The U.S. FDA has approved its first fecal microbiota treatment. Rebyota (fecal microbiota, live-jslm), from privately held Ferring Pharmaceuticals Inc., is now approved to prevent recurring Clostridioides difficile infection (CDI) in adults. The Nov. 30 approval came about two months after the FDA’s Vaccines and Related Biological Products Advisory Committee voted 13-4 to support the microbiome therapy’s effectiveness in reducing recurrent CDI in adults after antibiotic treatment for recurrent CDI.
High hopes rest on manipulating the gut microbiome in order to treat a multitude of disorders. Clinical validation for the idea has come from the success of fecal microbiome transplants to treat chronic Clostridium difficile infections. Such transplants are in clinical trials to treat other gastrointestinal disorders, and more targeted methods to manipulate the microbiome are being developed as well, not just for infections, but in a multitude of other indications. Targeting the gut microbiome may turn into a way to alleviate inflammatory bowel disease, food allergies, and even psychiatric conditions.
Two new studies now have uncovered fungal DNA in tumors throughout the body and endeavor to characterize the cancer mycobiome. Both studies were published in the Sept. 29, 2022, online issue of Cell. Although the association between cancer and individual microbes has long been explored, recent attention has focused on the whole human microbiome.
In a study comparing the antibody repertoire of individuals with severe myalgic encephalopathy/ chronic fatigue syndrome (ME/CFS) to that of healthy controls, the majority of individuals with CFS showed antibody responses to specific microbiome proteins. Such responses were largely absent in healthy controls, implicating immune reactions to the microbiome in the development of ME/CFS.
The race to become the first microbiome-based therapy to reach the market continues between two companies. A positive view by the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee on Sept. 22 for RBX-2660 in preventing recurrent Clostridium difficile infection kept Ferring Pharmaceuticals Inc.’s microbiota-based live biotherapeutic moving forward.
Eurekare SA, a technology commercialization and investment firm, has opened the doors to the first of a number of biotech “studios” it is setting up to hothouse synthetic biology and microbiome companies formed around intellectual property sourced from universities across Europe. It’s the most recent step forward in Eurekare’s ambition of creating a pan-European network for identifying, selecting and nurturing high quality European science in these two fields, which in the opinion of the firm’s founders, is at the same time of very high quality and seriously under-exploited.
Microbiome specialist Enterome SA has out-licensed its lead human hormone mimetic, EM-1010, to Nestlé Health Sciences SA, in a deal that underlines the potential of its approach to generating novel drugs from proteins expressed by gut bacteria. EM-1010, the first program derived from Enterome’s Endomimics platform, is an orally available molecule that acts by promoting local release of interleukin 10 in the gut, with the aim of reducing inflammation. It is in development for the treatment of inflammatory bowel disease and food allergies and due to enter clinical trials in 2023.
Unveiling further positive data for SER-109 in preventing recurrent Clostridium difficile infection at Digestive Disease Week (DDW) over the weekend, Seres Therapeutics Inc. reiterated plans to file a BLA with the U.S. FDA in mid-2022. Should the FDA accept the application and grant priority review – SER-109 has breakthrough and orphan status – the medicine could be the first microbiome-based therapy to reach the market.
Microbiome-modulating therapies are increasingly being explored to treat a variety of diseases. However, the market is still in its infancy and a lack of solid regulations remains challenging for companies to overcome, speakers at the BioKorea 2022 said May 11.
Microbiome-modulating therapies are increasingly being explored to treat a variety of diseases. However, the market is still in its infancy and a lack of solid regulations remains challenging for companies to overcome, speakers at the BioKorea 2022 said May 11.
