The US Food and Drug Administration (FDA) recently approved a new type of medication based on gut microbes, or “microbiome”, for the first time. The therapy is called “SER-109” and is manufactured by the US company Seres Therapeutics. It is designed to prevent recurrence of Clostridioides difficile (C. diff) infections, which can cause diarrhea, seizures, and are difficult to treat due to antibiotic resistance.
In the US, over 15,000 people die each year from this disease. Seres conducted clinical trials with over 200 patients who had recurrent C. diff infections and received four capsules per day for three days. Eight weeks after treatment, only 12% of those treated with SER-109 experienced a recurrence, compared to 40% of those in the placebo group. The therapy works by delivering healthy gut microbes to the colon, providing better treatment outcomes than placebo.
Microbiome-based medication is being developed to harness the power of gut microbes that live within our bodies. These microbes can cause various diseases when the balance is disrupted by lifestyle habits. Microbiome-based products have been widely used as health supplements and cosmetics, but they are now being expanded to treat diseases.
Both domestic and international pharmaceutical companies are utilizing gut microbes to develop treatments for colorectal cancer, breast cancer, and various other cancers, in addition to colon-related diseases. According to consulting firm GlobalData, more than 330 microbiome-based medications are currently under development. Market research company Grand View Research predicts that the global microbiome-based medication market will grow from $114.16 million in 2021 to $1.0668 billion in 2030.
Microbiome-based medication for cancer
Swiss company Ferring Pharmaceuticals received FDA approval for “Rebiotix” as the first microbiome-based therapy in December 2020. Rebiotix is also a C. diff infection therapy that involves inserting the medication into the patient’s anus. The medication is processed using healthy microbes taken from the feces of a healthy individual.
Many pharmaceutical companies are currently conducting clinical trials for microbiome-based treatments for various diseases, including asthma and atopy. French company Enterome Bioscience is developing a therapy for Crohn’s disease, an inflammatory bowel disease, with Japanese partner Takeda. This therapy works by inhibiting the ability of gut microbes to cause inflammation and treat Crohn’s disease.
US company Vedanta Biosciences is developing a therapy for ulcerative colitis and allergies. Microbes can control inflammation and improve immune responses, making them a promising tool for treating various diseases.