Synlogic Ends Development of Experimental PKU Therapy, Cut 90 Percent of Staff as it Considers Company’s Future

Rare Daily Staff

Synlogic said it has ended a pivotal study of its lead experimental therapy to treat the metabolic condition phenylketonuria and cut 90 percent of its workforce as it weighs strategic alternatives.

The company, which was developing a new class of therapies using synthetic biology, said the decision to end Synpheny-3 is based on results of an internal review in advance of an upcoming independent Data Monitoring Committee 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 work with the Synpheny-3 clinical trial sites involved to implement the discontinuation.

“It is with a heavy heart that we share this news, and our resulting decision to end Synpheny-3. 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,” said Aoife Brennan, Synlogic president and CEO.

Synlogic in June had cut 21 percent of its staff as it initiated the phase 3 study in PKU in an effort to extend its cash runway until the second half of 2024. The decision to halt the current study and seek strategic alternatives reflects the difficult financing environment that has left investors intolerant of failure in an industry where failure is the norm.

Synlogic’s board will consider a full slate of options including a potential acquisition, merger, reverse merger, other business combination, sales of assets, dissolution, and other alternatives