- SYNB8802 Phase 1 study in patients with Enteric Hyperoxaluria ongoing; readout from Part B placebo-controlled crossover stage expected 2H 2021 -

Cambridge, Mass. (PR Newswire) June 10, 2021 – Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today presented on the development of the Synthetic Biotic™ Medicine SYNB8802 for the treatment of Enteric Hyperoxaluria during the American Society for Metabolic and Bariatric Surgery (ASMBS) annual meeting, being held virtually June 10-12, 2021.

The poster presentation, “Development of a Synthetic Biotic, SYNB8802, for the treatment of Enteric Hyperoxaluria,” will be available throughout the duration of the conference.

Enteric Hyperoxaluria is an acquired metabolic disorder caused by increased absorption of dietary oxalate, which is present in many healthy foods, and 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 surgery, which is one of the most common weight-loss surgeries in the United States.

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 oral investigational drug for the treatment of Enteric Hyperoxaluria composed of an engineered Synthetic Biotic designed to lower urinary oxalate levels by consuming oxalate in the GI tract, potentially reducing kidney damage due to Enteric Hyperoxaluria.

Synlogic is conducting a Phase 1 clinical study to evaluate the safety, tolerability, and potential for urinary oxalate lowering of SYNB8802 in healthy volunteers and patients with Enteric Hyperoxaluria following Roux-en-Y gastric bypass surgery. The company previously announced proof of mechanism data from Part A of an ongoing Phase 1a/b study in healthy volunteers that demonstrated a 28.6% decrease from baseline levels of urinary oxalate compared to placebo at the dose selected for Part B.

Part B of the study is a placebo-controlled crossover design in up to 20 patients with a history of Roux-en-Y gastric bypass surgery. The primary outcome for Part B is change from baseline in 24-hour urinary oxalate amount excreted with SYNB8802 versus placebo, and those data are expected in the second half of 2021. 

About SYNB8802
SYNB8802 is an investigational oral drug for the treatment of Enteric Hyperoxaluria composed of an engineered Synthetic Biotic designed to lower urinary oxalate levels by consuming oxalate in the GI tract, potentially reducing kidney damage due to Enteric Hyperoxaluria. Synlogic is conducting a Phase 1 clinical study to evaluate the safety, tolerability, and potential for urinary oxalate lowering of SYNB8802 in healthy volunteers and patients. 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-en-Y gastric bypass surgery which provides an opportunity to demonstrate proof of concept. SYNB8802 has achieved proof of mechanism in healthy volunteers during Part A of a Phase 1 study. Synlogic has initiated Part B of the study (NCT04629170) in patients.

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. The company is also building a portfolio of partner-able assets in immunology and oncology. Learn more about Synlogic's programs and pipeline by visiting https://www.synlogictx.com/.

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; our expectations about sufficiency of our existing cash balance; 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 of SYNB1618 and availability of clinical trial data including Phase 2 data of SYNB1618 for the treatment of PKU. 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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