Rare Disease Focused-Synlogic Pulls Plug On Lead Program, Shares Nosedive

Thursday, Synlogic Inc SYBX announced its decision to discontinue Synpheny-3, its ongoing pivotal study of labafenogene marselecobac (SYNB1934) as a potential treatment for phenylketonuria (PKU). 

The company expected data review from the Synpheny-3 study in PKU in the first half of 2024, with the potential to expand the study population to patients aged 12-17. Topline data from the Phase 3 study in PKU was expected in the first half of 2025.

Phenylketonuria is a rare inherited disorder that causes an amino acid called phenylalanine to build up in the body. Untreated phenylketonuria can lead to brain damage, intellectual disabilities, behavioral symptoms, or seizures.

As a result, Synlogic’s management and its Board of Directors have decided to evaluate strategic options for the company.

The decision to end Synpheny-3 is based on the results of an internal review before an upcoming independent Data Monitoring Committee (DMC) assessment, which indicated the trial was unlikely to meet its primary endpoint. 

The decision was not based on concerns regarding safety or tolerability. Synlogic will now work with the Synpheny-3 clinical trial sites to implement the discontinuation.

Synlogic’s Board of Directors plans to assess strategic options to enhance shareholder value, including acquisition, merger, reverse merger, other business combinations, sales of assets, dissolution, or other strategic transactions. 

As a result of this process, Synlogic will cease operations and reduce its workforce by more than 90%, retaining only certain employees to assist in the strategic review and the study’s discontinuation. 

The majority of impacted roles will end in February 2024. The company’s cash, cash equivalents, and short-term investments balance at December 31, 2023, was $47.7 million.

Dr. Aoife Brennan is also departing as President and Chief Executive Officer as part of the reduction and stepping down from the Board of Directors.

Price Action: SYBX shares are down 51.31% at $1.67 on the last check Friday.

Photo via Wikimedia Commons