Seres Therapeutics Presents Data Supporting Its Microbiome Pipeline at IDWeek 2021, Including Data from the SER-109 Phase 3 ECOSPOR III Study in Recurrent C. Difficult Infection
CAMBRIDGE, Mass .– (COMMERCIAL THREAD) –Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced data from its Phase 3 ECOSPOR III study evaluating SER-109, an experimental oral microbiome treatment for recurrence It’s hard infection (rCDI), will be presented at the IDWeek 2021 virtual conference (September 29-October 3). The Company will present seven posters and oral presentations related to SER-109 and It’s hard, including a late presentation, as well as an oral presentation on SER-155, an investigational treatment of the cultured microbiome entering clinical development designed to reduce the risk of antibiotic-resistant gastrointestinal bacterial infections, bacteremia, and disease. graft versus host (GvHD) in immunocompromised patients.
Notably, exploratory analyzes of SER-109 data revealed that SER-109 was associated with improved overall and mental health scores from baseline, regardless of clinical outcome, as measured by CDiff32. (presenting author: Kevin Garey, PharmD, MS). Another poster points out that despite more than half of the patient population in ECOSPOR III having at least one comorbidity, SER-109 was observed to significantly reduce the incidence of recurrence compared to placebo in these patients. SER-109 has been observed to reduce recurrence of CDI in patients at risk of recurrence due to age, gender, use of proton pump inhibitors and / or co-morbidities such as diabetes, heart disease, and malignancies, compared to placebo (presenting author: Stuart Cohen, MD).
“The data we present at IDWeek 2021 further validates the strength of our experimental microbiome pipeline as we urgently work to address unmet treatment needs for both. VS. hard and immunocompromised patients, ”said Lisa von Moltke, MD, medical director of Seres. “We believe that microbiome therapies have the potential to target multiple disease pathways and offer potentially transformative new treatment options for patients in need. ”
Elizabeth Halvorsen, Ph.D.’s oral presentation on SER-155, an experimental therapeutics of the cultured microbiome, will highlight preclinical data showing that SER-155 can decolonize antibiotic-resistant pathogens (VRE: vancomycin-resistant Enterococcus faecium and CRE: resistant to carbapenems Klebsiella pneumoniae); potentially reduce the risk of further infection.
Additionally, Seres is showing the following posters related to SER-109 and a last minute presentation at IDWeek 2021:
SER-109, an experimental microbiome treatment, reduces the abundance of antimicrobial resistance genes in patients with recurrence Clostridioides difficile Infection (rCDI) after Standard-of-Care Antibiotics, Saturday, Oct. 2, 1:15 p.m. to 3:00 p.m. ET, lead author: Timothy Straub (end of break)
The manufacturing processes of SER-109, an investigational drug purified for the microbiome, reduce the risk of transmitting emerging and undetected infections in donor stool, Principal author: Christopher McChalicher
Diagnostic tests in patients with suspected recurrence 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 after completion of standard of care Antibiotics: results from ECOSPOR-III, a randomized, double-blind, placebo-controlled phase 3 trial of SER-109, an investigational microbiome treatment, presenter author: Thomas Louie
The burden of disease associated with recurrence Clostridioides difficile Infection: A Demand-Based Analysis, Principal Author: Rachel Black
In addition, Paul Feuerstadt, MD, will be giving a sponsored talk on Friday, October 1 at 2:00 p.m. – 2:45 p.m. ET, entitled “Perspectives on the Pathogenesis of Recurrence Clostridioides difficile Infection: Insights into the Science of the Microbiome. ”
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 the SER-155
SER-155, an oral consortium of cultured bacteria, is a microbiome therapeutic candidate destined to advance into clinical development. SER-155 is designed using microbiome biomarker data from human clinical data, human cell-based assays and in vivo disease models, with the aim of reducing infection and translocation of antibiotic resistant bacteria in the gastrointestinal tract and modulating host immune responses to decrease GvHD. The rationale for this program is based in part on clinical evidence published by Seres collaborators at Memorial Sloan Kettering Cancer Center showing that allogeneic hematopoietic stem cell transplant (HSCT) patients with reduced commensal microbe diversity are significantly more likely to die from infection. and / or GvHD. SER-155 was developed using Seres’ reverse translational discovery platform to reduce morbidity and mortality from gastrointestinal infections, bacteremia and GvHD in immunocompromised patients, including patients receiving allogeneic HSCT or solid organ transplants.
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 progresses for 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 approval of SER-109 and its status as a premier therapeutic product, timing of a BLA filing, ultimate safety profile of SER-109, ultimate market for SER-109, potential for therapies the microbiome to improve outcomes in immunocompromised patients, the ability of SER-109 to improve the quality of life of patients with rCDI, the potential of microbiome therapies to treat and prevent disease, the timing and results of our clinical studies , the benefits of our collaborations, the ultimate safety and efficacy data for our products, and other statements that are not historical facts .
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 the heading “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 the forward-looking statements contained 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 cause our view to change. These forward-looking statements should not be taken as representing our views as of any date subsequent to the date of this press release.