FDA slaps hold on Finch's microbiome C. difficile treatment, as biotech blames Covid-19 and old manufacturer
Drugmakers working on treatments for C. difficile infections are having a bad week.
Just one day after Pfizer reported its C. difficile vaccine candidate did not hit the primary endpoint in a Phase III study, Finch Therapeutics is finding itself in a similar position. The biotech said Tuesday its microbiome treatment for the infection was placed on clinical hold by the FDA last week, with regulators seeking more info on Finch’s screening protocols.
News of the hold sent Finch shares $FNCH down about 14% after Monday’s closing bell.
Like Pfizer, Finch blamed the Covid-19 pandemic for its troubles, pointing to an FDA safety alert from March 2020 over the potential SARS-CoV-2 transmission risk through microbiome treatments. In conjunction with the alert, regulators put Finch’s IND and then-manufacturer on partial hold so as to add Covid-19 testing to any donor material received after Dec. 1, 2019.
As Finch tells it, researchers were able to continue dosing in an ongoing Phase II trial, using donor samples before that date. In January 2021, the manufacturer, OpenBiome, was released from clinical hold and Finch then bought the manufacturing tech two months later. In November, Finch began dosing participants in a Phase III trial using the same screening methods it says were used by OpenBiome and subsequently acquired.
But the FDA reached out in January, ostensibly with some questions, and sent the clinical hold notice on Feb. 24. As a result, Finch is pausing enrollment in that Phase III study, its second pivotal study looking to evaluate the microbiome treatment.
Finch did note that some patients were dosed in this pivotal study while the hold was in effect. The company said in a press release it is conducting a review of the matter. Endpoints News has reached out for comment and will update accordingly.
Previously, the therapy dubbed CP101 passed its first Phase III test with nominal statistical significance, hitting the primary endpoint of a sustained clinical cure through week 8. Between treatment and placebo, Finch reported a 33.8% relative risk reduction, good for a p-value of p=0.0488.
The treatment remained durable too, the company said, noting 73.5% of participants sustained the cure effects through 24 weeks, compared to 59.4% on placebo. Finch’s therapy proved more statistically significant here, notching a p-value of p=0.0347.
Where Finch goes from here is not yet clear, as the company said it’s still evaluating how long a delay could be in its topline readout. Finch is also testing CP101 in chronic hepatitis B, with studies currently in the preclinical phase, and it’s also not clear how these studies might be impacted.
Though Finch is in for some choppy waters ahead, it’s arguably in a more favorable position than Pfizer or Summit Therapeutics, which is developing an antibiotic for C. difficile infections. Neither Pfizer nor Summit recorded statistically significant Phase III results and Finch already has one under its belt.