Synlogic shutters operations after ending phenylketonuria trial
08 Feb 2024
Phase 3Phase 2Microbial therapyClinical Trial Failure
Shares in Synlogic cratered Thursday, sinking as much as 55% in after-hours trade following the company's decision to pull the plug on a Phase III study of its lead asset labafenogene marselecobac (SYNB1934) as a potential treatment for phenylketonuria.
The company is now weighing a menu of options for its future, including a possible acquisition, merger, sale of assets or dissolution, but in the meantime is closing down operations, and laying off almost all of its staff. The majority of impacted positions will end this month. About 10% of workers will be retained to help with its strategic review and assist in the discontinuation of the Synpheny-3 study.
Synpheny-3 got under way last June, and Synlogic noted at the time that it incorporated feedback regarding its design from global regulatory agencies, including the FDA. The global study was expected to recruit approximately 150 patients with baseline plasma phenylalanine (Phe) levels of >360 μM, and tested three doses. The primary endpoint was change in plasma Phe levels.
Trial unlikely to succeed
However, an internal review conducted in advance of an upcoming independent data monitoring committee (DMC) assessment, indicated the trial was unlikely to meet its primary endpoint. Synlogic said its decision was not based on any safety or tolerability concerns. Labafenogene marselecobac is a synthetic biotic designed from natural probiotic single strain bacteria engineered using Synlogic's synthetic biology and microbiome platform.
The company's other pipeline projects include SYNB1353 and SYNB8802, both at the cusp of entering Phase II for classical homocystinuria and enteric hyperoxaluria, respectively, according to its website. It was also working on the preclinical gout treatment SYNB2081, and two other undisclosed candidates for cystinuria and inflammatory bowel disease.
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