Tag Archives: Recurrent C. diff. treatment clinical study

Rebiotix Is Issued U.S. Patent For Its Patent Application Entitled “Microbiota Restoration Therapy (MRT) Compositions and Methods Of Manufacture”

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.”

https://cdifffoundation.org/clinical-trials-2/

 

About Rebiotix Inc.

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 difficile infection (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.

source:  Rebiotix

C. diff. Prevention of Recurrent C. diff. Infection (RCDI), Seres Therapeutics Announces Achievement of Target Enrollment of SER-109 Phase 2 Study

In The News: May 2, 2016

Seres Therapeutics Announces Achievement of Target Enrollment of SER-109 Phase 2 Study for the Prevention of Recurrent Clostridium difficile Infection

Phase 2 data expected in mid-2016

New SER-109 Expanded Access Program initiated at Phase 2 clinical sites

Seres Therapeutics, Inc.  a leading microbiome therapeutics platform company, announced that the target enrollment of 87 patients has been achieved for its ongoing SER-109 Phase 2 clinical study.

SER-109 is an oral, potential first-in-field microbiome therapeutic that has been granted Orphan Drug and Breakthrough Therapy designations by the U.S. Food and Drug Administration (FDA), and is being investigated for use in preventing recurrent Clostridium difficile infection (CDI).

“We are pleased to reach this important milestone in our ongoing development of SER-109, which has the potential to be the first therapy for C. difficile infection to treat the underlying cause of this disease, and the first microbiome drug for a human disease. This is the first placebo controlled trial for patients with multiply-recurrent CDI,” said Roger Pomerantz, M.D., Chairman, President, and CEO of Seres. “C. difficile infection is an extremely serious condition responsible for approximately 29,000 deaths each year in the United States alone. We are moving with urgency to develop SER-109 as quickly and safely as possible. We expect initial results of the Phase 2 study in the middle of this year, and we plan to initiate a Phase 3 study later in 2016.”

The SER-109 Phase 2 study (ClinicalTrials.gov identifier: NCT02437487) is a multicenter, randomized, placebo-controlled study being conducted at approximately 40 centers across the U.S. The current study builds on a completed, successful Phase 1b/2 trial, which demonstrated that 87 percent of patients (26 of 30) met the predefined endpoint of preventing recurrent CDI within eight weeks following administration of SER-109. In that study 97 percent of patients (29 of 30) achieved a clinical cure during the eight-week period after SER-109 dosing, as defined by the absence of CDI requiring antibiotic treatment. Results from the Phase 1b/2 have been published in The Journal of Infectious Disease.1

The Company has initiated a SER-109 Expanded Access Program at selected sites participating in the ongoing Phase 2 study. The Expanded Access Program will enable eligible patients with multiply-recurrent CDI to have continued access to SER-109. Furthermore, maintaining Phase 2 study sites open ahead of the anticipated start of the Phase 3 study expected to support and augment Phase 3 study execution and enrollment.

About Seres Therapeutics
Seres Therapeutics, Inc. is a leading microbiome therapeutics platform company developing a novel class of biological drugs that are designed to treat disease by restoring the function of a dysbiotic microbiome, where the natural state of bacterial diversity and function is imbalanced. Seres’ most advanced program, SER-109, has successfully completed a Phase 1b/2 study demonstrating a clinical benefit in patients with recurring Clostridium difficile infection (CDI) and is currently being evaluated in a Phase 2 study in recurring CDI. The FDA has granted SER-109 Orphan Drug, as well as Breakthrough Therapy, designations. Seres’ second clinical candidate, SER-287, is being evaluated in a Phase 1b study in patients with mild-to-moderate ulcerative colitis (UC). For more information, please visit www.serestherapeutics.com. Follow us on Twitter @SeresTx.

TO READ THE ARTICLE IN ITS ENTIRETY CLICK ON THE LINK BELOW:

http://ir.serestherapeutics.com/phoenix.zhtml?c=254006&p=irol-newsArticle&ID=2163658

Reference

1. Khanna S. et al., A novel microbiome therapeutic increases gut microbial diversity and prevents recurrent Clostridium difficile infection, Journal of Infectious Disease, 2016.

Note:  The C Diff Foundation does not endorse this product, or any product, and shares this article strictly for informational purposes.