In a world first, an American company Seres has just earned the coveted FDA approval to sell and market a pill that contains donated human fecal matter –– poop. We wrote about the Seres poop pill product in 2016 and it is now a reality.
The use of microbiome therapy, literally transferring healthy human gut microbes from one person to another, is very beneficial to maintain a healthy balance of bacteria in human intestines. In theory you could swallow the poop of your friend’s or a family member, but that just seems gross, and unprofessional. How do you know if their gut biome is good for yours?
Seres, along with its commercial partner Nestle, is hoping to commercialize on the idea, helping people who suffer from gut problems such as Clostridium difficile.
People having a bacteria imbalance in their intestines can be afflicted with this severe intestinal ailment. Clostridium difficile (CDI) is a severe gut infection that can strike people using antibiotics, which wipes out their existing gut bacterial levels. It tends to re-occur. But healthy bacteria from someone else’s poop can give a person suffering from CDI a boost.
The process of transferring faecal bacteria from one person to another is known as a faecal microbiota transplant. Seres’s main competitor is an actual stool bank called OpenBiome.org that provides stool samples of “pure poop” to medical practitioners for microbiota transplants. So why not just get it for free? You have to hand it to scientists for figuring out how to tweak poop.
Seres has earned an FDA approval on VOWST, not indicated for the treatment of CDI but for preventing reoccurrence.
“We are deeply grateful to the patients, caregivers, clinical investigators, and employees who contributed to the discovery, development, and approval of VOWST,” said Eric Shaff, CEO at Seres.
Recurrent CDI represents significant unmet need and is a leading cause of hospital-acquired infection that can result in severe illness and death. Based on data from the US Centers for Disease Control and Prevention (CDC), the companies estimate 156,000 episodes in the US in 2023 alone.
Seres founder Noubar Afeyan, born in Lebanon, is now Canadian and American. He studied at McGill University in Toronto
“Recurrent C. difficile infection is a highly debilitating and life-threatening disease, and antibiotics alone do not address the underlying cause of rCDI, dysbiosis of the gut microbiome,” said Carl Crawford MD, at Weill Cornell Medical College involved in the study. “The approval of VOWST provides an important new oral treatment option for this disease, and I am pleased to now be able to offer this medicine to recurrent CDI patients.”
Nestle, based in Vevey, Switzerland invested $120 million USD in Seres in 2016.
Seres Therapeutics is a microbiome therapeutics company that was founded in 2010 and headquartered in Cambridge, Massachusetts. Seres Therapeutics is a microbiome therapeutics company headquartered in Cambridge, Massachusetts and was founded in 2010 by Noubar Afeyan and David Berry.
Noubar Afeyan is an American-Canadian entrepreneur, inventor, and philanthropist. He is best known for co-founding the biotechnology company Moderna, through his venture capital firm, Flagship Pioneering, and for co-founding humanitarian projects such as Aurora Prize and The Future Armenian. Afeyan was born to Armenian parents in Beirut, Lebanon in 1962.
::Seres
