ExeGi Pharma LLC, a biotechnology company specializing in live biotherapeutic and probiotic medicines, has reported positive topline results from the Phase 1b portion of its PROF study. The study focused on EXE-346, a live biotherapeutic drug containing eight strains of live probiotic bacteria, aimed at patients with ileal pouch-anal anastomosis (IPAA, or "J-pouch") who suffer from excessive stool frequency.
- Clinical Findings: The open-label Phase 1b trial showed a 18% reduction in stool frequency (from 13.09 to 10.69 average daily bowel movements) and a 28% reduction in average nighttime awakenings (from 2.39 to 1.73 nightly) after four weeks of treatment. No serious adverse events were reported.
- Study Design: The PROF study is designed to investigate the safety and efficacy of EXE-346 in patients who have undergone the J-pouch procedure, a surgical intervention for long-term ulcerative colitis patients to avoid a colostomy bag. Despite the procedure, many patients experience more than 10 bowel movements per day and significant nighttime awakenings.
- Next Steps: The Phase 2 portion of the study, set to begin enrolling in January 2025, will be placebo-controlled and conducted at eight clinical sites across the US. This phase aims to further demonstrate the effectiveness of EXE-346 in improving the quality of life for IPAA patients.
Dr. Hans Herfarth, director of the University of North Carolina Multidisciplinary IBD Center, commented on the significance of these findings, stating, "We are pleased to see these favorable early results for the EXE-346 product in terms of both safety and efficacy. With this data, we can confidently move into the Phase 2 placebo-controlled portion of the study."
For more information on the PROF study, visit clinicaltrials.gov.
