Close to a year after Seres declared that it had jumped back on track after a troubling setback with its lead microbiome drug for Clostridium difficile infections, a dark horse in the pack is challenging it for the lead in the emerging field.
Four months after merging with Crestovo, Finch Therapeutics has raised $36 million in Series B money to hustle ahead with a mid-stage study of CP101 that got underway last summer. The “full spectrum microbiota” product was the main attraction for the merger, Finch CEO Mark Smith tells me, and replaced their own rival therapy in the pipeline.
The combination of the two biotechs also came with new support from Crestovo supporter Chris Shumway of Shumway Capital, who helped bring the syndicate together. Willett Advisors, Morgan Noble and Avenir Growth Capital all stepped in for the round, which brings Finch’s total haul to $77 million.
Crestovo’s academic collaborators, Alexander Khoruts and Michael Sadowsky, ran an open-label study in 49 patients that they deemed a success, with 88% of the patients not seeing a recurrence of C diff over two months. The Cambridge, MA-based company then started to recruit 240 patients for a pivotal trial of the therapy.
Smith says that the FDA has also come through with fast track designation — not a high hurdle, typically, but he’s happy to have it. And after talks with regulators, he says, they’re dropping the low-dose arm that had been planned, focusing on two doses in a study that will now be capped with 200 patients.
That is enough to get what the CEO says is potentially registrational data, though the FDA will have the final say in whether they need to do a mirror study to confirm their results before or after an approval.
“We think that this data we’re generating in Phase II could support a BLA,” Smith tells me. “We think it’s the first product to really capture what works well with fecal transplantation.”
And it’s an oral dose, which Smith believes is another added advantage for the company, partnered with Takeda. He’s been building the biotech on the foundation provided by OpenBiome, a fecal transplant company he founded.
C diff, though, is the big initial focus in the microbiome field, and Finch will have to beat out some serious rivals.
Seres was hammered hard back in 2016, after the company said its Phase II study of SER-109 failed to demonstrate efficacy in reducing the recurrence of Clostridium difficile infection. The therapy barely separated from a placebo, crushing the biotech’s share price. But they rallied, putting together a new “pivotal worthy” study with a dose that is 10 times as high as what it started out with.
Finch will need to get great results to establish a lead here. Smith isn’t saying just how long it will be before the data read out. But he does note that it shouldn’t be too long now, with the company focused on building out the manufacturing needed to back up a product.
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 31,600+ biopharma pros who read Endpoints News by email every day.Free Subscription