ExeGi Pharma Reports Positive Phase 1b Results for EXE-346 Study

ExeGi Pharma LLC, a biotechnology enterprise specializing in live biotherapeutic and probiotic drug development, has announced promising results from the initial phase of its PROF study concerning the drug EXE-346. This study aims to evaluate the safety and efficacy of EXE-346 in individuals with ileal pouch-anal anastomosis (IPAA), a surgical procedure often performed on those with long-standing ulcerative colitis. The procedure, commonly known as J-pouch surgery, allows patients to avoid using a colostomy bag and pass stool normally. However, many patients experience frequent bowel movements exceeding ten per day, along with frequent nighttime awakenings.

The Phase 1b segment of the PROF study focused on assessing the impact of EXE-346 on excessive bowel movement frequency among IPAA patients. EXE-346 is a live biotherapeutic product containing a specific blend of eight probiotic bacterial strains at an extremely high potency. Participants consumed three trillion live probiotics daily over a four-week span. The results demonstrated a notable 18% reduction in daily bowel movement frequency, decreasing from an average of 13.09 to 10.69 movements per day. Furthermore, nighttime awakenings for bowel movements were reduced by 28%, from an average of 2.39 to 1.73 occurrences per night.

Importantly, the study reported no serious adverse events, underscoring the safety profile of EXE-346. These findings suggest that EXE-346 could potentially improve the quality of life for IPAA patients by significantly reducing both stool frequency and nighttime disruptions.

The study's Phase 2 trial is set to commence in January 2025 and will be conducted across eight clinical sites in the United States. This next phase will be a placebo-controlled trial to further evaluate the efficacy and safety of EXE-346 in a larger cohort of patients. Dr. Hans Herfarth, director of the University of North Carolina Multidisciplinary IBD Center, expressed optimism about the early results, highlighting the potential of EXE-346 to positively impact the lifestyles of IPAA patients.

ExeGi Pharma is known for its commitment to advancing microbiome science and developing innovative biotherapeutic and probiotic solutions to address unmet medical needs. The company prioritizes environmentally conscious practices, aiming to balance business operations with sustainable initiatives.

EXE-346 is currently under development to address the excessive stool frequency experienced by patients post-IPAA surgery. This product is formulated to meet biologic-grade cGMP standards, ensuring its high quality and efficacy.

ExeGi Pharma is headquartered in Rockville, Maryland, and continues to focus on the development and commercialization of live biotherapeutic and probiotic medicines. The PROF study is registered under the identifier NCT05938465, and further details can be found on clinicaltrials.gov.

As ExeGi Pharma progresses with the PROF study, the company's efforts to leverage scientific expertise in microbiome science hold promise for delivering novel, clinically supported treatments that address significant health challenges. The continued development of EXE-346 could offer a new therapeutic option for IPAA patients, enhancing their day-to-day lives and overall well-being.