Synlogic Obtains FDA Fast Track Designation for SYNB1353 for the Treatment of Homocystinuria (HCU)

CAMBRIDGE, Mass., Aug. 23, 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, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to SYNB1353 for the potential treatment of homocystinuria (HCU).

The FDA’s Fast Track process is designed to facilitate the development and expedite the review of drugs to treat serious conditions and address an unmet medical need. To be eligible, available clinical and non-clinical data must demonstrate significant therapeutic potential. Benefits of Fast Track designation include opportunities for frequent meetings with the FDA to discuss trial design, development plans, and data needed to support drug approval, as well as the ability to submit a registration for approval on a rolling basis and eligibility for priority review, if relevant criteria are met. SYNB1353, an orally administered, non-systemically absorbed drug candidate designed to consume methionine to reduce homocysteine ​​levels, is currently being evaluated in a Phase 1 study in healthy volunteers.

“FDA’s Fast Track designation reinforces our belief in the urgent need for new treatments for HCU as well as the promising non-clinical data we have generated in the program to date,” said Aoife Brennan, MB Ch.B. , Synlogic President and CEO. “We look forward to sharing additional data from the program later this year.”

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 bacteria E. coli Nissle 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 Bioworks 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 a research collaboration with Roche on the discovery of a new synthetic biotic for the treatment of inflammatory bowel disease. Synlogic has also developed two drug candidates in a research collaboration with Ginkgo Bioworks: SYNB1353, designed to consume methionine for the potential treatment of UHC, and SYNB2081, designed to reduce uric acid for the potential treatment for gout. 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 safety, efficacy, 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 of the adequacy of our existing cash balance; future clinical development of Synthetic Biotics, including SYNB2081; 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 risks identified under “Risk Factors” in Synlogic’s filings with the United States Securities and Exchange Commission. 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 a change of opinion. 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.






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