Nestlé Bets $525M On Seres Therapeutics Microbiome Drug For Infectious Diseases

Author: Vandana Singh | July 01, 2021 11:01am

Seres Therapeutics Inc (NASDAQ:MCRB) has inked a $525-million deal with Nestlé Health Science to commercialize SER-109 if it can win FDA approval.
SER-109 is an oral, live microbiome therapy under development for patients with recurrent C. difficile infection, a leading cause of hospital-acquired infections in the U.S.
The candidate is made up of purified Firmicutes spores, a type of bacteria.
Under the new deal, Nestlé’s global pharmaceutical business, Aimmune Therapeutics, will take the lead on commercialization.
Seres will secure $175 million upfront, plus another $125 million if the candidate gets FDA approval.
The agreement also includes sales target milestones of up to $225 million, and Seres is entitled to 50% of the commercial profits.
In August 2020, Seres announced that SER-109 had met the primary endpoint in Phase 3 ECOSPOR III study, showing a highly statistically significant reduction in the rate of CDI recurrence compared to placebo at eight weeks, with an absolute decrease of 27% and a relative risk reduction of 68%.
In a separate measure, approximately 88% of patients achieved sustained clinical response at week eight.
The drug’s in an ongoing open-label safety study, with results expected in the third quarter. Seres and Nestlé are hoping the efficacy results will support a marketing application filing “once the SER-109 safety database includes at least 300 treated subjects monitored for 24 weeks,” based on feedback from the FDA.
MCRB Price Action: MCRB shares were down 1.93% at $23.39 at last check Thursday.