When Seres Therapeutics reported positive late-stage data for its experimental microbiome treatment last month, scientists at Finch Therapeutics cheered the results from the rival company whose lead drug candidate addresses the same gut infection they aim to treat.
Positive data, no matter the source, helps the entire microbiome therapies field and paves the way for discussions with regulators, says Finch CEO Mark Smith. He adds that the data also help discussions with investors. Finch announced Thursday that it has raised $90 million to support its entire pipeline of microbiome therapies.
“It helps us in a lot of ways,” Smith says of the Seres (NASDAQ: MCRB) Phase 3 results. “It’s great to have our data and it’s great to have other data that’s supportive of this mechanism of action.”
Finch’s most advanced program, CP101, is a potential treatment for Clostridioides difficile (C. diff) infection. Antibiotic resistant C. diff bacteria can proliferate in the gut, leading to intestinal inflammation and diarrhea. In severe cases, the disease becomes fatal. Finch’s prospective fix is akin to a healthy gut microbiome in a pill. The company makes its drug by screening healthy donors and collecting stool samples, Smith says. Microbes are extracted from the samples and the bacteria are crystalized, then milled into a powder. That powder is put in a capsule designed to release its payload at the appropriate location in the patient’s gastrointestional tract.
In June, Finch released results from a 205-patient Phase 2 study showing that 74.5 percent of patients C. diff patients who received the study drug after antibiotics achieved a clinical cure after eight weeks. That outcome was achieved by 61.5 percent of those given a placebo. While Smith says the results were statistically significant, he adds that the FDA previously told the company that it would need positive data from two well-controlled studies before seeking regulatory approval.
Some of the new cash will support a second C. diff clinical trial, which Smith says will be similar to the Phase 2 study but perhaps slightly larger in enrollment. He adds, however, that given the unmet need for C. diff patients, there may be an opportunity to move faster and file for approval sooner based on data from the single Phase 2 study—which happens to be larger than Seres’s Phase 3 study and is, according to Finch, the largest placebo-controlled study to date testing an oral microbiome drug. Smith says Finch will meet with the regulator soon with the hope of hearing by the end of the year whether the company needs a second study to support a regulatory submission.
Finch and Seres both aim to treat C. diff by restoring the gut microbiome to a healthy state, but there are differences in their approaches. Finch aims to deliver to patients a therapy whose microbial composition is as close as possible to the entire spectrum of gut microbes. The Seres therapy is a curated collection of more than 50 specific bacteria. Similar to the way that two different bacterial strains can coexist rather than compete within the same microbiome community, the market might have a place for C. diff therapies from both Seres and Finch.
“We expect that Seres will be a really important option for late-stage disease,” Smith says. “We think we’ll have a great solution for patients earlier on in their disease.”
Now that Finch has positive clinical data for its C. diff drug, the company is preparing to apply the same approach to other diseases. The target is hepatitis B viral (HBV) infection. The company will test CP1010, comprised of the full spectrum of microbes from a healthy gut microbiome. But the goal of this cocktail of microbes is to activate an immune response that clears the virus. Smith says that this therapy has the potential to be part of a combination with existing or experimental antiviral drugs. A multi-pronged approach to the disease hits the virus in different ways and at different stages of the viral cycle, improving the chances for a better patient outcome, Smith says.
The autism spectrum disorder drug, FIN-211, is slightly different than CP101. It will be comprised of the full bacterial spectrum of a healthy gut microbiome. On top of that scaffold, Finch will add other organisms that are important for addressing gastrointestinal symptoms associated with the disorder. That’s the same approach taken with the ulcerative colitis and Crohn’s disease candidates being developed under a partnership with Takeda Pharmaceutical (NYSE: TAK).
The second C. diff study, if needed, is expected to start in the first half of 2021. Smith says it’s too early to say when data will be reported from that clinical trial. The HBV study is also slated for the first half of 2021, with data expected by the end of that year, Smith says. The autism study is expected to start in the second half of next year.
Finch’s new capital, a Series D round of funding, added investors Baupost Group, Humboldt Fund, MSD Capital, MSD Partners, Octave Group, and OMX Ventures. Earlier investors also participated, including Avenir Growth Capital, OCV Partners, Shumway Capital, SIG, SymBiosis, TPTF, and Willett Advisors.
Smith says that the cash should support Finch well into 2022. As for a pursuing an IPO, he says the company will explore a variety of options to meet its funding requirements.
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