Rebiotix Treats First Patient in Phase 1 Study of RBX7455, an Orally Delivered Broad-Spectrum Non-Frozen MicrobiotaROSEVILLE, Minn., Jan. 4, 2017
Rebiotix Inc., a clinical-stage biotechnology company focused on harnessing the power of the human microbiome to treat challenging diseases, announced today that the first patient has been treated in a Phase 1 study of RBX7455 for the prevention of recurrent Clostridium difficile (C. diff.) infection.
RBX7455 is a lyophilized non-frozen oral capsule formulation of Rebiotix’s Microbiota Restoration Therapy (MRT), 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.
RBX7455 lyophilized capsules remove the need for patients to keep the product frozen or refrigerated.
This prospective, single center, two-arm Phase 1 study is a proof of concept dosing study of RBX7455 for the prevention of recurrent C. diff. infection, an increasingly difficult-to-resolve intestinal infection that causes approximately 29,000 deaths in the U.S. each year.1 It is also the first clinical study of an oral microbiota therapy that allows the patient to take the medication at home.
RBX7455 requires no special handling or storage needs for patients. The study will enroll approximately 20 patients at a single U.S. site and is being conducted by the Mayo Clinic, a nonprofit worldwide leader in medical care, research and education.
“New therapies are urgently needed to prevent recurrent C. diff., a debilitating, costly and potentially life-threatening infection,” said Dr. Sahil Khanna, Assistant Professor of Medicine, Department of Gastroenterology and Hepatology, Mayo Clinic, who is leading the study. “RBX7455 not only provides standardized and stabilized human microbes orally, but may provide several advantages in terms of patient dosing and therapy accessibility since no freezing or refrigeration is needed when the patient takes the product home.”
The initiation of the Phase 1 study of RBX7455 enhances Rebiotix’s clinical pipeline of human microbiome-directed drug candidates. The Company’s lead drug candidate, RBX2660, recently completed a Phase 2b randomized, double-blind placebo-controlled trial examining the efficacy and safety of the microbiota restoration therapeutic as a prevention for recurrent C. diff. infection after a standard of care course of antibiotics (PUNCH CD2).
“Dosing the first patient in the Phase 1 study of RBX7455 is a significant milestone for Rebiotix as it solidifies our position as the most clinically advanced microbiome company in the industry, while showcasing the potential of our MRT platform to create new solutions for challenging diseases through standardized microbiota-based drug development,” stated Lee Jones, president and CEO of Rebiotix. ”
RBX7455 is a potentially ground-breaking product for Rebiotix and the entire microbiome industry in that the lyophilized oral capsules do not need to be kept frozen and thus can be stocked in a pharmacy with no special handling or storage needs. As such, RBX7455 offers the unique opportunity to introduce live microbial therapy as a potential treatment for numerous diseases where chronic or repeat dosing is required.”
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Rebiotix Inc., a clinical-stage biotechnology company focused on harnessing the power of the human microbiome to treat challenging diseases, announced on October 11, 2016 that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 9,433,651 to Rebiotix for its patent application entitled, “Microbiota Restoration Therapy (MRT), Compositions and Methods of Manufacture.” The patent covers Microbiota Restoration Therapy (MRT) compositions and methods for manufacturing, processing and delivering the compositions, and builds on Rebiotix’s patent issuances in Australia and Canada.
MRT is 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 readyto-use and easy-to-administer format. The patented technology is based on ground-breaking work that provides an avenue for the treatment of a variety of diseases including Clostridium difficile (C.diff), ulcerative colitis, hepatic encephalopathy and multi-drug resistant organisms.
“This patent covering our MRT platform is a significant addition to Rebiotix’s IP estate as we continue to advance our industry-leading pipeline of microbiome-directed drug therapies, including RBX2660, our Phase 3-ready drug candidate,” stated Lee Jones, Chief Executive Officer of Rebiotix. “Rebiotix has established one of the deepest IP portfolios in the microbiome industry covering an array of subjects, from formulation and storage to delivery and disease targets, that we believe are key to the eventual commercialization of microbiota-based therapeutics.”
Rebiotix Inc. is a clinical-stage biotechnology company focused on harnessing the power of the human microbiome to revolutionize the treatment of challenging diseases. Rebiotix is the most clinically advanced microbiome company in the industry, with its Phase 3-ready drug candidate, RBX2660, having successfully completed a Phase 2b randomized, double-blind, placebo controlled trial as a potential treatment for recurrent Clostridium difficileinfection (PUNCH CD2). RBX2660 has been granted Orphan Drug status, Fast Track status and Breakthrough Therapy Designation from the FDA for its potential to treat recurrent C. diff. infection.
Rebiotix’s development pipeline includes multiple formulations targeting several disease indications and is built around 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 spectrum 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.