USA approves first pill derived from feces – 04/28/2023 – Health

Regulators in the United States have approved for the first time a pill derived from human feces, which a late-stage study has shown can reduce the recurrence of the potentially deadly intestinal infection by C. difficile in adults.

The oral therapy called Vowst was developed by Seres, the Boston-based company backed by global food giant Nestlé and American biotechnology incubator Flagship Pioneering, behind vaccine maker Moderna.

It is part of a new class of microbiome therapies, which aim to restore the balance of living bacteria in patients’ guts to boost their immune system and prevent infections.

C. difficile it is a drug-resistant superbug associated with nearly 30,000 deaths in the US each year and more than $4.8 billion in costs to the US healthcare system.

One in six patients with the infection relapses within eight weeks, a condition known as C. difficile recurrent, according to the Centers for Disease Control and Prevention (CDC).

Seres said approval of the first oral microbiota therapy by the US Food and Drug Administration (FDA) would provide patients with a new tool to fight infections with this bacteria, which cause colon inflammation and diarrhea.

The company said the approval validated the technology platform it is using to develop other microbiome therapies, including one aimed at preventing infections in patients undergoing stem cell transplants.

Eric Shaff, chief executive of Seres, said the therapy marked the beginning of a new era for a microbiome industry that is attracting interest from investors, clinicians and companies.

“This is a technology that’s here now. And I think for us it could be a tipping point for a whole new modality of treating patients,” he said.

W. difficile It is a bacterial infection treated with antibiotics. But the use of these drugs can eliminate much of the microbes in the human system that aid digestion and the immune response, leaving people vulnerable to reinfection.

Fecal transplants using the stool of a healthy donor have become an increasingly common therapy over the last decade, although they are unregulated and have generated safety warnings from the FDA on occasion.

These are usually administered via an enema, although a small number of health centers offer the therapy in research-based pill form.

In November, the FDA issued its first green light for a faecal transplant therapy by approving Rebyota, a product developed by Swiss pharmaceutical company Ferring that also targets C. difficile. The product is prepared from the feces of a qualified donor and administered rectally in a fecal transplant, unlike the pill developed by Seres.

Joseph Thome, an analyst at Cowen, said the oral therapy developed by Seres would be more convenient to administer than Rebyota.

“The Seres therapy could be really important — the consultants we spoke to estimate around 150,000 recurrent infections with C. difficile in 2023,” Thome said, adding that Vowst could generate peak sales of $850 million a year in the US.

Vowst is made by treating human feces with ethanol, a process that kills many of the viruses and bacteria that can cause infections. But it leaves behind spores produced by a type of bacteria called Firmicutes, which compete with the bacteria C. difficile in the intestine and hinders its multiplication and release of toxins that trigger diarrhea and inflammation.

A late-stage study showed that Vowst reduced the recurrence of C. difficilewith 88% of subjects having no repeat infection at eight weeks, compared with 60% of participants receiving placebo.

Alexander Khoruts, professor of medicine at the University of Minnesota School of Medicine, said the approval of the Seres pill could mark the beginning of a new class of therapeutics after a decade of hype about the potential of microbiome medicine.

But he said much follow-up research is needed to prove the pill works in a real-world setting and can match the effectiveness of alternatives.

Khoruts said, “It’s the world’s first FDA-approved poop pill. However, there may still be potential for less expensive, nonprofit alternatives. Importantly, research still needs to be done to understand the performance of all poop-based products. in long-term microbiota”.

Nestlé Health Science, the Nestlé unit specializing in food nutrition that owns a 6% stake in Seres, has agreed to jointly market the new therapy in the US and Canada. Nestlé will make a partial payment of US$125 million to Seres upon FDA approval and the companies will split the drug’s profits equally.