Seres Therapeutics, Inc. (Nasdaq: MCRB) and Nestlé Health Science are proud to announce findings from a Phase 3 Development Program analysis for VOWST™ (fecal microbiota spores, live-brpk), the first and only FDA-approved orally administered therapeutic to prevent recurrence of C. difficile infection in adults after antibacterial treatment. This ground-breaking data was featured as a “late-breaker” Emerging Science presentation at the prestigious American Society of Microbiology (ASM) Microbe 2023 held in Houston, TX.
The ECOSPOR III and IV Phase 3 studies revealed an intriguing discovery about the gut microbiome in patients with recurrent C. diff. Upon further evaluation, it was found that both first recurrence patients and those with multiple recurrences shared a similarly lower microbiome diversity at baseline.
However, following treatment with VOWST, a significant increase in both microbiome diversity and secondary bile acid levels was observed – resulting in less favourable conditions for C. difficile growth.1 This is an exciting finding, as medical professionals continue to search for more effective treatments for individuals struggling with recurrent C. diff.
Results from the Phase 3 ECOSPOR III and ECOSPOR IV studies indicate that it is not only first-time C. difficile infection recurrence patients who suffer a lapse of microbiome diversity, but multiple recurrence patients as well. Luckily, following treatment with VOWST, researchers have observed a rapid and pronounced increase in microbiome diversity in just one week. Lisa von Moltke, M.D., Chief Medical Officer of Seres, commented on the exciting results.
Recurrent Clostridioides difficile infection (CDI) is a leading cause of hospital-acquired infection that has a devastating impact – severe illness and death – yet remains an unmet medical need. According to the U.S. Centers for Disease Control and Prevention (CDC), the number of recurrent CDI episodes is expected to increase to 156,000 in the U.S. in 2023, necessitating further research and measures to tackle this challenge.
About Recurrent C. difficile Infection (rCDI)
Recurrent C. difficile infection (rCDI) is not just a nuisance, it carries a heavy burden on healthcare systems as well as the individuals suffering from it. In fact, the Centers for Disease Control and Prevention (CDC) has designated rCDI as an Urgent Health Threat. The annual cost for treating one person with this debilitating illness runs up to an estimated $43,000! Fortunately, studies have found that restoring a proper balance of gut bacteria (dysbiosis) can help manage rCDI.
About Seres Therapeutics
Seres Therapeutics, Inc. (Nasdaq: MCRB) is revolutionizing the treatment of serious diseases with its cutting-edge microbiome therapies. In April 2023, the company made history with the FDA approval of VOWST™, their flagship therapy, which is the first orally administered microbiota-based treatment to prevent recurrence of C. difficile infection (CDI) in adults following antibacterial treatment.
Seres is also making progress with research on SER-155, being tested in a Phase 1b study in patients receiving allogeneic hematopoietic stem cell transplantation, as well as other microbiome therapies for ulcerative colitis. The company is partnering with Nestlé Health Science to bring these innovative therapies to the public.
About Nestlé Health Science
At Nestlé Health Science, we are redefining the management of health through a portfolio of science-based consumer health, medical nutrition, pharmaceutical therapies, and vitamin and supplement brands. Our commitment to the science of nutrition materializes through the research network powering healthier lives through nutrition. We are a globally managed business unit of Nestlé, and are proud to have 12,000+ employees across 140+ countries, bringing our products to the world.
Forward-Looking Statements
VOWST is poised to revolutionize the way patients with recurrent Clostridioides difficile (rCDI) infections are managed with its groundbreaking microbiome diversity assessment technology. Through its VOWST Voyage program, the company is positioned to unlock captivating opportunities for rCDI patient access to more timely and better informed decisions consistent with current best practices. The potential of this technology is tremendous, and we remain confident in its ability to change the quality of life of patients struggling with rCDI.
At VitalOxide Wellness Solutions Technologies (VOWST), we have a clear mission — to develop therapeutic interventions that improve quality of life. However, our path forward is not without risk. We have incurred significant losses and may never become profitable. Our limited operating history also means we are highly dependent on third parties and collaborators to conduct our clinical trials, manufacture our product candidates and develop and commercialize our products should they be approved.
And of course, the unknown degree of market acceptance for VOWST, plus potential competition we will face, will all impact our success. Add to that our ability to protect our intellectual property and retain key personnel, and it’s clear that our future success is by no means assured. Even with these uncertainties, we remain focused on our mission and remain confident in our ability to make a positive impact.