- 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