- Food and beverage company Nestlé is expanding its collaboration with Massachusetts-based Seres Therapeutics, placing a bigger bet on an experimental drug that regulates microbes in the body to treat a prominent kind of infection.
- The health science unit at Nestlé may pay more than $500 million to secure commercialization rights in the U.S. and Canada for SER-109, a spore-filled capsule that targets the microbiome. SER-109 is meant for patients who have recurrent infections from Clostridioides difficile, or C. diff, a leading cause of hospital-acquired infections in the U.S.
- Nestlé Health Science already had rights outside of those markets because of a four-drug deal that was inked in 2016. Under the expanded agreement, Seres is responsible for development costs in the U.S. prior to commercialization, while Nestlé would take the lead in marketing. Nestlé has agreed to pay Seres $175 million up front, another $125 million upon Food and Drug Administration approval, and as much as $225 million if certain sales goals are met. Additionally, Seres would get half of future profits.
Nestlé and Seres are looking to cement a leading position in the field of microbiome therapeutics, with SER-109 being a key asset.
Results from a late-stage study released last year found patients taking SER-109 were significantly less likely to see their C. diff infections return. Seres plans to use the study to seek FDA approval after at least 300 patients have been treated with the drug and monitored for 24 weeks to satisfy the agency’s requirements. The pivotal study included 182 patients who randomly received either SER-109 or placebo, and research is continuing now in an "open-label" phase, meaning all patients have access to SER-109.
Patients most often acquire C. diff infections after taking antibiotics, which, in addition to eliminating harmful germs, can also wipe out the healthy bacteria the body needs to function. SER-109 is supposed to "repopulate" the microbiome in the gut with purified spores.
The promise of microbiome-targeting therapies has led to the creation of multiple drug companies, among them Finch Therapeutics and Rebiotix. Finch has said its treatment for recurrent C. diff infections, known as CP101, succeeded in the first of two planned pivotal trials.
Rebiotix, meanwhile, is in late-stage testing with its drug, RBX2660.
In addition to C. diff, Seres is testing microbiome therapies for conditions including ulcerative colitis, a chronic inflammatory bowel disease. The company expects to announce high-level results from a mid-stage study of its drug SER-287 for mild-to-moderate ulcerative colitis soon.
In 2016, Nestlé gained commercialization rights outside the U.S. and Canada to SER-287 and SER-301 for irritable bowel disease and SER-262 for C. diff, as well as SER-109. In the latest announcement, Nestlé said it plans to use its Aimmune Therapeutics arm to sell SER-109, should the drug win approval.