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ABI-M101 is an oral live biotherapeutic product developed by Assembly Biosciences as part of their microbiome platform. It consists of systematically selected bacterial strains designed to restore health to a dysbiotic microbiome. The product utilizes Assembly's proprietary GEMICEL™ oral delivery technology, which allows for targeted delivery of live biologics to the lower gastrointestinal tract. ABI-M101 was specifically developed for the treatment of recurrent Clostridioides difficile infections (rCDI), which is classified as a CDC urgent threat and represents the #1 US hospital-acquired infection, causing approximately 29,000 deaths annually and ~$5 billion in healthcare costs. The development program was designed to target patients who have relapsed after two or three standard antibiotic regimens.
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