The expansion follows the successful completion of the study’s two initial cohorts and is intended to explore reduced dosing regimens of RBX7455 in two new treatment arms.
Additional cohorts to examine potential of reduced dosing regimens of RBX7455 for the prevention of recurrent Clostridium difficile infection |
| [29-November-2017] |
| ROSEVILLE, Minn., Nov. 29, 2017 /PRNewswire/ -- Rebiotix, a clinical-stage microbiome company focused on harnessing the power of the human microbiome to treat challenging diseases, announced today an expansion of the investigator sponsored Phase 1 study of RBX7455 for the prevention of recurrent Clostridium difficile (C. diff.) infection. The expansion follows the successful completion of the study’s two initial cohorts and is intended to explore reduced dosing regimens of RBX7455 in two new treatment arms. 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. “Expansion of the Phase 1 study is a key advancement in the development of RBX7455 as it provides an opportunity to explore the potential efficacy of reduced dosing regimens of our oral capsule product in the prevention of recurrent C. diff. infection,” stated Lee Jones, president and CEO of Rebiotix. “RBX7455 is a ground-breaking product in that its oral capsule design is the first in the microbiome industry not requiring storage in frozen conditions. As such, patients are able to administer RBX7455 at home as they would a typical oral capsule medication, which potentially makes RBX7455 ideally suited for diseases where chronic or repeat dosing is required.” The Phase 1 study of RBX7455 is an investigator sponsored, prospective, single center, proof of concept dosing study of RBX7455 for the prevention of recurrent C. diff. infection. The first two arms enrolled 10 patients per arm (20 total). The expansion of the Phase 1 study adds two additional arms, which will enroll approximately 10 patients per arm (20 total) with reduced dosing regimens from the first two arms. Rebiotix expects data from the first two cohorts of the Phase 1 study of RBX7455 to be released publicly by mid-2018. In addition to the expanded Phase 1 study of RBX7455, Rebiotix’s clinical development pipeline is highlighted by the company’s ongoing Phase 3 clinical trial of RBX2660 for the prevention of recurrent C. diff. infection. RBX2660 is the first and only microbiome drug to be tested in three separate Phase 2 trials, with more than 300 subjects having been treated with the microbial therapy. Recently, Rebiotix announced the presentation of research from the RBX2660 Phase 2 program demonstrating measurable evidence of the drug’s rehabilitative effect on the human microbiome and the potential advantages of its broad consortia design. Ms. Jones continued, “We look forward to the continued progress of the RBX7455 Phase 1 study as well as our Phase 3 study of RBX2660, our lead microbiome drug candidate. Importantly, since both drugs were developed with our MRT platform, we can leverage knowledge from the extensive RBX2660 clinical program, as well as research into the drug’s rehabilitative impact on the gut microbiome, to inform and expedite the development of RBX7455.” About Clostridium difficile Infection About Rebiotix Inc. Rebiotix Media Contact: SOURCE Rebiotix Inc. |
