First oral microbiome therapy by Vowst. Will Nestlé be around to help Seres with the launch?
The U.S. Food and Drug Administration (FDA) has recently given the green light to the first oral microbiome to be used as a therapeutic. Seres Therapeutics’ live microbiome capsule Vowst, previously coded SER-109, has been approved by the FDA to prevent the recurrence of Clostridioides difficile infection, a potentially deadly disease.
Clostridioides difficile, commonly referred to as C. difficile, is a type of bacteria that can cause diarrhea, fever, and abdominal cramping. While antibiotics are mostly effective at knocking back C. difficile, they also disrupt the gut microbiome ecosystem, leaving patients at risk of recurring infections. Vowst introduces purified Firmicutes spores, a type of “good” microbiome, to outcompete C. difficile and restore gut health.
The idea for Vowst 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-a
pproved 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 Vowst’s approval by the FDA marks a significant milestone in the development of microbiome-based therapies for gut health. The standardized therapy, which was rigorously evaluated by the FDA, represents a major step forward in treating Clostridioides difficile infection, a potentially deadly disease.
According to Seres, there will be approximately 156,000 recurrent C. difficile cases in the US in 2023, citing CDC data. In a phase 3 trial, Vowst outperformed 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 group experienced a recurrence of the disease.
While Vowst marks Seres Therapeutics’ first product, the company will have the support of Nestlé Health Science in marketing the therapy. In a co-commercialization, profit-sharing deal signed in 2021, Nestlé agreed to help Seres with the launch of Vowst. The food giant already has a gastroenterology sales force that promotes several gut health brands, including the Fiber Choice line of probiotic and fiber supplements and a prescription drug called Zenpep, which is used to treat people who can’t digest food properly due to a lack of pancreatic enzymes. With FDA approval, the sales team will also promote Vowst.
Seres CEO Eric Shaff said in an interview ahead of the approval that Nestlé’s “leading GI infrastructure” was highly attractive to his company. The two companies have a long-standing relationship, having penned a strategic collaboration on microbiome-based therapies outside North America in 2016. They added Vowst in the US and Canada in mid-2021.
First oral microbiome therapy by Vowst. Will Nestlé be around to help Seres with the launch?
Seres and Nestlé have set up a joint committee to oversee the rollout of Vowst, with Seres responsible for manufacturing and leading the charge on medical affairs and regulatory filings. Meanwhile, Nestlé will contribute its commercial infrastructure, including sales reps and reimbursement capabilities. The two companies face competition from another microbiome-based therapy, Rebyota, developed by Ferring Pharmaceuticals, which won FDA approval in late 2022. However, Vowst’s oral route of administration, which differentiates it from Rebyota, is a significant advantage for Seres.
“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,” said Shaff. “Compared with a drug administered by a healthcare provider, having a therapy that can be taken at home is more scalable.”
Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, called the approval of an orally administered fecal microbiota product a “significant step forward” in advancing patient care and accessibility for individuals who have experienced this disease that can be potentially life-threatening.
In conclusion, Vowst’s approval by the FDA represents a major breakthrough in the development of microbiome-based therapies for gut health. With the help of Nestlé Health Science, Seres Therapeutics is well-positioned to launch the therapy and provide patients with a more effective, well-tolerated, and easily accessible treatment option for recurrent Clostridioides difficile infections.
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