ExeGi Pharma Positive Topline Results in EXE-346 PROF Phase 1b Study

• PROF study demonstrates safety of EXE-346 drug product in pouch anastomosis patients at 3,000 billion live probiotic consumption per day for four weeks
• Excessive bowel movement (BM) frequency was reduced at four weeks by 18% over baseline values

ROCKVILLE, Md., Dec. 17, 2024 /PRNewswire/ -- ExeGi Pharma LLC, a company focused on developing live biotherapeutic ("LBP") drugs and probiotics, announced positive topline results in the Phase 1b portion of its PROF study. The PROF study is designed to investigate EXE-346 in patients with an ileal pouch-anal anastomosis (IPAA, or "J-pouch") who experience excessive stool frequency. EXE-346 is a live biotherapeutic drug that contains a fixed proportion of eight strains of live probiotic bacteria in an extremely high potency.  

An ileal pouch-anal anastomosis is a surgical procedure typically performed in patients with long-term ulcerative colitis. The J-pouch procedure helps patients to avoid having a colostomy bag, allowing them to pass stool normally; however, many patients with a J-pouch experience extreme stool frequency of more than 10 bowel movements per day. Patients also tend to experience significant nighttime awakenings to have bowel movements — sometimes more than four times per night. The EXE-346 PROF study seeks to establish the safety profile of the drug and investigate the efficacy of the product in reducing this stool frequency and nighttime awakenings.

Clinical findings from the open-label Phase 1b portion of the trial indicated a reduction in stool frequency of 18% (13.09 daily to 10.69 average daily BMs), and a 28% reduction in average nighttime awakenings (2.39 nightly average to 1.73 BMs) after four weeks of treatment. No serious adverse events were reported. The Phase 2 portion of the study will begin enrolling in January 2025 at eight clinical sites in the US.

"We are pleased to see these favorable early results for the EXE-346 product in terms of both safety and efficacy," commented Dr. Hans Herfarth, director of the University of North Carolina Multidisciplinary IBD Center. "With this data we can confidently move into the Phase 2 placebo-controlled portion of the study, which we hope will demonstrate effectiveness in these key outcomes which significantly impact the lifestyles of IPAA patients."

More information about the PROF study (NCT05938465) is at available at clinicaltrials.gov. 

About ExeGi Pharma

ExeGi Pharma LLC is a biotechnology company focused on developing and commercializing live biotherapeutic and probiotic medicines. ExeGi's team leverages scientific expertise in the field of microbiome science to deliver novel, clinically supported live biotherapeutic and probiotic products for a variety of unmet health and medical needs. ExeGi Pharma is dedicated to creating environmentally friendly products that balance business needs with green initiatives.

About EXE-346

EXE‑346 is a live biotherapeutic product (LBP) that is a blend of eight lyophilized, probiotic bacteria formulated in extremely high doses and manufactured to biologic-grade cGMP standards. The product is currently under development to manage excessive stool frequency in patients who have undergone an ileal pouch-anal anastomosis (IPAA).

ExeGi Pharma is headquartered in Rockville, MD. www.exegipharma.com.

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SOURCE ExeGi Pharma