“We are excited by the topline results and look forward to engaging with FDA on the next steps to bring CP101 through the regulatory process.”ĬP101 builds on the significant body of evidence that microbiome restoration via microbiota transplantation procedures can prevent recurrent CDI. Intervening early in the cycle of the disease is crucial to preventing the debilitating effects of recurrent CDI, which is why we made it a priority to include patients experiencing their first recurrence of CDI in PRISM3,” said Zain Kassam, MD, MPH, Chief Medical Officer at Finch. “Recurrent CDI has a life-changing impact on patients, robbing them of their health and well-being.
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Finch plans to present the full results of the study at an upcoming medical conference.
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After the eight-week period evaluating the primary efficacy endpoint, patients in the trial are being followed for an additional 16 weeks for additional safety and efficacy endpoints. The primary endpoint of the trial is defined as the absence of CDI through eight weeks following treatment. The study included patients diagnosed with CDI by polymerase chain reaction (PCR) or toxin enzyme immunoassay (EIA) laboratory testing, reflecting real-world clinical practices for detecting CDI. Participants in the trial included patients experiencing their first recurrence of CDI, enabling the evaluation of CP101 as an early intervention in the course of this debilitating and life-threatening disease, enhancing the clinical relevance of the trial. PRISM3 participants received a one-time oral administration of CP101 or placebo, following a course of standard-of-care CDI antibiotic therapy, which all patients received. PRISM3 Trial and CP101 Oral Administration Advance the Microbiome Field PRISM3 is expected to provide pivotal data to support the approval of CP101 for the prevention of recurrent CDI. Breakthrough Therapy designation provides expedited review and access to collaborate with the FDA on rapid development of CP101. Food and Drug Administration (FDA) for the prevention of recurrent CDI. “This validates the approach of microbiome restoration and is a critical milestone for the field, opening the potential to develop this class of therapy for many other conditions arising from disruption of the microbiome.”ĬP101 is an investigational, potentially first-in-class oral microbiome drug that has been granted Fast Track designation and Breakthrough Therapy designation by the U.S. difficile infections on patients’ lives,” said Jessica Allegretti, MD, MPH, Principal Investigator in the PRISM3 clinical trial at Brigham and Women’s Hospital in Boston. “These results are very encouraging and show that CP101 has the potential to fulfill the need for an oral drug that breaks the cycle of CDI recurrence, preventing the devastating effects of recurrent C. CP101 is the first oral microbiome drug to meet its primary endpoint in a pivotal trial. and Canada, representing the largest placebo-controlled trial to date of an oral microbiome drug. PRISM3 randomized 206 patients with recurrent CDI at 51 sites across the U.S. CP101 was well-tolerated in the study at eight weeks post treatment, with no treatment-related serious adverse events. In the PRISM3 trial, CP101 met the primary efficacy endpoint, with 74.5% of recurrent CDI patients who received a single administration of CP101 achieving a sustained clinical cure through week eight, a statistically significant improvement in comparison to 61.5% of patients in the control group who received standard-of-care antibiotic therapy alone (p < 0.05). (“Finch”), a clinical-stage microbiome drug development company, announced today positive topline results from PRISM3, its multi-center, randomized, double-blind, placebo-controlled Phase 2 trial of CP101, an investigational oral microbiome drug, for the prevention of recurrent C. SOMERVILLE, Mass.-( BUSINESS WIRE)-Finch Therapeutics Group, Inc.
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