Seres Therapeutics Inc. (NASDAQ:MCRB) is thrilled with the results from an oral microbiome therapeutic; SER-109, treatment for recurrent C. difficile infection (CDI). Results from the pivotal Phase 3 ECOSPOR III study were topline. Significant and absolute decrease of 30.2% in patients with a recurrence in CDI compared to those who received a placebo. Also, the results demonstrated sustained clinical response from 88.9% of patients.
There was oral administration of SER-109, or placebo, for three consecutive days to the 182 patients enrolled. They all had multiplied recurrent CDI and it was a requirement to have a positive C. difficile toxin diagnostic test. Either at the point of entry for the study or in the case of suspected recurrence.
Tolerability was observed, and there were no serious adverse events (SAEs) apart from abdominal pain, distention, and flatulence. However, they were generally mild
The Study’s Efficacy Results Surpassed the Statistical Edge
According to Eric D. Shaff, the CEO of Seres, this was a landmark study, thanks to the highly clinically and meaningful results. They were not only favorable, but they also had an adverse event profile equivalent to that of placebo. The results were beyond what was expected from a previous consultation with the FDA.
Going forward, Shaff says they are optimistic that the trial will offer a platform of efficacy for applying for product endorsement. ‘’…We look forward to meeting with the FDA as soon as possible to discuss the regulatory path forward to bring SER-109 to patients as a first-in-class microbiome therapeutic,” the CEO emphasized.
There is potential to transform the lives fundamentally
It is approximated that 170,000 patients in the U.S. are suffering from recurrent C. difficile infection. The disease devastates their quality of life and may result in death in the most severe cases. Hence, Seres says it is determined to adhere to new scientific learnings, leading to the advancement of its ongoing microbiome therapeutic programs.
These are positive efforts and recognizable efforts given the world’s current status quo, which has been brought to a halt by the COVID-19 pandemic.