Seres Therapeutics reported results from an interim phase 2 trial for its colon infection treatment weren't found to be statistically significant.
Here are seven points:
1. The treatment, SER-109, is intended for multiply recurrent Clostridium difficile infection.
2. The study enrolled 89 subjects with multiply recurrent CDI, which is defined as three or more recent recurrences.
3. The randomized, double-blind, placebo-controlled 24-week study aimed to evaluate the safety and efficacy of SER-109.
4. Based on the eight-week data, the researchers did not see any difference in the adverse event frequency or type in the patients receiving SER-109 as compared to those receiving placebo.
5. The most commonly reported adverse events in both the SER-109 and placebo groups were in the gastrointestinal category.
6. Roger Pomerantz, MD, president, chairman and CEO of Seres said these were unexpected "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."
7. Seres Therapeutics stock plummeted 78 percent in pre-market trade on July 29, following the news of the trial results.