Nestlé Health Science and Seres Therapeutics to Present Data on VOWST® (fecal microbiota spores, live-brpk) Capsules at the 2024 Digestive Disease Week (DDW) Annual Meeting
HOBOKEN, N.J. and CAMBRIDGE, Mass., May 15, 2024 — Nestlé Health Science and Seres Therapeutics, Inc. (Nasdaq: MCRB) today announced the presentation of data on VOWST (fecal microbiota spores, live-brpk) at the upcoming 2024 Digestive Disease Week (DDW 2024) being held in Washington, D.C. and virtually from May 18-21, 2024. VOWST is the first and only U.S. Food and Drug Administration (FDA)-approved orally administered microbiota-based therapeutic to prevent recurrence of Clostridioides difficile infection (CDI) in adults following antibacterial treatment for recurrent CDI (rCDI).
VOWST is not indicated for the treatment of CDI. Please see the full Indication, Limitation of Use, and Important Safety Information below.
The data presented will include an integrated analysis on the safety and efficacy of VOWST from the ECOSPOR III and ECOSPOR IV studies, as well as an economical modeling of treatment with VOWST compared to treatment with fecal microbiota, live-jslm. Both posters will be presented in Hall A of the Walter E. Washington Convention Center on May 18th from 12:30PM to 1:30PM ET. The full results of both studies were previously published in the New England Journal of Medicine1 in January 2022 and JAMA Network Open2 in February 2023, respectively.
“Alongside our collaboration partners at Seres Therapeutics, tackling the burden of recurrent C. difficile infection continues to be our main goal as we bring VOWST to appropriate patients,” said Moreno Perugini, President of Active & Medical Nutrition, U.S. & President of Global Pharmaceutical Therapies. “We look forward to presenting these data at DDW which reinforce VOWST as an impactful, well-tolerated and effective treatment.”
Presentation Titles and Summaries:
- Abstract Title: Clinical and Economic Outcomes of Microbiome Therapy for Preventing Recurrence in Recurrent Clostridioides Difficile Infection (CDI) in the US: Comparison of Fecal Microbiota Spores, live-brpk (Formerly SER-109) vs. Fecal Microbiota, live jslm
Session Title: Clostridioides Difficile Colitis: Pathogenesis, Diagnosis, Management and Therapy
Session Type: Poster Session
Session Date and Time: May 18, 2024, from 12:30 PM to 1:30 PM EDT (UTC –4)
- Abstract Title: Safety and Efficacy of Fecal Microbiota Spores, live-brpk (formerly SER-109) in Older Patients with Recurrent Clostridioides difficile Infection: Findings from an Integrated Analysis of Phase 3 Trials
Session Title: Clostridioides Difficile Colitis: Pathogenesis, Diagnosis, Management and Therapy
Session Type: Poster Session
Session Date and Time: May 18, 2024, from 12:30 PM to 1:30 PM EDT (UTC –4)
INDICATION AND IMPORTANT SAFETY INFORMATION FOR VOWST
INDICATION
VOWST (fecal microbiota spores, live-brpk) is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI.
Limitation of Use: VOWST is not indicated for treatment of CDI.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Transmissible infectious agents: Because VOWST is manufactured from human fecal matter, it may carry a risk of transmitting infectious agents. Report any infection that is suspected to have been transmitted by VOWST to Aimmune Therapeutics, Inc. at 1-833-246-2566.
Potential presence of food allergens: VOWST may contain food allergens. The potential to cause adverse reactions due to food allergens is unknown.
ADVERSE REACTIONS
The most common adverse reactions (reported in ≥5% of participants) were abdominal distension (31.1%), fatigue (22.2%), constipation (14.4%), chills (11.1%), and diarrhea (10.0%).
To report SUSPECTED ADVERSE REACTIONS, contact Aimmune Therapeutics at 1-833-AIM-2KNO (1-833-246-2566), or the FDA at 1-800-FDA-1088, or visit www.fda.gov/MedWatch.
DRUG INTERACTIONS
Do not administer antibacterials concurrently with VOWST.
Please see Full Prescribing Information and Patient Information
About Recurrent C. difficile Infection (rCDI)
Recurrent C. difficile infection is a gastrointestinal infection caused by C. difficile bacteria. rCDI is linked to dysbiosis of the gastrointestinal microbiome and is associated with increased morbidity and mortality. CDI has been characterized as an Urgent Health Threat by the Centers for Disease Control and Prevention (CDC). rCDI results in a substantial burden on the healthcare system3 with the average rCDI-related annual costs per patient at approximately $43K.4
About Nestlé Health Science
Nestlé Health Science, a leader in the science of nutrition, is a globally managed business unit of Nestlé. We are committed to redefining the management of health, offering an extensive portfolio of science-based consumer health, medical nutrition, pharmaceutical therapies, and vitamin and supplement brands. Our extensive research network provides the foundation for products that empower healthier lives through nutrition. Headquartered in Switzerland, we have more than 12,000 employees around the world, with products available in more than 140 countries. For more information, please visit www.nestlehealthscience.us.
About Seres Therapeutics
Seres Therapeutics, Inc. (Nasdaq: MCRB) is a commercial-stage company developing novel microbiome therapeutics for serious diseases. Seres’ lead program, VOWST®, obtained U.S. FDA approval in April 2023 as the first orally administered microbiome therapeutic to prevent recurrence of C. difficile infection (CDI) in adults following antibacterial treatment for recurrent CDI and is being commercialized in collaboration with Nestlé Health Science. Seres is evaluating SER-155 in a Phase 1b study in patients receiving allogeneic hematopoietic stem cell transplantation. For more information, please visit www.serestherapeutics.com.
About Digestive Disease Week
Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 18-21, 2024. The meeting showcases more than 4,400 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org
Forward-Looking Statements of Seres Therapeutics, Inc.
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 degree of market acceptance of VOWST; and other statements which are not historical fact.
These forward-looking statements are based on Seres’ 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 Seres 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: Seres has incurred significant losses, is not currently profitable and may never become profitable; Seres’ need for additional funding; Seres limited operating history; Seres unproven approach to therapeutic intervention; Seres reliance on third parties and collaborators to conduct their clinical trials, manufacture our product candidates and develop and commercialize our product candidates, if approved; the unknown degree and competing factors of market acceptance for VOWST; the competition Seres will face; Seres’ ability to protect our intellectual property; and Seres’ ability to retain key personnel and to manage our growth. These and other important factors discussed under the caption “Risk Factors” in Seres' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC), on May 8, 2024, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While Seres may elect to update such forward-looking statements at some point in the future, Seres disclaims any obligation to do so, even if subsequent events cause Seres’ views to change. These forward-looking statements should not be relied upon as representing Seres ’views as of any date subsequent to the date of this press release.
References:
1. Feuerstadt P, Louie TJ, Lashner B, et al. SER-109, an Oral Microbiome Therapy for Recurrent Clostridioides difficile Infection. N Engl J Med. 2022;386:220-9. DOI: 10.1056/nejmoa2106516
2. Sims MD, Khanna S, Feuerstadt P, et al. Safety and Tolerability of SER-109 as an Investigational Microbiome Therapeutic in Adults With Recurrent Clostridioides difficile Infection: A Phase 3, Open-Label, Single-Arm Trial. JAMA Network Open. 2023;6(2):e2255758. DOI: 10.1001/jamanetworkopen.2022.55758
3. Rodrigues R, Barber GE, Ananthakrishnan AN. A Comprehensive Study of Costs Associated With Recurrent Clostridium difficile Infection. Infect Control Hosp Epidemiol. 2016;38:196-202. DOI: 10.1017/ice.2016.246
4. U.S. Bureau of Labor Statistics. CPI Inflation Calculator. U.S. Bureau of Labor Statistics. Published 2022. https://www.bls.gov/data/inflation_calculator.htm. CPI inflation adjusted to March 2023.
Seres IR and PR Contact
Nestlé Health Science PR Contact:
Christina Ferzli
Christina.Ferzli@us.nestle.com