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Seres Therapeutics Presents Data Supporting its Microbiome Pipeline at IDWeek 2021, Including Data from SER-109 Phase 3 ECOSPOR III Study in Recurrent C. Difficile Infection


Benzinga | Sep 29, 2021 02:01PM EDT

Seres Therapeutics Presents Data Supporting its Microbiome Pipeline at IDWeek 2021, Including Data from SER-109 Phase 3 ECOSPOR III Study in Recurrent C. Difficile Infection

-- Data presented highlights significant impact of SER-109 on health-related quality of life (HRQoL) and reduction of recurrence regardless of risk factors --

-- Preclinical assessments support the ability of SER-155 to decolonize antibiotic-resistant pathogens, potentially reducing the risk of subsequent infection --

Seres Therapeutics, Inc. (NASDAQ:MCRB), a leading microbiome therapeutics company, today announced data from its Phase 3 ECOSPOR III study evaluating SER-109, an investigational oral microbiome therapy for recurrent C. difficile infection (rCDI), will be presented at the IDWeek 2021 Virtual Conference (Sept. 29-Oct. 3). The Company will be presenting seven posters and oral presentations related to SER-109 and C. difficile, including a late-breaker, as well as an oral presentation on SER-155, an investigational cultivated microbiome therapeutic entering clinical development designed to reduce the risk of gastrointestinal antibiotic-resistant bacterial infections, bacteremia and graft-versus-host-disease (GvHD) in immunocompromised patients.

Notably, exploratory analyses of SER-109 data revealed that SER-109 was associated with improved overall and mental health scores compared to baseline regardless of clinical outcome, as measured by CDiff32 (presenting author: Kevin Garey, PharmD, M.S.). Another poster highlights that despite more than half of the patient population in ECOSPOR III having at least one co-morbidity, SER-109 was observed to significantly reduce the incidence of recurrence compared to placebo in these patients. SER-109 was observed to reduce CDI recurrence among patients at risk for recurrence because of age, gender, proton pump inhibitor use, and/or co-morbidities such as diabetes, cardiac disease and malignancy, in comparison to placebo (presenting author: Stuart Cohen, M.D.).

"The data we're presenting at IDWeek 2021 further validates the strength of our investigational microbiome pipeline as we urgently work to address the unmet treatment needs for both recurrent C. difficile infection and immunocompromised patients," said Lisa von Moltke, M.D., Chief Medical Officer at Seres. "We believe microbiome therapeutics have the potential to target multiple disease pathways and offer new, potentially transformative treatment options for patients in need."

The oral presentation by Elizabeth Halvorsen, Ph.D. on SER-155, an investigational cultivated microbiome therapeutic, will highlight preclinical data showing that SER-155 can decolonize antibiotic-resistant pathogens (VRE: vancomycin-resistant Enterococcus faecium and CRE: carbapenem-resistant Klebsiella pneumoniae); potentially reducing the risk of subsequent infection.

In addition, Seres is presenting the following SER-109-related posters and a late-breaker presentation at IDWeek 2021:

* SER-109, an Investigational Microbiome Therapeutic, Reduces Abundance of Antimicrobial Resistance Genes in Patients with Recurrent Clostridioides difficile Infection (rCDI) after Standard-of-Care Antibiotics, Saturday, October 2, 1:15 PM -- 3:00 PM ET, Presenting Author: Timothy Straub (late-breaker)

* Manufacturing Processes of SER-109, a Purified Investigational Microbiome Therapeutic, Reduce Risk of Transmission of Emerging and Undetected Infections in Donor Stool, Presenting Author: Christopher McChalicher

* Diagnostic Testing Among Patients with Suspected Recurrent Clostridioides difficile Infection (rCDI) in ECOSPOR III a Phase 3 Clinical Trial: Implications for Clinical Practices vs Clinical Trials, Presenting Author: Matthew Sims

* Time to Recurrence of Clostridioides difficile Infection (rCDI) is Rapid Following Completion of Standard of Care Antibiotics: Results from ECOSPOR-III, a Phase 3 Double-Blind, Placebo-Controlled Randomized Trial of SER-109, an Investigational Microbiome Therapeutic, Presenting Author: Thomas Louie

* The Burden of Illness Associated with Recurrent Clostridioides difficile Infection: A Claims-based Analysis, Presenting Author: Rachel Black

In addition, Paul Feuerstadt, M.D. will be providing a sponsored talk on Friday, October 1 at 2:00-2:45 PM ET, entitled "Perspectives on the Pathogenesis of Recurrent Clostridioides difficile Infection: Insights into Microbiome Science."

The data is available to registered attendees on the virtual platform throughout the duration of the IDWeek Conference at www.IDWeek.org.






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