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ExeGi Pharma Announces Clearance of Investigational New Drug (IND) Application for EXE-346 a Live Biotherapeutic Biologic Drug

2023-01-27

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临床申请

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.

FDA Clears ExeGi IND

"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-PoucEXE-346a portion of the lower intestine, allowing patients to avoid an ostomy bag and Inflammatory Bowel Diseasever, 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 bactinflammatory bowel disease (IBD)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.EXE-346

EXE-346xeGi Pharma:ExeGi

ExeGi ExeGi Pharmas 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

ExeGi Pharma LLC ExeGi

EXE–34EXE-346live 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).

SOURCE ExeGi Pharma

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