On April 26, 2023, American biotechnology company Seres Therapeutics announced that the US Food and Drug Administration (FDA) had approved the listing of its oral fecal microbiota drug Vowst (SER-109).
Vowst is made from feces donated by healthy individuals who meet relevant standards after screening. After ethanol treatment, the feces are left with purified bacterial spores of Firmicutes, which can break the vicious cycle of recurrence of Clostridium difficile infection (CDI). The inspiration for this product comes from fecal microbiota transplants (FMT), which strictly collect healthy human feces and transplant the functional microbiota into the patient's body through colonoscopy, enema, or medication.
Before patients undergo fecal microbiota transplantation surgery, hospitals need to conduct strict examinations on the health status of both the patient and the fecal microbiota provider. The process is very complex, and there are situations where different hospitals have varying levels of testing. However, now that oral fecal microbiota drugs are available, biological companies can produce them under strict quality standards, improving the safety and stability of the products. From the perspective of patients, in addition to avoiding registration and hospitalization A series of complicated procedures such as surgery are also more convenient in the treatment process Regarding the advantages of oral fecal microbiota drugs, Professor Xin Yi analyzed, "Due to the matching problem between patients and donors involved in fecal microbiota transplantation, it cannot be guaranteed that every surgery will be successful. After the emergence of oral drugs, if relevant biological companies can provide multiple formulations of capsules for patients to choose or try, it can also improve treatment efficiency and reduce patient pain during surgery to a certain extent
In recent years, fecal microbiota transplantation has been increasingly used to treat severe intestinal diseases, especially infections caused by Clostridium difficile. According to the 2023 edition of the Journal of Guangdong Pharmaceutical University, Clostridium difficile infection is a potentially fatal disease that can cause diarrhea and severe colon infections. Approximately 15000 to 30000 people die from this disease every year in the United States.
So is oral fecal microbiota medication a better choice for treating Clostridium difficile infection, and can it replace the current methods of fecal bacterial transplantation treatment?
Professor Xin Yi stated that it is still too early to draw a conclusion. Fecal bacteria transplantation can be administered directly through enema, resulting in a lower mortality rate and stronger targeting of bacteria. However, oral medication that passes through the stomach and intestines over long distances may have an impact on the survival rate and treatment effectiveness of bacteria
Secondly, drugs need to have a certain degree of universality in large-scale production to meet the needs of more people. That is to say, compared to current fecal microbiota transplantation surgery, drugs may not be able to adapt to personalized characteristics. Additionally, from an operational perspective, if patients take drugs themselves and experience adverse reactions in extremely special circumstances, can they receive timely attention from professional doctors like during fecal microbiota transplantation surgery in a hospital Help is also a problem
The emergence of oral fecal microbiota drugs is of great significance
Nevertheless, Professor Xin Yi still stated that the emergence of oral fecal microbiota drugs is of great significance. Firstly, it can provide more treatment options for some refractory enteritis and immune imbalances caused by changes in the microbiota in clinical practice. Secondly, from a larger perspective, the emergence of oral fecal microbiota drugs is also a driving force for the transformation of public health concepts - feces actually contain essential organisms and substances for our body. If the dependency relationship between the human body and these microorganisms is broken, the human body can tolerate Easy to get sick. Therefore, it is also worth exploring how we can better utilize bacteria and other microorganisms in the human body in the future
This drug is used to prevent recurrent Clostridium difficile infection in adults over 18 years old who have been treated with antibiotics. FDA announcement shows that Vowst, the world's first oral fecal microbiota drug, is administered orally with four capsules per day for three consecutive days. At an investor conference call held on April 27th local time, Seres revealed that the price of Vowst was $17500 per treatment.
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