CAMBRIDGE, Mass.,
Nov. 4, 2020 /PRNewswire/ -- Synlogic, Inc. (Nasdaq:
SYBX), a clinical stage company bringing the transformative
potential of synthetic biology to medicine, today announced it has
treated the first healthy volunteer in its Phase 1 study of
the investigational Synthetic Biotic medicine SYNB8802 for the
treatment of Enteric Hyperoxaluria (HOX).
"We are thrilled to be moving SYNB8802 into the clinic ahead of
schedule," said Aoife Brennan, M.B.
Ch.B., Synlogic's President and Chief Executive Officer.
"Leveraging our Synthetic Biotic platform allowed us to move
rapidly from candidate declaration to the initiation of the Phase 1
study in under nine months. Patients with dangerously high urinary
oxalate levels today have few options, and we will move this
program forward with a sense of urgency to meet their needs."
Enteric Hyperoxaluria is an acquired metabolic disorder caused
by increased absorption of dietary oxalate, which is present in
many healthy foods, making it almost impossible to control with
diet alone. Enteric Hyperoxaluria often occurs as a result of a
primary insult to the bowel, such as inflammatory bowel
disease, short bowel syndrome, or as a result of surgical
procedures such as Roux-en-Y bariatric weight-loss
surgery. Enteric Hyperoxaluria results in dangerously high
levels of urinary oxalate, which causes progressive kidney damage,
kidney stone formation, and nephrocalcinosis. There are no approved
treatment options.
SYNB8802 is an engineered non-pathogenic strain of E. coli
(Nissle), using Synlogic's Synthetic Biotic platform, designed to
consume oxalate in the GI tract and lower urinary oxalate levels,
potentially reducing kidney damage due to Enteric Hyperoxaluria.
SYNB8802 is administered orally.
Synlogic recently presented preclinical data on SYNB8802 at the
American Society of Nephrology's (ASN) Kidney Week 2020. Key
findings:
- SYNB8802 consumes oxalate and produces formate, a metabolite of
oxalate, in vitro.
- In both nonhuman primate and mouse models of acute
Hyperoxaluria, SYNB8802 significantly reduced oxalate levels at six
hours relative to vehicle alone.
- Proprietary in-silico simulations of predicted human exposure
suggest SYNB8802 has the potential to achieve between 20% and 50%
urinary oxalate lowering in patients at doses that have been well
tolerated in prior trials of Synthetic Biotic medicines.
"The Phase 1 clinical study will provide for a rapid proof of
concept read out by focusing on both an initial healthy volunteer
cohort as well as a cohort of patients with Enteric Hyperoxaluria
after Roux-n-Y gastric bypass surgery," said Richard Riese, M.D., Synlogic's Chief Medical
Officer. "This post-gastric bypass population provides an optimal
cohort to assess the ability of SYNB8802 to lower urinary oxalate.
We look forward to providing further updates as the study
progresses."
The Phase 1 clinical 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. SYNB8802
will be assessed for safety and tolerability, and the potential to
reduce urinary oxalate. Synlogic anticipates data from the
study will be available in 2021.
Learn more about Synlogic's programs and pipeline by visiting
https://www.synlogictx.com/.
About Synlogic
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.
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," "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 and availability of
clinical trial data. 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.
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SOURCE Synlogic, Inc.