Finch clips wings of hepatitis B program, hitting pause on clinical plan to focus on C. diff and autism

 Finch Therapeutics has joined the ranks of biotechs that are narrowing their focus. With its lead program under clinical hold, the microbiome specialist has pulled out of a planned study in chronic hepatitis B.

Development of CP101 in chronic hepatitis B is on pause after a strategic review persuaded Finch to preserve its cash for programs targeting recurrent Clostridium difficile infection and autism. Finch made the decision to focus on those two internal programs, plus partnered work with Takeda on inflammatory bowel disease, to make the best use of the $133.5 million it had in the bank as of the end of 2021.

The removal of hepatitis B from the list of priority programs at Finch marks a sharp shift in strategy. Back in August, Finch signaled its intent to expand a planned phase 1b in hepatitis B, doubling the number of cohorts to enhance its ability to detect a signal among key exploratory endpoints.

At that time, Finch planned to start the phase 1b trial, RECLAIM, early in 2022. The timeline would have put Finch on track to deliver an initial safety readout in the first half of 2022 and follow up with top-line results in multiple cohorts by the end of the year. Those targets are now delayed indefinitely. 

Finch still plans to advance its autism spectrum disorder prospect, FIN-211, but its progress into the clinic has hit a delay. One month ago, the FDA put Finch’s phase 3 trial of CP101 in recurrent C. difficile on hold as it sought more information about SARS-CoV-2 donor screening protocols for the microbiome therapy. 

The autism candidate is different, but, as it also uses donor-derived components, Finch has determined it will be affected by the FDA’s request. Finch needs to complete additional manufacturing activities for components of FIN-211 and expects at least a one-quarter delay to the start of the phase 1b trial. 

Enrollment in the phase 3 C. difficile trial remains paused, but Finch is working toward the resolution of the impasse. Since disclosing the clinical hold in early March, Finch has sent a complete response to the agency and received additional feedback. Again, Finch expects at least a one-quarter delay.

Each delay moves Finch closer to the end of its cash runway. Finch, which has seen its share price fall 50% to $5 this year, expects its cash reserves to last through to mid-2023. 

https://www.fiercebiotech.com/biotech/finch-clips-wings-hepatitis-b-program-hitting-pause-clinical-plan-focus-c-diff-and-autism