ROCKVILLE, MD – ExeGi Pharma, a pioneering biopharmaceutical company dedicated to the development and commercialization of innovative live biotherapeutics, has announced the first patient enrollment in its landmark PROF Trial. The trial will study the potential of EXE-346, a novel live biotherapeutic, as treatment for excessive stool frequency in patients with an ileal pouch-anal anastomosis. Live biotherapeutics are similar to probiotics in that they contain live beneficial bacteria, however live biotherapeutics as therapeutic drug products require FDA approval.

Ileal pouch-anal anastomosis (IPAA) is a surgical procedure often employed for patients with ulcerative colitis which results in a significantly altered gastrointestinal tract. A subset of these patients experience chronic excessive stool frequency, which severely impacts their quality of life. EXE-346 aims to offer hope and a potential solution to this issue.

Dr. Hans Herfarth, the principal investigator for the PROF Trial and Director of the University of North Carolina Multidisciplinary IBD Center commented, "We are optimistic about the potential of EXE-346. This trial represents a significant step forward in our commitment to improving outcomes and advancing the standard of care for patients suffering from complications associated with ileal pouch-anal anastomosis."

The PROF Trial is anticipated to provide valuable insights into the therapeutic application of EXE-346 in IPAA patients with debilitating stool frequency challenges.

"We are excited to embark on this pivotal trial, and the enrollment of our first patient is a monumental milestone," said Marc Tewey, CEO of ExeGi Pharma. "We remain deeply committed to developing groundbreaking solutions and hope that EXE-346 will pave the way for a new era in the management of ileal pouch disorders."

The PROF Trial will continue patient recruitment across multiple sites, aiming for robust and comprehensive results that will guide future applications of EXE-346.

For more information on the PROF Trial, please refer to the clinicaltrials.gov posting (NCT05938465) or visit www.profclinicalstudy.com.

About ExeGi Pharma

ExeGi Pharma LLC is a biotechnology company focused on the development and commercialization of 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 is headquartered in Rockville, Md.