Seres Therapeutics Inc. (NASDAQ: MCRB) shares more than tripled early on Monday after the firm announced positive late-stage results for its C. difficile infection (CDI) study. Overall, the company exceeded expectations.
Ultimately, the study demonstrated that SER-109 administration resulted in a highly statistically significant absolute decrease of 30.2% in the proportion of patients who experienced a recurrence in CDI within eight weeks compared with the placebo.
Also, 11.1% of patients administered SER-109 experienced a CDI recurrence, versus 41.3% of placebo patients. The study results were equally compelling when characterized by the alternative metric of sustained clinical response, where 88.9% of patients in the SER-109 arm achieved this objective.
Again, the study’s efficacy results exceeded the statistical threshold previously provided by the FDA. Also, the SER-109 safety results were favorable, with an adverse event profile comparable to placebo.
Management noted that, based on its prior discussions with the FDA, it believes this trial should provide the efficacy basis for submitting an application for product approval. CEO Eric Shaff said that he looks forward to meeting with the FDA as soon as possible to discuss the regulatory path forward with the goal of bringing SER-109 to patients as a first-in-class microbiome therapeutic.
These results represent the first-ever positive pivotal clinical study results for a targeted microbiome drug candidate. The Phase 3 results provided a strong validation for the underlying microbiome therapeutics platform, which has been the scientific basis for the firm.
Excluding Monday’s move, the shares were up about 34% year to date. In the past 52 weeks, they were up closer to 76%.
Seres Therapeutics stock traded up about 306% to $18.85 early Monday, in a 52-week range of $2.52 to $6.75. The consensus price target is $8.08.