Finch announces the initiation of a program to evaluate CP101 in the treatment of chronic hepatitis B
New CP101 Development Program for the Treatment of Chronic Hepatitis B
Finch also announced today the initiation of a program to evaluate CP101 for the treatment of chronic hepatitis B. This program builds on clinical evidence demonstrating hepatitis B virus e-antigen clearance following microbiome restoration, even among patients that have failed to achieve clearance following long-term antiviral therapy.1, 2 Finch intends to study if CP101 may restore the microbiome and support activation of an immune response in chronic hepatitis B patients. Research suggests that the microbiome can modulate the immune system, a mechanism targeted by approved therapies for hepatitis B such as pegylated interferon.
“The positive results from PRISM3 mark a pivotal moment for patients, Finch, and the entire microbiome field, as they demonstrate the ability to drive clinically meaningful outcomes with a microbiome drug. We plan to apply the same principles we used in CDI against the many other conditions linked to microbiome dysfunction,” said Mark Smith, PhD, Chief Executive Officer of Finch. “As an important next step towards this vision, we are announcing today a new development program for CP101 in the treatment of chronic hepatitis B.”
All of Finch’s investigational drugs are composed of microbial communities designed to restore the composition and function of the gut microbiome, the community of microbes that inhabit the gastrointestinal tract. While dysbiosis, or disruption, of this microbial community has been implicated in a wide range of diseases and numerous clinical studies have demonstrated promising clinical outcomes from investigational microbiota transplantation procedures, there are currently no FDA-approved drugs designed to restore the microbiome.3, 4
About CP101
CP101 is an investigational, oral microbiome drug that Finch is developing for conditions linked to microbiome dysfunction. With 42 billion doses of antibiotics administered globally each year, resulting in widespread damage to the microbiome, research suggests that microbiome dysfunction is associated with the pathogenesis of a wide range of serious medical conditions.5 CP101 is designed to deliver complete microbiome communities in orally administered, enteric release capsules. CP101 is rigorously tested and manufactured under Good Manufacturing Practices (GMP) conditions. CP101 is in late-stage clinical development for the prevention of recurrent C. difficile infection and will be evaluated as an investigational drug for the treatment of chronic hepatitis B.
The development of CP101 as a microbiome drug reflects the 2013 FDA policy that microbiome-based treatments are regulated as drugs.6作者: StephenW 时间: 2020-6-20 11:38