Shares in leading microbiome therapeutics platform, Seres Therapeutics (NASDAQ: MCRB) have surged higher premarket after the company announced positive results from its pivotal Phase 3 ECOSPOR III study…
“Our results represent the first-ever positive pivotal clinical study results for a targeted microbiome drug candidate. We believe these Phase 3 data provide strong validation for our underlying microbiome therapeutics platform, which has been the scientific basis for the Company, as well as persuasive clinical evidence supporting our other active pipeline programs,” said Eric D. Shaff, President and Chief Executive Officer of Seres.
The study was evaluating the investigational oral microbiome therapeutic SER-109, which is used for recurrent C. difficile infection (CDI). The company stated that it resulted in a “highly statistically significant absolute decrease of 30.2%,” in patients who experienced a recurrence in CDI during the eight weeks of administration versus the placebo, according to the company's press release.
After the news was released, shares in Seres surged higher premarket and are currently trading at $16.93, representing a 264.87% rise from Friday's close of $4.64 and reaching a level not seen since September 2017.
“Based on our prior discussions with the FDA, we believe this trial should provide the efficacy basis for submitting an application for product approval. We look 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,” said Shaff.