Synlogic Initiates Phase 1 Study of SYNB1353 for the Treatment of Homocystinuria (HCU)

Synlogic, Inc.

Data expected in H2 2022 brings Synlogic to three clinical reads this year

Third candidate in less than two years to enter the clinic; Mirrors the productivity of the Synthetic Biotic platform

CAMBRIDGE, Mass., July 12 10, 2022 (GLOBE NEWSWIRE) — Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing drugs for metabolic and immunological diseases through its proprietary synthetic biology approach, announced today that it dosed its first healthy volunteer in its Phase 1 study of experimental oral therapy SYNB1353 designed to consume methionine for the potential treatment of homocystinuria (HCU).

“We are excited to continue to advance our program portfolio with today’s announcement, a notable milestone as we continue toward three clinical readouts expected in 2022, and a reflection of the productivity of the Synthetic Biotic platform.” , said Aoife Brennan, MB Ch. B., President and CEO of Synlogic. “Given the particularly great need for new treatment options for people living with HCU, we look forward to sharing data from this study by the end of this year.”

SYNB1353 is a drug candidate designed to provide a safe, orally administered, non-systemically absorbed treatment for consuming methionine to reduce homocysteine ​​levels in patients with UHC, thereby reducing the risk of serious and debilitating complications. UHC is an inherited disease characterized by elevated homocysteine ​​levels and risks such as thromboembolism, lens dislocation, skeletal abnormalities, developmental delay and intellectual disability. Treatment options for UHC are currently limited due to their effectiveness and tolerability. SYNB1353 is a modified strain of the probiotic bacterium E. coli Nissle (EcN) that consumes methionine in the gastrointestinal tract, preventing the absorption of methionine and its conversion to homocysteine ​​in plasma. It is the first drug candidate developed through a research collaboration between Synlogic and Ginkgo and the first investigational drug developed on Ginkgo’s platform to enter the clinic. In 2021, Synlogic shared preclinical data for SYNB1353 that demonstrated the decrease in blood homocysteine ​​levels in non-human primates and mouse models. Synlogic expects to share results from the Phase 1 study of SYNB1353 in healthy volunteers by the end of 2022.

About Synlogic

Synlogic is a clinical-stage biotechnology company that develops drugs through its proprietary approach to synthetic biology. Synlogic’s pipeline includes its lead program in phenylketonuria (PKU), which has demonstrated proof of concept with plans to start a pivotal Phase 3 study in the first half of 2023, and additional new drug candidates designed to treat homocystinuria (HCU) and enteric hyperoxaluria. The rapid advancement of these potential biotherapies, called synthetic biotics, has been made possible by Synlogic’s reproducible, target-specific drug design. Synlogic uses programmable and precise genetic engineering of well-characterized probiotics to exert localized activity for therapeutic purposes, with an emphasis on metabolic and immunological diseases. In addition to its clinical programs, Synlogic has research collaborations with Roche on the discovery of a new synthetic biotic for the treatment of inflammatory bowel disease and with Ginkgo Bioworks on additional undisclosed preclinical assets. For more information, visit www.synlogictx.com.

About SYNB1353

SYNB1353 is a novel, orally-administered, non-systemically absorbed drug candidate designed to consume methionine in the gastrointestinal tract, thereby lowering homocysteine ​​levels in patients with homocystinuria (HCU). UHC is an inherited disease characterized by elevated homocysteine ​​levels and risks such as thromboembolism, lens dislocation, skeletal abnormalities, developmental delay and intellectual disability. Treatment options for UHC are currently limited due to their effectiveness and tolerability. Synlogic owns worldwide development and commercialization rights to SYNB1353 and is expected to release Phase 1 data in healthy volunteers in the second half of 2022.

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 fact, included in this press release regarding strategy, future operations, clinical development plans, future financial condition, future revenues, projected expenses, outlook, plans and objectives of management are forward-looking statements. In addition, when used in this press release, the words “may”, “could”, “should”, “anticipate”, “believe”, “look forward to”, “believe”, “expect to”, “intend”, “on track”, “plan”, “predict” and similar expressions and variations thereof, with respect 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 approach to synthetic biotics to develop therapies to treat a wide range of diseases, including: inborn errors of metabolism and inflammatory and immune disorders; our expectations regarding the adequacy of our existing cash balance; the future clinical development of Synthetic Biotics; Synlogic’s approach to discovering and developing new therapies using synthetic biology; and the anticipated timing of Synlogic’s clinical trials of SYNB1618, SYNB1934, SYNB1353 and SYNB8802 and the availability of clinical trial data. Actual results could differ materially from those contained in forward-looking statements due to a variety of factors, including: uncertainties inherent in the clinical and preclinical development process; Synlogic’s ability to protect its intellectual property rights; and legislative, regulatory, political and economic developments, as well as the 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 beliefs regarding future events. Synlogic anticipates that subsequent events and developments will cause our views to change. However, while Synlogic may choose to update these forward-looking statements in the future, Synlogic specifically disclaims any obligation to do so. These forward-looking statements should not be taken to represent the views of Synlogic as of any date subsequent to the date hereof.

Media Contact:
Bill Berry
Berry & Company Public Relations
212-253-8881; [email protected]

Investor contacts:
Andrew Funderbury
Kendall Investor Relations
617-914-0008; [email protected]

About Antoine L. Cassell

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