Yearly Archives2024

ExeGi Pharma Positive Topline Results in EXE-346 PROF Phase 1b Study standard

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 ...

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De Simone Formulation Named in AGA Clinical Practice Guidelines on Management of Pouchitis and Inflammatory Pouch Disorders standard

Pouchitis is an inflammatory condition that may occur in patients who have undergone an ileal pouch anal anastomosis (IPAA). The symptoms associated with pouchitis can be debilitating for patients and treatment options, especially for those who have symptoms resistant to antibiotics, are limited.  The De Simone Formulation found only in Visbiome high potency probiotics, was recently named in the American Gastrointestinal Association (AGA) Clinical Practice Guidelines on Management of Inflammatory Pouch Disorders. These guidelines are developed from a multidisciplinary panel of experts utilizing the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system to analyze existing evidence and develop recommendations for the prevention and treatment of pouchitis. Within their newly updated recommendations for prevention of pouchitis, the AGA guidelines “suggests ...

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