Synlogic Receives Orphan Drug Designation from FDA for SYNB1934 for the Treatment of Phenylketonuria

Synlogic Co., Ltd.

Synlogic Co., Ltd.

CAMBRIDGE, Mass., May 9, 2023 (GLOBE NEWSWIRE) — Synlogic, Inc. (Nasdaq: SYBX), a leading company advancing synthetic biology-based therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has ) announced that it has licensed orphans. The drug designation (ODD) was added to his SYNB1934 as a treatment for phenylketonuria (PKU).

Synlogic President and CEO Aoife Brennan MB Ch.B. “This designation also comes at a pivotal time as he prepares to begin a Phase 3 trial of his PKU, Synpheny-3, in the first half of this year.”

ODD is granted by the FDA to drugs or biologics intended to treat rare diseases or conditions. This generally affects her less than 200,000 individuals in the United States. Potential market exclusivity for 7 years after approval.

SYNB1934 has also received Rare Pediatric Disease Designation (RPDD) from the FDA and Orphan Designation from the European Medicines Agency (EMA).

About SYNB1934

SYNB1934 is an orally administered, non-systemically absorbed drug candidate being investigated as a potential biotherapeutic agent for phenylketonuria (PKU). PKU is a rare inherited metabolic disorder caused by an inborn error of metabolism that impairs the breakdown of phenylalanine (Phe), an amino acid found in all protein-containing foods. Treatment options for PKU are currently limited and the majority of patients with PKU either require treatment or do not respond well to treatment. Synlogic uses genetic engineering of a well-characterized probiotic to lower her Phe levels in people with PKU by consuming her Phe in the gastrointestinal (GI) tract. designed the SYNB1934. Escherichia coli Nissl. Findings to date support the potential for oral, effective, safe, convenient, and flexible treatment options for PKU. SYNB1934 has received rare pediatric and orphan drug designation from the U.S. Food and Drug Administration (FDA) and orphan drug designation from the European Medicines Agency (EMA).

About Synlogic

Synlogic is a leading company advancing therapeutics based on synthetic biology. Synlogic’s pipeline includes a lead program in phenylketonuria (PKU), a proof-of-concept with plans to initiate a pivotal Phase 3 study in the first half of 2023, homocystinuria ( HCU), an additional drug candidate designed to treat enteric hyperoxaluria. and gout. Rapid advances in these potential biotherapeutics, called synthetic biotics, are made possible by Synlogic’s reproducible, target-specific drug design. Synlogic uses programmable, precision genetic engineering of well-characterized probiotics to exert local activity for therapeutic benefit, with a focus on metabolic and immune diseases. In addition to its clinical program, Synlogic is collaborating with Roche on the discovery of new synthetic biologics for the treatment of inflammatory bowel disease (IBD). Through a research collaboration with Ginkgo Bioworks, Synlogic has developed SYNB1353, designed to consume methionine for the potential treatment of HCU, and SYNB2081, designed to lower uric acid for the potential treatment of gout. also developed two of his drug candidates for For more information, please visit

Forward-Looking Statements

This press release contains “forward-looking statements” that are subject to material risks and uncertainties for purposes of safe harbor as defined by the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are contained in this press release of the strategy. , future operations, clinical development plans, future financial condition, future revenues, projected costs, outlook, management’s plans and objectives are forward-looking statements. Further, when used or used in this press release, the terms “could”, “could”, “should”, “anticipate”, “believe”, “expect” ”, “estimate”, “expect”, “intend”, “on track”, “plan”, “estimate”, “prepared” and similar expressions and variations thereof in connection with Synlogic are forward-looking statements. may identify. Examples of forward-looking statements include, but are not limited to, statements regarding the potential for Synlogic’s approach to synthetic biotics to develop therapeutics to address a wide range of diseases. Expectations about the sufficiency of existing cash balances. Future clinical development of synthetic biotics; the approach Synlogic is taking to discover and develop new therapeutics using synthetic biology. Synlogic’s SYNB1934, SYNB1353, SYNB8802, SYNB2081 clinical trial timelines and clinical trial data availability. Actual results may differ materially from those contained in forward-looking statements as a result of a variety of factors, including: Ability to protect Synlogic’s intellectual property rights. Legislative, regulatory, political and economic developments and risks identified under the heading “Risk Factors” in Synlogic’s filings with the U.S. Securities and Exchange Commission. The forward-looking statements contained in this press release reflect Synlogic’s current views regarding future events. Synlogic expects its views to change as a result of subsequent events and developments. However, Synlogic may choose to update these forward-looking statements in the future, but Synlogic expressly disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the views of Synlogic as of any date after the date hereof.

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