SYNB-1934

Synlogic had already slimmed down its pipeline and workforce in 2022, leaving its future heavily reliant on labafenogene marselecobac’s success. Synlogic’s dreams have gone up in smoke on the news that a pivotal phase 3 study of its lead phenylketonuria (PKU) drug is on track to miss its primary endpoint. The Massachusetts-based biotech launched the 150-patient global Synpheny-3 trial of labafenogene marselecobac—which is designed to target and consume an amino acid called phenylalanine in the gastrointestinal tract—in June 2023. Top-line data had been expected in the first half of 2025. As recently as early January, CEO Aoife Brennan sounded optimistic about the trial. In a Jan. 4 look ahead, Brennan suggested that the data monitoring committee review of initial study data was set to be a “key milestone” that would help ensure 2024 was another “momentous” year for the company that could usher in an expansion of the trial into adolescent PKU patients. The committee’s review was indeed momentous for the company, but not in the way Brennan intended. Instead, they “indicated the trial was unlikely to meet its primary endpoint,” Synlogic revealed in a postmarket release Feb. 8. The decision was not based on concerns regarding the safety nor the tolerability of the drug, which is also known as SYNB1934, the biotech pointed out. As a result, the company will cease operations and lay off more than 90% of its workforce this month. The remaining employees will be involved with discontinuing the Synpheny-3 study across trial sites and assisting in a “strategic review” of the company “to enhance shareholder value.” Synlogic entered 2024 with cash, equivalents and short-term investments totaling $47.7 million. “It is with a heavy heart that we share this news, and our resulting decision to end Synpheny-3,” said Brennan, who will also be stepping down. “Based on the program’s progress and data to date, we had expected the study to demonstrate the potential for SYNB1934 to provide an important new treatment option for those affected by PKU.” The company had already slimmed down its pipeline and workforce in 2022, leaving its future heavily reliant on the success of labafenogene marselecobac. PTC Therapeutics appeared to have more success last year in a phase 3 trial in PKU. However, the design of the study meant analysts remained unsure about the strength of PTC’s hand and whether its drug sepiapterin could rival BioMarin’s approved PKU drug Kuvan. Since then, PTC’s approval application for sepiapterin has been brushed aside by the FDA, which demanded an additional mouse study.

CAMBRIDGE, Mass., June 08, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), the leading company advancing therapeutics based on synthetic biology, today reminded stockholders that it will hold its 2023 Annual General Meeting of Stockholders on Thursday, June 15, 2023 at 8:00 a.m. EST. The Annual Meeting will be held in a virtual meeting format only. Stockholders can access the meeting here, vote their shares electronically and submit their questions by entering their 16-digit control number found on the Notice of Internet Availability or the proxy card that they previously received via mail and email. Stockholders should allow ample time for check-in procedures before the meeting begins. Whether or not stockholders plan to virtually attend the Annual Meeting, Synlogic urges them to vote and submit their proxy in advance of the Annual Meeting by one of the methods described in the proxy materials for the Annual Meeting. About Synlogic Synlogic is a clinical-stage biotechnology company advancing novel, oral, non-systemically absorbed biotherapeutics to transform the care of serious diseases in need of new treatment options. The Company’s late-stage pipeline is focused on rare metabolic diseases, led by SYNB1934, currently being studied as a potential treatment for phenylketonuria (PKU) in Synpheny-3, a global, pivotal Phase 3 study. Additional product candidates address diseases including homocystinuria (HCU), enteric hyperoxaluria, gout, and cystinuria. This pipeline is fueled by the Synthetic Biotic platform, which applies precision genetic engineering to well-characterized probiotics. This enables Synlogic to create GI-restricted, oral medicines designed to consume or modify disease-specific metabolites – an approach well suited for PKU and HCU, both inborn errors of metabolism, as well as other disorders in which the disease–specific metabolites transit through the GI tract, providing validated targets for these Synthetic Biotics. Research activities include a partnership with Roche focused on inflammatory bowel disease (IBD), and a collaboration with Ginkgo Bioworks in synthetic biology, which has contributed to two pipeline programs to date. For more information, please visit or follow us on Twitter or LinkedIn. 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," “look forward,” "estimate," "expect," "intend," on track,” "plan," "predict," “prepare” 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 approach to Synthetic Biotics to develop therapeutics to address a wide range of diseases including: inborn errors of metabolism and inflammatory and immune disorders; our expectations about sufficiency of our existing cash balance; the future clinical development of Synthetic Biotics; the approach Synlogic is taking to discover and develop novel therapeutics using synthetic biology; and the expected timing of Synlogic's clinical trials of SYNB1934, SYNB1353, SYNB8802 and SYNB2081 and availability of clinical trial data. Actual results could differ materially from those contained in any forward-looking statements 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 U.S. Securities and Exchange Commission. 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. Media Contact: media@synlogictx.com Investor Relations:investor@synlogictx.com