EXE-346

EXE-346 is a high-potency, live biotherapeutic product (LBP) under development by ExeGi Pharma. It consists of a fixed blend of eight strains of live, lyophilized probiotic bacteria. [4, 7] The drug is being investigated for patients who have undergone an ileal pouch-anal anastomosis (IPAA or J-pouch) and experience complications such as excessive stool frequency. [5, 7] It has also received Orphan Drug Designation from the U.S. FDA for the prevention of pouchitis relapse. [12] The proposed mechanism involves restoring a healthy balance in the gut microbiota to reduce inflammation and symptoms. [2, 12] A Phase 1b/2 clinical trial (the PROF study) began enrolling patients in December 2023 to assess the safety and efficacy of EXE-346 in reducing bowel movement frequency. [4]