ROSEVILLE, Minn., Jan. 5, 2018 /PRNewswire/ — Rebiotix Inc., a clinical-stage microbiome company focused on harnessing the power of the human microbiome to treat debilitating diseases, announced today its successful first phase of collaboration with CoreBiome to measure the ability of RBX2660 and RBX7455 to rehabilitate the human microbiome impacted by recurrent Clostridium difficile (C. diff) infection. CoreBiome is a genomics platform company focused on accelerating microbiome innovation with expert genomics and big-data analytics. RBX2660, Rebiotix’s Phase 3 microbiome drug candidate, and RBX7455, its non-frozen oral capsule formulation, were both developed from the company’s Microbiota Restoration Therapy™ (MRT™) platform, a standardized, stabilized drug technology that is designed to rehabilitate the human microbiome by delivering a broad spectrum of live microbes into a patient’s intestinal tract via a ready-to-use and easy-to-administer format.
“Clinical studies of RBX2660 have demonstrated its potential to prevent recurrent C. diff infection, and early progress with RBX7455 has also been promising. Now, through our collaboration with CoreBiome and its BoosterShot™ technology, we can demonstrate how our drug platform rehabilitates a dysbiotic human microbiome,” stated Lee Jones, president and CEO of Rebiotix. “These analyses of RBX2660 and RBX7455 are important in not only understanding the mechanism of action of our microbiome drug technology in preventing recurrent C. diff, but they also help to pinpoint key elements of the microbiome that are indicative of dysbiosis associated with C. diff infection.”
Utilizing CoreBiome’s BoosterShot™ technology, researchers conducted DNA sequencing analyses of patient stool samples from a Phase 2 clinical trial of RBX2660 and from a Phase 1 Study for RBX7455. Results, which were presented at IDWeek™ 2017, indicated that treatment with RBX2660 shifted patients’ microbiome compositions, increasing the relative abundance of Bacteroidia, Clostridia and decreasing the relative abundance of Gammaproteobacteria; all of which are characteristic of a healthier microbiome. Importantly, a larger shift was seen in responders to RBX2600 compared to non-responders, and RBX2660 treatment appears to increase microbiome diversity. Data from the RBX7455 analysis will be presented at an upcoming medical conference. This research refines, advances and confirms prior analyses based on 16s sequencing of the microbiome.
“The ability to generate detailed quantitative evidence of how the human microbiome changes in response to drug technologies, such as Rebiotix’s RBX2660 and RBX7455, and how those changes correlate to treatment success is critically important to advancing microbiome therapeutics,” said Dan Knights, co-founder and CEO of CoreBiome. “We look forward to utilizing our BoosterShot™ technology in further research with Rebiotix as the company advances its multiple clinical programs.”
About Clostridium difficile Infection
Clostridium difficile (C. diff) infection is a serious and potentially fatal gastrointestinal disease, characterized by severe diarrhea, fever, and loss of appetite. It is a leading healthcare-associated infection (HAI), and in the U.S. alone, there are about 500,000 people infected and over 29,000 deaths annually from the disease. Currently, 20-30% of patients with C. diff go on to experience more than one episode of the disease, which is known as recurrent C. diff infection. Recurrent C. diff infection is especially challenging to treat as, to date, there are no approved microbial-based drugs to treat patients with two or more recurrences.
CoreBiome is a genomics platform company focused on accelerating discovery for customers in the pharmaceutical, agriculture, and research communities, to unleash the translational potential of the microbiome. The Company’s proprietary BenchMark™, BoosterShot™, BoostArray™, and Core Analysis™ platforms provide a rapid, affordable, and highly accurate measurement and interpretation of microbial diversity. Founded in 2016 based on intellectual property originating from the University of Minnesota, CoreBiome has rapidly moved from concept stage to full commercialization with the assistance of a seed funding round.
About Rebiotix Inc.
Rebiotix Inc. is a late-stage clinical microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of debilitating diseases. Rebiotix possesses a deep and diverse clinical pipeline, with its lead drug candidate, RBX2660, in Phase 3 clinical development for the prevention of recurrent Clostridium difficile (C. diff) infection. RBX2660 has been granted Fast Track status, Orphan Drug and Breakthrough Therapy designation from the FDA for its potential to prevent recurrent C. diff infection. Rebiotix’s clinical pipeline also features RBX7455, a lyophilized non-frozen, oral capsule formulation, which is currently the subject of an investigator-sponsored Phase 1 trial for the prevention of recurrent C. diff infection. In addition, Rebiotix is targeting several other disease states with drug products built on its pioneering Microbiota Restoration Therapy™ (MRT™) platform. MRT is a standardized, stabilized drug technology that is designed to rehabilitate the human microbiome by delivering a broad consortium of live microbes into a patient’s intestinal tract via a ready-to-use and easy-to-administer format. For more information on Rebiotix and its pipeline of human microbiome-directed therapies, visit www.rebiotix.com.