Finch grabs a $53M round designed to take their ‘breakthrough’ microbiome treatment through a potentially pivotal trial
With a breakthrough designation in one hand and a fresh $53 million in venture backing in the other, Somerville, MA-based Finch Therapeutics is taking a shot at a one-trial pathway to a possible FDA OK for their new treatment for preventing recurrent C. difficile infections.
The funding brings their total raise for the microbiome company to $130 million, CEO Mark Smith tells me — enough money to pave a runway past the FDA approval they’ve sketched into the most optimistic version for their near-term future.
Smith says that based on their talks with regulators, the FDA would be satisfied if they could see high efficacy in this trial. If the p value comes in lower, it would serve as the first of two, with regulators looking for confirmation of the effect in a follow-up study.
Based on earlier results, Smith says a winning comparison would be around 80% efficacy in the treatment arm compared to a control arm effect — where patients just get antibiotics — in the 40% to 50% mark.
“We were really pleased with the outcome of the conversation,” says the CEO. “It’s a high bar for the effect size we’re looking for.”
It’s no sure thing. Finch — who struck a deal to collaborate with Takeda on IBD — is working with data they gathered in a small study, where they saw an 88% rate of efficacy. Efficacy was defined as two months with no recurrence of the C. diff. That persuaded them to see if they could blaze a path forward with a single pivotal study, which would take them past a number of rivals also focused on the same target.
That effect, though, is “right in line” with fecal transplantation. So why not continue with the fecal material?
In part because it involves a procedure, Smith replies, which a therapy would cut out of the equation. Second, if they can land an FDA approval, regulators will likely require the approved therapy over fecal transplantation, which is still experimental. In addition, the FDA is wary about fecal transplantation, recently noting a death due to an infection from a multi-drug resistant organism picked up in one procedure.
Smith has some insights into the fecal transplantation world garnered from a front-row seat. He’s been building Finch Therapeutics on the foundation provided by OpenBiome, a fecal transplant company he founded. And he’s been engineering new products based on that experience with the gut.
And they’ve been moving fast, picking up their lead drug CP101 in a merger with Crestovo — which brought in additional support from Chris Shumway of Shumway Capital — executing a $36 million C round a little more than a year ago.
Their timeline takes them to a trial readout in H1 2020.
Success here would also accelerate their work on autism, which follows up on some evidence that fecal transplantation has an effect here as well.
New investors including OCV Partners, Susquehanna International Group and Trans-Pacific Technology Fund jumped in to the syndicate, alongside existing investors Avenir Growth Capital, Morgan Noble, Shumway Capital, and Willett Advisors.