Seres Therapeutics Announces FDA Acceptance of Biologics License Application for Investigational Microbiome Therapeutic SER-109 for Recurrent C. Difficile Infection for Priority Review
– If approved, SER-109 expected to be the first-ever FDA-approved oral microbiome therapeutic –
– PDUFA target action date is
– FDA advised that they are not currently planning to hold an Advisory Committee Meeting to discuss the SER-109 application –
– Company to hold commercial investor event on
“We are delighted by the FDA’s BLA acceptance for priority review, as we believe that SER-109 has the potential to fundamentally transform the management of rCDI,” said
SER-109 is an investigational microbiome therapeutic composed of purified Firmicutes spores for the treatment of rCDI, which shows promise to improve the current standard of care for this debilitating disease. With nearly 170,000 cases of rCDI each year in the
“We are working as quickly as possible to bring this first-ever oral microbiome therapeutic to patients most in need, if approved,” said
The application is supported by the results of a completed Phase 3 development program including ECOSPOR III (NCT03183128) and ECOSPOR IV (NCT03183141):
ECOSPOR III (SERES-012): A multicenter, randomized, placebo-controlled study that enrolled 182 adults with rCDI. Results published in the
New England Journal of Medicinein January showed that 88% of subjects in the SER-109 group were free from C. difficile recurrence at eight weeks post-treatment, compared to 60% in the placebo group. At 24 weeks post-treatment, 79% of the SER-109 group were still free from C. difficile recurrence, compared to 53% in the placebo group, reinforcing the durable relief. SER-109 was observed to be well tolerated with no drug-related serious adverse events.
- ECOSPOR IV (SERES-013): An open-label extension study of ECOSPOR III and open-label program for evaluating SER-109 in 263 adult subjects with rCDI at the commercial dose to fulfill FDA requirements for the SER-109 safety database. The study duration for both cohorts was approximately 27 weeks, including a three-week screening period, an eight-week primary efficacy period, and a 16-week follow-up period. Topline results indicated that the safety profile was well-tolerated and there was a 91% sustained clinical response at eight weeks in the overall population. At 24 weeks post-treatment, 86% of subjects treated with SER-109 experienced sustained clinical response.
Seres plans to host a SER-109 investor event, including participation by Aimmune, focused on the rCDI market opportunity and launch preparations on
SER-109 is an oral microbiome therapeutic candidate consisting of a consortium of highly purified Firmicutes spores, which normally live in a healthy microbiome. SER-109 is designed to reduce the recurrence of CDI by modulating the disrupted microbiome to a state that resists C. difficile colonization and growth. The SER-109 manufacturing purification process is designed to remove unwanted microbes, thereby reducing the risk of pathogen transmission beyond donor screening alone. The FDA has granted SER-109 Breakthrough Therapy designation and Orphan Drug designation for the prevention of rCDI.
For more information, please visit www.serestherapeutics.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including the potential approval of SER-109 and its status as a first-in-class oral therapeutic; the timing of potential product launch; the potential market for SER-109; the anticipated indication of SER-109; and other statements which are not historical fact.
These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding; our limited operating history; the impact of the COVID-19 pandemic; our unproven approach to therapeutic intervention; the lengthy, expensive and uncertain process of clinical drug development; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product candidates and develop and commercialize our product candidates, if approved; and our ability to retain key personnel and to manage our growth. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q filed with the