There are many over-the-counter probiotic food additions that one can eat, and now the FDA has approved the first oral microbiome to be used as a therapeutic.
The agency has greenlighted Seres Therapeutics’ live microbiome capsule Vowst, previously coded SER-109, to prevent recurrence of Clostridioides difficile infection, a potentially deadly disease.
While antibiotics are mostly effective at knocking back C. difficile, they also disrupt the gut microbiome ecosystem. For its part, Vowst introduces purified Firmicutes spores, a type of “good” microbiome, to outcompete C. difficile and therefore restore gut health.
The idea originated from fecal transplants, which have long been used in clinical practice with little FDA oversight. Vowst, though it’s also developed from microbiota spores in donor’s poop, represents a standardized therapy that has undergone rigorous FDA evaluation. And it’s the first FDA-approved oral microbiome therapy.
Citing CDC data, Seres estimates there will be about 156,000 recurrent C. difficile cases in the U.S. in 2023. In a phase 3 trial dubbed ECOSPOR III, Vowst beat placebo in reducing the risk of recurrent C. difficile infections. Eight weeks after dosing, 12% of patients in the Vowst group and 40% in the placebo arm experienced recurrence.
Vowst marks Seres’ first product. But the Flagship Pioneering portfolio company will have marketing help from food giant Nestlé through a co-commercialization, profit-sharing deal signed in 2021.
Nestlé Health Science already has a gastroenterology sales force detailing several gut health brands, including the Fiber Choice line of probiotic and fiber supplements and a prescription drug called Zenpep, which is for people who can’t digest food properly because of a lack of pancreatic enzymes. With Wednesday’s FDA approval, the sales team will promote Vowst as well.
Nestlé has a “leading GI infrastructure, which was highly attractive to us,” Seres CEO Eric Shaff said in an interview ahead of the approval.
But Nestlé’s recently launched strategic review—and likely sale—of peanut allergy drug Palforzia has raised questions about the Swiss conglomerate’s overall commitment to pharmaceuticals. Nestlé obtained Zenpep as a divestment from the AbbVie-Allergan merger in 2020 and then put down $2.1 billion to acquire Palforzia developer Aimmune Therapeutics as a foray into pharma.
Nestlé’s relationship with Seres runs longer; the two penned a strategic collaboration on microbiome-based therapies outside North America back in 2016. The companies added Vowst in the U.S. and Canada in mid-2021.
Seres and Nestlé remain committed to each other, Shaff said. In a statement to Fierce Pharma, a Nestlé spokesperson said the strategic review on Palforzia doesn’t apply to the overall Aimmune unit. The company is focused on GI and metabolic disorders within the nutritional pharma space, the spokesperson said, adding that Vowst “fits perfectly within this GI focus.”
“In commercializing [Vowst], Nestlé Health Science will tap into significant synergies with its existing GI and medical nutrition expertise, including a vast network and strong relationships with specialist physicians and key hospitals,” the spokesperson said.
Seres and Nestlé have set up a joint committee to take care of Vowst’s rollout, Shaff said. Seres is mainly responsible for manufacturing and has been leading the charge on medical affairs and regulatory filings. For its part, Nestlé mainly contributes its commercial infrastructure, including sales reps and reimbursement capabilities. The manufacturing scale-up, payer conversations and medical education started before the approval, Shaff said.
The two companies face competition from another microbiome-based therapy. Ferring Pharmaceuticals in late 2022 won FDA approval for Rebyota, a one-time, enema-delivered microbiome therapy for C. difficile. By comparison, Vowst is taken orally one daily for three consecutive days.
Having additional options for difficult-to-treat C. difficile is good for patients, Shaff said. But he also argued that Vowst’s oral route of administration differentiates it from the competition.
Compared with a drug administered by a healthcare provider, having a therapy that can be taken at home is more scalable, he said.
“The physicians that we’ve spoken with, what they tell us is that they’ve been waiting for something which is effective, which is well-tolerated and which is oral,” Shaff said.
Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research said in a statement: “The availability of a fecal microbiota product that can be taken orally is a significant step forward in advancing patient care and accessibility for individuals who have experienced this disease that can be potentially life-threatening.”