FDA lifts hold on Finch’s microbiome crapsule, as company looks to right ship
Finch Therapeutics’ lead program may fly again.
The microbiome company announced Thursday that the FDA lifted a two-month hold on clinical trials for its experimental treatment for recurrent C. diff, a potentially fatal bacterial infection. Although the company still has to take several steps before it can resume its pivotal study, the lift removes an unusual pandemic-related hurdle for Finch as the biotech looks to get its first therapy over the finish line and stabilize a precarious financial situation.
Finch is one of several companies attempting to develop treatments for C. diff and other diseases by giving patients tablets — sometimes jokingly or not-so-jokingly referred to as crapsules — containing bacteria strains extracted from donor stool. In theory, the new strains will recolonize the patients’ gut, creating an environment where C. diff can’t take hold.
In a pandemic, though, the FDA feared that stool samples might be able to transmit SARS-CoV-2 between patients. (Other serious infections have been passed through fecal transplant, a closely related but distinct procedure.)
In March 2020, the agency prohibited Finch from dosing trial patients with drug derived from any donor samples taken after Dec. 1, 2019, but Finch said they were able to continue trials with samples banked before that date. Beginning in early 2021, the company says it was able to start getting new donors again, first because its contract manufacturer employed SARS-CoV-2 screening methods and then because it bought out some of the manufacturer’s technology and employed the same screening methods.
In March 2022, though, the company said the agency raised questions about those procedures and paused enrollment in a Phase III trial. Finch now says those concerns have been resolved after “a review of information Finch provided related to its SARS-CoV-2 screening procedures and associated informed consent language.”
The hold couldn’t come sooner for Finch. Although the company showed some of the first positive results in a randomized microbiome trial in 2020, it has come on hard times as the larger biotech market has taken a downturn.
Earlier this month, the company laid off 37 employees, or 20% of its workforce. Its stock $FNCH has fallen 85% over the past year, from $14.04 to $2.10 at the closing bell Thursday. It is up $2.91 per market on the news.
It also sidelined a program in hepatitis B to reserve cash.
The company’s future will depend on the Phase III results from the trial, although that won’t get off the ground just yet. Although Finch says the agency has lifted the hold, it hasn’t done everything the FDA wants.
The company still needs to “complete certain manufacturing activities and quality system updates related to the recently resolved clinical hold,” it said. It also needs to submit to the FDA a “validation package” for one of its “release tests” and it needs to change the algorithms used to monitor whether a patient has a recurrent C. diff infection.