Tag Archives: Recurrent C.difficile clinical trials

U.S. Food and Drug Administration (FDA) Grants Breakthrough Therapy Designation to Finch Therapeutics Investigational Drug CP101 for Treatment of Recurrent Clostridium difficile Infection (rCDI)

Finch Therapeutics Group, Inc., a clinical-stage microbiome therapeutics company, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to investigational drug CP101 for the treatment of patients with recurrent Clostridium difficile (C. difficile) infection. Breakthrough Therapy Designation is intended to expedite the development and review of investigational therapeutics for serious or life-threatening conditions where preliminary clinical evidence indicates that the product may demonstrate a substantial improvement over existing therapies on one or more clinically significant endpoints.

Finch’s lead therapeutic candidate CP101 is designed to prevent recurrent C. difficile, a bacterial infection affecting over 500,000 patients each year and leading to an estimated 29,000 annual deaths. Recurrent C. difficile has been named an urgent public health threat by the Centers for Disease Control (CDC) and, with a high percentage of patients failing standard-of-care antibiotic treatment, presents a clear and urgent unmet medical need.

“We are thrilled that CP101 has been designated as a Breakthrough Therapy for recurrent C. difficile,” said Mark Smith, CEO of Finch. “CP101 is designed to break the cycles of infection by restoring the balance of the gut microbiome, an approach supported by numerous clinical studies and Finch’s extensive experience providing microbial treatments to patients suffering from C. difficile. This designation will accelerate our efforts to provide an effective therapy for patients living with this devastating infection, and we look forward to working closely with the FDA to advance that mission.”

Finch is actively enrolling patients with recurrent C. difficile in PRISM3, a randomized, placebo-controlled Phase II clinical study to assess the safety and efficacy of CP101. The study drug is an oral capsule that is administered in a single dose. For more information about this trial, please visit www.prism3trial.com.

CP101 is not approved in any country.The FDA’s Breakthrough Therapy Designation does not constitute or guarantee a future approval and does not alter the standards for approval.

About Finch Therapeutics Group, Inc.Finch Therapeutics Group, Inc. (Finch) is developing novel microbial therapies to serve patients with serious unmet medical needs. Built on 30 years of translational research at OpenBiome, MIT, University of Minnesota and the Center for Digestive Diseases, Finch uses  Human-First Discovery  to develop therapies from microbes that have demonstrated clinically significant impacts on patient outcomes. Finch is unique in having both a donor-derived  Full-Spectrum Microbiota  ( FSM ) product platform and a  Rationally Selected Microbiota  ( RSM ) product platform based on microbes grown in pure culture. Finch’s lead program, CP101, is an investigational  FSM  product for prevention of recurrent  C. difficile  infections. Finch’s  RSM  platform employs machine-learning algorithms to mine Finch’s unique clinical datasets, reverse engineering successful clinical experience to identify the key microbes driving patient outcomes. Finch has a strategic partnership with Takeda to develop FIN-524, an investigational  RSM  product for inflammatory bowel disease. Finch is using a rich foundation of clinical data to advance its pipeline, leveraging proof-of-principle results to evaluate target indications and inform the design of this new therapeutic class.

Full-Spectrum Microbiota, FSM, Rationally-Selected Microbiota, RSM, and Human-First Discovery are trademarks of Finch Therapeutics Group, Inc.

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Rebiotix Announces Expansion of Phase 1 Study For Prevention of Recurrent C.diff. Infection Oral Capsule Microbiota Product RBX7455

Rebiotix Announces Expansion of Phase 1 Trial of the Company’s Oral
Capsule Microbiota Product, RBX7455, Following Successful Completion of
Initial Study Arms

Additional cohorts to examine potential of reduced dosing regimens of RBX7455 for the prevention of recurrent Clostridium difficile infection

Rebiotix Inc., a clinical-stage microbiome company
focused on harnessing the power of the human microbiome to treat challenging diseases, announced on November 30, 2017
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 2
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 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 challenging 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 nonfrozen,
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 TherapyTM (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