Seres Therapeutics, Inc. announced that it has entered into an agreement with Nestlé Health Science to jointly commercialize SER-109, Seres’ investigational oral microbiome therapeutic for recurrent Clostridioides difficile infection (CDI), in the United States (U.S.) and Canada. If approved, SER-109 would become the first-ever FDA-approved microbiome therapeutic.
Under the terms of the agreement, Nestlé Health Science will utilize its global pharmaceutical business Aimmune Therapeutics and will assume the role of lead commercialization party. Seres will receive license payments of $175 million up front, and an additional $125 million upon FDA approval of SER-109. The agreement also includes sales target milestones which, if achieved, could total up to $225 million. Seres will be responsible for development and pre-commercialization costs in the U.S. Upon commercialization, Seres will be entitled to an amount equal to 50% of the commercial profits.
The agreement to co-commercialize SER-109 in the U.S. and Canada represents the expansion of an existing strategic collaboration between the companies. Nestlé Health Science already has commercial rights to Seres’ investigational treatments for CDI and inflammatory bowel disease outside of the U.S. and Canada, and with this expansion, Nestlé Health Science becomes Seres’ global collaborator in SER-109.
A leading cause of hospital-acquired infections in the U.S., CDI is associated with debilitating diarrhea and claims the lives of more than 20,000 Americans each year. SER-109 is comprised of purified Firmicutes spores, based on their modulatory role in the life cycle of C. difficile and disease pathogenesis. The bacterial consortium in SER-109 rapidly repopulates the microbiome in the gut to produce compositional and functional changes that are critical to a sustained clinical response.
“Nestlé Health Science has been a terrific collaborator in our quest to develop a new treatment option for patients suffering from recurrent C. difficile infection, and their support over the past few years has been critical in advancing SER-109 to address this unmet need,” Seres Therapeutics CEO, Eric Shaff, said. “We conducted a competitive process to select a collaborator for SER-109. As we prepare for potential approval and commercialization, we are eager to embark side-by-side on our next phase with a company that believes as fervently as we do in the potential of this transformative approach to reduce the recurrence of CDI.”
“We are excited to expand our existing collaboration with Seres Therapeutics at this pivotal time, given the promise SER-109 holds for patients trapped in the debilitating cycle of recurrent C. difficile infection,” CEO of Nestlé Health Science, Greg Behar, added. “Nestlé Health Science is focused on the fast-developing areas of gut health, food allergies and metabolic health within our global pharmaceutical business, Aimmune Therapeutics. We look forward to leveraging Aimmune’s existing, fully integrated commercial infrastructure and capability to launch this important medicine, once approved.”
Nestlé Health Science continues to make significant investments in innovation while leveraging leading-edge science. Its pharma arm, Aimmune Therapeutics, has a strong presence in the field of gastroenterology, allowing it to lead the commercialization of SER-109 while providing Seres the ability to retain a strategic role and actively participate in the launch.
SER-109 Clinical & Regulatory Milestones
- In August 2020, Seres announced that SER-109 had met the primary endpoint from the pivotal Phase 3 ECOSPOR III study, showing a highly statistically significant reduction in the rate of CDI recurrence compared to placebo at 8 weeks, with an absolute reduction of 27% and a relative risk reduction of 68%. In a separate measure, approximately 88% of patients achieved sustained clinical response at week 8.
- The Company expects that the ECOSPOR III efficacy results should support a BLA filing as a single pivotal trial once the SER-109 safety database includes at least 300 treated subjects monitored for 24 weeks, based on feedback from the FDA.
- A SER-109 open-label study is ongoing and continues to contribute to the SER-109 safety database. Completion of target enrollment is anticipated in Q3 of 2021.
Responsibility for oversight of activities to support SER-109 will be governed by a Joint Steering Committee composed of an equal number of members from each company. Seres is responsible for the manufacturing and supply of SER-109 for all geographies contemplated in the collaboration in addition to ex-North America. Seres will lead medical affairs activities pre-launch and Aimmune Therapeutics will lead commercialization and medical affairs activities post-launch.