ROCKVILLE, Md., Jan. 26,
2023 /PRNewswire/ -- ExeGi Pharma LLC, a leader in
the development of live biotherapeutic drugs and probiotics,
announced today that the FDA has cleared its Investigational New
Drug (IND) application for its biologic drug candidate, EXE-346.
This clearance allows the company to initiate a clinical trial for
patients with an ileal pouch-anal anastomosis (IPAA or "J-Pouch")
who experience excessive stool frequency.
"Excessive stool frequency is a significant challenge for many
patients with a J-Pouch, and we are pleased to have the opportunity
to investigate the potential benefits of EXE-346," commented Dr.
Hans Herfarth, MD, Ph.D., of the
University of North Carolina
Inflammatory Bowel Disease Center. And "We believe that the live
biotherapeutic approach has the potential to revolutionize the way
we manage this condition."
An ileal pouch-anal anastomosis is a surgical procedure
typically performed because of unresolved inflammatory bowel
disease (IBD). The surgery creates an intestinal J-Pouch with a
portion of the lower intestine, allowing patients to avoid an
ostomy bag and pass stools normally. However, many patients with a
J-Pouch experience excessive daily stool frequency of six or more
times per day. Nighttime stool frequency is also a common
complication. The clinical study will seek to evaluate the safety
of EXE-346 and its initial efficacy in the potential reduction of
stool frequency.
EXE-346 is a unique live biotherapeutic biologic drug that
contains strains of live probiotic bacteria in extremely high
potency. There are currently no approved treatments for managing
excessive stool frequency in patients with a J-Pouch. ExeGi
anticipates initiating the study at multiple centers throughout the
U.S. in the summer of 2023.
About ExeGi Pharma:
ExeGi Pharma LLC is a biotechnology company focused on
developing and commercializing live biotherapeutic and probiotic
medicines. Our purpose is to formulate the most effective
probiotics and live biotherapeutics to provide relief from serious
conditions so people, and their pets, may live healthier lives.
ExeGi is headquartered in Rockville,
MD. www.ExeGiPharma.com
About EXE-346:
EXE–346 is a live biotherapeutic product (LBP) a blend of
probiotic bacteria formulated in extremely high potency 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).
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SOURCE ExeGi Pharma