Tag Archives: What other options are there to treat C.diffiicle?

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.

View source version on businesswire.com:https://www.businesswire.com/news/home/20190208005039/en/

C. diff. Spores and More, Join Us and Celebrate

www.cdiffradio.com

C. diff. Spores and More

Sponsored by Clorox Healthcare

Join us and Celebrate

with our 81,453 listeners – so far –  in Season III.

We thank our listeners joining us every

Tuesday at 10:00 a.m. PT / 1:00 p.m. ET

across the U.S. A. and to our listeners in

  • Australia
  • Brazil
  • Canada
  • China
  • France
  • Germany
  • India
  • Ireland
  • Israel
  • Japan
  • Malaysia
  • Peru
  • Russia
  • Spain
  • Switzerland
  • Taiwan
  • Trinidad
  • Ukraine
  • UK    and Across the Globe

We also extend our sincere gratitude to the guests who take time out of their busy

schedules to join us on each live broadcast.  Though their words of wisdom and

by sharing the most up-to-date information with us raises awareness in so

many important areas of healthcare.

 

Season III concludes on October 31, 2017

and we will be gearing up for

the 5th Annual International C. diff. Awareness Conference & Health EXPO taking

place on November 9th and 10th at the University of Nevada – Las Vegas.

For conference information please click on the link below.

https://cdifffoundation.org/2017cdiffconference/about-nov-2017-annual-conference/

 

Join us in Season IV when we return on January 9th, 2018

as we continue bringing you updates that are focused on, but not limited to,

C. difficile infection prevention, treatments, clinical trials, environmental safety

and much more.

Thank you again for listening and we wish you and your families improved health,

continued healing, and the best day — which you all deserve!