and expert in translational development, to its
board of directors.
- Synlogic and Ginkgo Bioworks advanced their long-term strategic
platform collaboration that provides expanded synthetic biology
capabilities to Synlogic.
- Ginkgo and Synlogic are collaborating on multiple efforts
including metabolic and immunomodulation programs, and assessment
of the potential application of Synthetic Biotics for vaccine
- Synlogic ended the third quarter of 2020 with $102.0 million in cash, cash equivalents and
short- and long-term investments and expects this will fund company
operations through 2022 under its current plan.
Learn more about Synlogic's programs and pipeline by visiting
Synlogic™ is bringing the
transformative potential of synthetic biology to medicine. With a
premiere synthetic biology platform that leverages a reproducible,
modular approach to microbial engineering, Synlogic designs
Synthetic Biotic medicines that target validated underlying biology
to treat disease in new ways. Synlogic's proprietary pipeline
includes Synthetic Biotics for the treatment of metabolic disorders
including Phenylketonuria (PKU) and Enteric Hyperoxaluria (HOX).
The company is also building a portfolio of partner-able assets in
immunology and oncology.
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," "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, 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; and the
expected timing of Synlogic's clinical trials including the Phase 1
study for SYNB1891 and SYNB8802 and the Phase 2 study of SYNB1618,
and availability of clinical trial data from that study and other
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 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 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 hereof.
SOURCE Synlogic, Inc.