Posted On: 07/29/2016 9:25:35 AM
Post# of 72443
They also have an ulcerative colitis drug which may fail too, if the entire platform is based on faulty animal studies, right? I have to say, the dramatically unexpected results make me wonder if some of their clinical trial facilities didn't do the study properly -- same problem CTIX had with one of its test sites in which the chief investigator didn't comply with protocol. Fortunately for CTIX it was only one site out of several, and the problem was apparent.
http://www.marketwatch.com/story/seres-therap...2016-07-29
http://www.marketwatch.com/story/seres-therap...2016-07-29
Quote:
Roger Pomerantz, MD, President, Chief Executive Officer and Chairman of Seres commented: “These are unexpected clinical results in view of the positive data in our prior investigator-sponsored Phase 1b trial, as well as in a wide range of supporting clinical and preclinical data. Specifically, the recurrence rates observed in the overall SER-109 treatment group, in the age stratified subgroups, and in the placebo groups are inconsistent with our expectations. Our priority is to complete a full review of the clinical results and microbiome data of the Phase 2 study and to compare it to data from the prior investigator sponsored Phase 1b. Based on this information and pending discussions with the FDA, we plan to make any necessary changes to our development plans for SER-109.”
Dr. Pomerantz continued: “C. difficile infection treatment options, including unregulated fecal microbial transplants, remain poor. The confounding placebo data obtained in this study further highlight the significant need for new, effective, FDA regulated therapeutic options for these patients. We will take our learnings from this study and continue in our pioneering efforts to develop meaningful new microbiome therapeutics for C. difficile infection and other serious diseases.”
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