Surprise for Seres as shares sent tumbling by Phase II failure
pharmafile | August 1, 2016 | News story | Research and Development, Sales and Marketing | FDA, clostrodium difficile, seres therapeutics
Seres Therapeutics has presented interim results from an ongoing Phase II trial which has sent company stock spiralling downward, as their lead candidate for Clostrodium Difficle infection (CDI) prevention failed to meet its primary endpoint.
SER-109 did not manage to reduce the relative risk of CDI recurrence at up to eight weeks. As a result, the company’s share price plummeted almost 70%.
In the trial, which enrolled 89 patients across 36 centres in the US, CDI recurrence occurred in 44% of subjects who received SER-109 compared to 53% of patients who received placebo.
Roger Pomerantz, CEO at Seres, says: “These are unexpected clinical results in view of the positive data in our prior investigator-sponsored Phase Ib 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 groups, and in the placebo group are inconsistent with our expectations. Based on this information and pending discussions with the FDA, we plan to make any necessary changes to our development plans for SER-109.”
Seres had raised around $130 million in an initial public offering last year to develop their class of “healthy gut” drugs to treat infections such as C. diff. Last month, there was better news in the fight against CDA as MSD’s drug candidate, Zinplava (bezlotoxumab), was endorsed by an FDA advisory committee.
Sean Murray
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