Seres Therapeutics has unveiled the design of a phase 2 trial it thinks could secure FDA approval for its once-failed treatment for recurrent Clostridium difficile infection. The microbiome pioneer emerged from talks with FDA saying the regulator agrees the study may qualify as a pivotal trial if it achieves a “persuasive clinical effect.”
Cambridge, Massachusetts-based Seres went into talks with FDA earlier this year armed with its analyses of what went wrong in the earlier phase 2—which missed its primary endpoint leaving a lasting dent in the company’s share price—and its proposals for designing a better follow-up study. At the time, Seres asserted the trial failed because it misdiagnosed the C. difficile infection status of patients entering and during the study and gave subjects a suboptimal dose of SER-109.
Now, Seres says FDA agrees with its analyses and plans to avoid the same pitfalls in the next study.
Read more here: Fierce Biotech