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Rockville, Md. – ExeGi Pharma, a biotechnology company specializing in live biotherapeutics, today announced the 25th anniversary of the De Simone Formulation, a high potency probiotic blend that has transformed the landscape of gastrointestinal care. The formulation first gained clinical prominence in August 2000, when Professor Paolo Gionchetti and colleagues published a landmark study demonstrating that this probiotic benefits in a serious chronic inflammatory gastrointestinal disorder called pouchitis.1 That 2000 study – a breakthrough for the probiotic industry – showed significant benefits vs placebo and underscored the formulation’s potential to alter the course of serious gastrointestinal conditions. It also marked one of the first times a probiotic therapy proved superior to placebo in a rigorous clinical trial which was published in ...

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 ...

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 ...

Rockville, MD – ExeGi Pharma LLC, a leader in digestive health solutions, is proud to announce that its flagship product, Visbiome GI Care Probiotic Capsules, has achieved the prestigious Clean Label Project® Certification and Clean Label Project Pesticide Free Certification. The Clean Label Project is a national nonprofit consumer advocacy and standards development organization focused on health and transparency in consumer product labeling. Through its rigorous testing and certification program, the Clean Label Project ensures that products meet the highest standards for ingredient purity and quality. “Our customers trust Visbiome to support their digestive health with the highest-quality probiotics subjected to extensive clinical testing,” said Marc Tewey, CEO of ExeGi Pharma. “Securing the Clean Label Project Certification is a testament to ...

April 5, 2023 – ExeGi Pharma, LLC, owner of the Visbiome probiotic, has secured a significant legal victory against Brookfield Pharmaceuticals, LLC. ExeGi alleged that Brookfield engaged in false advertising and unfair competition by promoting its High Potency Probiotic (“HPP”) as a generic equivalent of Visbiome. The United States District Court for the Eastern District of Wisconsin ruled in favor of ExeGi, entering summary judgment and finding Brookfield liable for false advertising under the Lanham Act. The court also issued a permanent injunction against Brookfield to prevent the company from making any such false claims in the future. The court found that the Brookfield HPP product has a different composition than that of Visbiome, and Brookfield attempted to pass off HPP as a Visbiome generic equivalent. In a 44-page opinion, Judge J.P. Stadtmueller ...

ROCKVILLE, Md., July 13, 2020 ExeGi Pharma LLC, a U.S.-based company focused on developing and commercializing products targeting the human microbiome, including live biotherapeutic products (LBPs), announced today the results of a 70-patient clinical trial evaluating a new biologic drug candidate in hospitalized COVID-19 patients. The study was conducted in a hospital setting in Rome and published in the peer-reviewed journal Frontiers in Medicine. It compared outcomes of patients who received standard drug treatments alone or standard treatments combined with an oral bacteriotherapy. COVID-19 crisis exploded in Italy and clinicians struggled to navigate patient care. Investigators at Policlinico Umberto I, “Sapienza” University of Rome hypothesis that a bacterial formulation, with a specific biochemical and immunological profile, could trigger the production of ...

Federal district court finds in favor of ExeGi and probiotic inventor, prohibits VSL#3 sellers from citing studies on original formulation ROCKVILLE, Md., June 25, 2019 /PRNewswire/ — ExeGi Pharma LLC is pleased to announce that on Friday, June 21, the United States District Court for the District of Maryland ruled in favor of a probiotic inventor and his business partner, ExeGi Pharma, LLC, in post-trial motions concerning the probiotic product VSL#3®. The ruling concludes over four years of litigation in which the inventor of the well-studied De Simone formulation probiotic (sold until July 2016under the name VSL#3) sought to defend his ownership rights and prevent his former business partners from claiming that a reverse-engineered imitation product was, in fact, his own formulation. On November 2018, a federal jury unanimously found ...

Claudio De Simone, inventor of high-potency probiotic, sued pharmaceutical companies for making false advertising claims, ownership rights to the product formula and unpaid royalties November 26, 2018 09:30 AM Eastern Standard Time GREENBELT, Md. – A federal jury on Tuesday, Nov. 20, unanimously ruled in favor of a probiotic inventor who sued his former business partners after an international dispute concerning false advertising, ownership of a proprietary formulation and unpaid royalties. The inventor accused his former partners of attempting to make a copy of his invention and selling it to unsuspecting patients under the same brand name, even though the copy product had never been clinically tested. The three-week trial in the U.S. District Court for the District of Maryland ...

Clinical studies show a probiotic used to manage human GI disorders can help support bowel and gut health in dogs. ExeGi Pharma Launches a high potency veterinary probiotic for companion animals. ROCKVILLE, MD ExeGi Pharma LLC, a company focused on developing and commercializing live biotherapeutics and probiotic treatments, announced today the new Visbiome ® Vet. A new high potency veterinary probiotic for use in companion animals to help support normal inflammatory responses in the gastrointestinal tract (GI tract) and to help normalize gut health. The formulation in Visbiome Vet contains an eight-strain proprietary probiotic blend. This formulation has recently been studied in several canine GI disorders with two clinical trials published in the last 12 months. Moreover, Visbiome Vet is ...