Seres Therapeutics Announces Completion of Rolling BLA Submission to FDA for Investigational Microbiome Therapeutic SER-109 for Recurrent C. Difficile Infection
– Investigational therapeutic SER-109 has the potential to become the first-ever FDA-approved oral microbiome therapeutic –
– Anticipated product launch in the first half of 2023 –
“Completing this BLA submission marks a key milestone for Seres and, more importantly, a potential turning point for the treatment of nearly 170,000 cases of recurrent C. difficile infection each year in
SER-109 has FDA Breakthrough Therapy designation, which provides the potential for priority review of the BLA. If granted, Seres anticipates the potential approval and launch of SER-109 in the first half of 2023, with SER-109 potentially becoming the first ever FDA-approved oral microbiome therapeutic.
“After well over a decade of research, Seres has established strong leadership in the development of microbiome therapeutics with a promising pipeline,” said
The submission is supported by the results of two Phase 3 studies: ECOSPOR III (NCT03183128) and ECOSPOR IV (NCT03183141). The ECOSPOR III study was a multicenter, randomized, placebo-controlled study, results of which were published in the
Seres entered into an agreement with Nestlé Health Science in
Building upon the proven mechanisms of SER-109 within Infection Protection, Seres is currently evaluating SER-155 in a Phase 1b study in individuals undergoing allogeneic hematopoietic stem cell transplantation and at elevated risk of life-threatening infections. Seres is also advancing additional preclinical stage programs targeting Infection Protection and combating the slow pandemic of antimicrobial resistant infections more broadly.
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 prevent further recurrences 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 therapeutic; the timing of a BLA acceptance and potential product launch; the potential market for SER-109; the anticipated indication of SER-109; our manufacturing capabilities; 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