Seres Therapeutics Presents Latest Data from ECOSPOR III Phase 3 SER-109 Study in Recurrent C. Difficult Infection at IDWeek2021
– In ECOSPOR III, experimental microbiome therapy SER-109 was associated with greater reduction of antimicrobial resistance genes in patients with relapsing CDI compared to placebo –
CAMBRIDGE, Mass., October 02, 2021– (BUSINESS WIRE) – Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced the latest data from its Phase 3 ECOSPOR III study evaluating SER-109 , an experimental treatment of the oral microbiome for relapses It’s hard infection (rCDI). SER-109 was associated with a significantly greater reduction in antimicrobial resistance (ARG) genes compared to placebo, the reduction being observed both rapidly (at week 1) and sustained through week 8 of the ‘study. These data, presented by Timothy Straub on October 2 at the IDWeek 2021 virtual conference, support the potential role of microbiome therapeutics in the rapid decolonization of antibiotic-resistant bacteria.
“As the gastrointestinal microbiome is the first line of defense against colonization by antimicrobial resistant bacteria, this exploratory analysis is essential to understanding the potential of SER-109 and our microbiome pipeline more broadly,” said Lisa von Moltke, MD, Chief Medical Officer at Seres. “As one of the most pressing bacterial threats in the United States and a leading cause of hospital acquired infection, providing patients with safer and more effective treatment options is at the forefront of our mission as we are working to potentially bring the very first FDA-approved therapeutic microbiome for people with It’s hard. “
The Phase 3 SER-109 ECOSPOR III study (ClinicalTrials.gov: NCT03183128) was a multicenter, randomized, placebo-controlled study. Previously reported baseline data indicated that the study met its primary endpoint at eight weeks and demonstrated a sustained clinical response rate of approximately 88% at eight weeks after treatment. SER-109 resulted in a 27% absolute reduction in CDI recurrence compared to placebo eight weeks after treatment, representing a relative risk reduction of 68%. In May 2021, Seres presented clinical data over 24 weeks of the study that demonstrated significantly reduced recurrence rates compared to placebo over 24 weeks (21.3% vs. 47.3%, respectively). SER-109 was well tolerated, no serious treatment-related adverse events were observed in the active arm and an adverse event profile comparable to that of placebo. Seres plans to apply for a Biologics License (BLA) with the United States Food and Drug Administration in mid-2022.
Data is available to registered participants on the virtual platform for the duration of the IDWeek conference at www.IDWeek.org.
About the SER-109
SER-109 is a therapeutic candidate for the oral microbiome composed of a consortium of highly purified Firmicutes spores, which normally live in the healthy microbiome. SER-109 is designed to prevent further recurrence of CDI in patients with a history of multiple infections by modulating the disrupted microbiome to a state that resists It’s hard colonization and growth. The SER-109 manufacturing purification process is designed to remove unwanted microbes, reducing the risk of pathogen transmission beyond just screening donors. The US FDA has granted breakthrough therapy designation SER-109 and orphan drug designation for the treatment of rCDI.
About Seres Therapeutics
Seres Therapeutics, Inc. (Nasdaq: MCRB) is a leading microbiome therapy company developing a new class of multifunctional bacterial consortia designed to functionally interact with host cells and tissues to treat disease. Seres’ SER-109 program achieved the first-ever positive pivotal clinical results for a microbiome-targeted drug candidate and achieved breakthrough therapy and orphan drug designations from the FDA. SER-109 program advances in treatment of recurrence It’s hard infection and has the potential to become a top-notch FDA-approved microbiome therapy. Seres is evaluating SER-301 in a phase 1b study in patients with ulcerative colitis and SER-155 in a phase 1b study to treat gastrointestinal infections, bacteremia and graft versus host disease. 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 in this press release that do not relate to historical facts should be considered as forward-looking statements, including potential role of microbiome therapeutics in the decolonization of antibiotic resistant bacteria, the potential approval of SER-109 and its first-class therapeutic status, the timing of a BLA deposition, the ultimate safety profile of SER- 109, the potential of microbiome therapeutics to treat and prevent disease, the timing and results of our clinical studies, the ultimate safety and efficacy data from our products, and other statements that are not fact historical.
These forward-looking statements are based on the current expectations of management. These statements are not promises or 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 future results, performance or achievements. expressed or implied by forward-looking statements. statements, including, but not limited to the following: we have incurred significant losses, are not currently profitable and may never become so; our need for additional financing; our limited operating history; the impact of the COVID-19 pandemic; our untested approach to therapeutic intervention; the long, 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 market our product candidates, if approved; and our ability to retain key personnel and manage our growth. These and other important factors discussed under “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC, August 3, 2021, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by forward-looking statements made in this press release. These forward-looking statements represent management’s estimates as of the date of this press release. While we may choose to update these forward-looking statements at some time in the future, we disclaim any obligation to do so, even if subsequent events change our view. These forward-looking statements should not be taken as representing our views as of any date subsequent to the date of this press release.
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Carlo Tanzi, Ph.D.