Finch’s First Microbial Cocktail Treating Clostridium Infection Registers Positive Results
By Ruchi Jhonsa, Ph.D.
Just a month after Rebiotix announced positive preliminary data for its microbiota-based therapy treating recurrent C. diff infection, Finch Therapeutics is close behind with its oral microbiome drug eliminating C. diff population in the gut.
Microbial communities are localized on all the surfaces of the human body, but in the gut, bacterial species are present in higher densities. There are over 1000 different species of bacteria in the gut, which localize on the gut wall and support various bodily functions. Normally, these different bacterial species maintain decorum in the gut, which ensures no one takes over the other. However, when the balance is disturbed, mostly during antibiotic treatment, Clostridium difficile takes over the healthy bacterial population and causes infection leading to diarrhea and, in severe cases, death. According to the CDC, there is a rising incidence of recurring CDI cases on top of the rise in the new CDI infections. Approximately 500,000 individuals suffer from CDI each year in the US, and of the total, 45% experience recurrence of the infection after one round of antibiotic treatment.
The standard of care usually eliminates bacterial growth with more antibiotics, which, although it removes the infection-causing bacteria, disturbs the entire gut microbiota resulting in recurrence of the infection. With microbiota therapy, Finch is trying to solve the underlying problem, which is to restore the natural bacterial bloom lost during antibiotic treatment. While disruption of the microbial community is common in a wide range of diseases, there are no FDA approved drugs to treat these conditions using microbiota at the moment. The company’s lead program, CP101, an investigational microbial therapy, received Fast Track and Breakthrough Therapy designation from the USFDA for the prevention of C. diff infection.
PRISM 3 Trial
This randomized, placebo-controlled study conducted at 51 sites across the US and Canada with 206 patients determined whether microbial cocktail, CP101 could achieve a clinical cure i.e., absence of the C. diff infection through eight weeks in comparison to the standard of care alone. Participants in the trial included patients experiencing their first recurrence of the infection. They received a one-time oral administration of the drug or placebo after they had undergone a course of the standard of care antibiotic therapy. After eight weeks, C. diff bacterial load was determined along with its safety profile.
What is in the future for Finch?
Besides pursuing C. diff infection, the company is also evaluating CP101 for the treatment of chronic hepatitis. Although the indication isn’t directly related to gut microbial disturbance, it has been demonstrated that microbial restoration clears the hepatitis virus even in patients that have failed to achieve clearance after long-term antiviral therapy. Finch believes that this is mostly due to the effect of gut microbiota on boosting the immune system and is now trying to work out whether CP101 uses the same mechanism to clear viral infections.
Besides CP101, which represents “full-spectrum” (FSM) of donor-derived microbiota, Finch is also working on developing a “rationally selected” (RSM) collection of microbiota using its Human first platform that will benefit patients with certain conditions. For this, the company is partnering with Takeda Pharmaceuticals for addressing inflammatory conditions, ulcerative colitis, and Crohn’s disease. Finch is also working on a strategy that combines full spectrum and rationally designed methods with donor-derived mix strains to address gastrointestinal and behavioral symptoms in children with Autism.