After reporting non-statistically significant results in it a phase-II study, Cambridge, Mass.-based Seres Therapeutics is launching a revised phase-II study for its SER-109 Clostridium Difficile treatment.
Here's what you should know.
1. The new study will analyze approximately 320 patients with multiply recurrent C. Difficile infection.
2. Researchers will randomize participants one-to-one between SER-109 and a placebo.
3. To ensure accuracy, researchers will confirm C. Difficile with a cytotoxin assay.
4. Patients in the SER-109 branch will receive a dose over three days. This dose is approximately 10-fold higher than the dose in the prior study.
5. The study will run for 24 weeks. The primary endpoint will compare C. Difficile recurrence rates at up to eight weeks after dosing.
6. The FDA agreed the new study could qualify as a pivotal study if the drug achieves a persuasive effect and addresses FDA requirements.