It may seem incredible, but specialized microbes that reside in the colon are delicate. They face a hard road traveled to arrive and colonize so that they can be beneficial to our metabolism and immune system. Stomach acid kills most of them if not protected; Then there are digestive enzymes in the duodenum, and if they survive that, the immune system is active in the jejunum and ileum. Given orally in an unprotected capsule, most don’t make it, which is why successful FMT is given directly into the colon by a gastroenterologist. Inventors Kabadi and Schentag set out to change that constraint, designing a coating and a “capsule in a capsule” delivery system which both protects them in their travels and allows them to arrive in the colon alive and ready for beneficial actions. Issued patents are listed here with links to download
Kabadi M, Schentag JJ. Patent: Targeted Gastrointestinal Tract Delivery of Probiotic Organisms and/or Therapeutic Agents. US Provisional Application 61/781,810 filed on March 14, 2013 and US provisional application 61/897,378 Filed on October 30, 2013.Application number 14/771,830 Filed on March 14, 2014; also filed as PCT/US2014-027228 on March 14, 2014; Application 15/874,543 filed 2016(Published as WO 2014-152338 A1 on Sept 25, 2014; Published as US2016-0022592 A1 on Jan 28, 2016; ):Status: Issued as US 9,907,755 on March 6, 2018.
Abstract: The present invention relates to the development of a targeted delivery system for the oral delivery of probiotics or therapeutic agent for various indications, including and not limited to active and prophylaxis treatment of Clostridium difficile infection, antibiotic associated diarrhea, irritable bowel syndrome, Crohn’s disease, intestinal flora replacement, supplemental flora treatments for patients taking antibiotics, and for restoration of balance and signaling between the intestinal microbiome and the intestinal cells in patients under treatment of metabolic syndrome manifestations, specifically diabetes, insulin resistance, obesity, hyperlipidemia and hypertension. The present invention restores altered probiotic organism imbalances that are characteristic of said diseases among others as well as defines a platform technology development for site specific delivery of probiotic organisms in the GI tract of a mammal, most specifically the ileum and/or right colon of a human subject.
Global patent prosecution is Proceeding. This patent is now issued in Australia as 2014239883; Canada as 2,904,389; China as ZL201480014872.1; Japan as 6464142; A US divisional was granted as US 10,369,111 on August 6th, 2019. This patent family is Assigned to TheraBiome LLC. In 2013, the patent family was licensed to Assembly Biosciences by TheraBiome. The microbiome patent is under active development by Assembly BioSciences for one or more GI conditions or diseases. For details, click the link to the Assembly website, which is the only available source for information.