OpenBiome and the University of Minnesota collaborate to give Microbes to those in Need

In Cambridge, Massachusetts a logistical partnership has formed between OpenBiome and the University of Minnesota’s Microbiota Therapeutics Program to ensure that patients with recurrent C. difficile infections have access to fecal microbiota transplantation (FMT) until an FDA-approved alternative is available. OpenBiome will distribute preparations of intestinal microbiota manufactured by the University of Minnesota under the guidance of gastroenterologist Alexander Khoruts, MD and microbiologist Michael Sadowsky, PhD.

C.difficile Condition

C.difficile is short for clostridium difficile and is responsible for around 170,000 infections a year outside of healthcare settings. Despite many people carrying these bacteria in their large intestine asymptomatically they can cause mild to severe infections resulting in diarrhea and severe dehydration.1  

This condition is recurring in 20-30% of cases after the first infection and 50% after the first instance of recurring. The condition can be life threatening in many people and so there is a vested interest in creating a permanent solution. As it currently stands C.difficile infections are mainly treated with antibiotics and in more extreme circumstances with immunotherapy such as intravenous immunoglobulin G or prednisolone to control the immune reaction. The antibiotics can go all the way up severity to intravenous vancomycin. However, there are times where antibiotics prove ineffective and alternative therapies must be done. 

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 FMT and Non-Antibiotic Treatments

An example these alternative therapies is fecal microbiota transplantation. This therapy makes oral administrable medications made from the freeze dried feces of the donor. This, once it enters the system, has the opportunity to grow and develop in the receiver’s digestive system and hopefully outcompete the C.difficile.

However, FMT is not available everywhere. The bacterial infection harms its host with TcdA and TcdB toxins and so Bezlotoxumab is an example of an immunotherapy against these toxins. Bezlotoxumab is a fully humanized monoclonal antibody against C. difficile toxin B and indicated for prevention of rCDI in at-risk patients.

 Related Article: Scientists Identify Antidotes To Overcome Collateral Damage of Antibiotics on Gut Microbiota

Future C.difficile Treatments

“An FDA-approved microbiota-based therapy will be a huge step forward for patient care and the microbiome field,” said Julie O’Brien, OpenBiome’s Executive Director.  

Investigational treatments, made available to patients outside of clinical trials through an FDA policy enacted in 2013, have served as a bridge to FDA-approved alternatives to FMT. These alternatives are expected to become available to patients in 2023. OpenBiome expects to begin shipping FMT preparations manufactured by the University of Minnesota to its FMT referral network in the second half of 2022 and to continue using its own inventory for emergency treatments.  

The collaboration with the University of Minnesota will help OpenBiome fulfill its mission of providing safe access to FMT. Its nonprofit microbiota bank was founded in 2013 to provide an immediate solution to the healthcare need of treating patients with recurrent C. difficile who had failed standard antibiotic regimens.  

OpenBiome and the University of Minnesota are both 501c3 non-profits and are an excellent example of charity in the biotechnology industry. The power of simply increasing the access that the public has to a technology is often overlooked when compared to the creation of new technologies. It is likely OpenBiome could do a lot for US C.difficile sufferers.

Author

Eduardo Longoria