Saturday, March 21, 2015

Update on OpenBiome

I was curious to know about the progress of the non-profit fecal microbiota transplant (FMT) company OpenBiome since I last visited them on this blog in December 2013. So, I inquired of Mark Smith and James Burgess, who gave this heartening report:

Thanks for checking in! The past year has been a very interesting and rewarding one for us. You wrote the first story ever about OpenBiome and started a media cascade that ended with coverage in the New York Times and beyond. We've experienced rapid growth and are working with over 230 hospitals in 43 states and have provided treatments for over 2800 recurrent C. difficile patients at this point. 

In addition to enabling care for C. difficile patients, we have also worked to support a number of clinical trials investigating the use of FMT for new indications. Many are still in the planning phases or have just recently been approved by the FDA and are preparing to initiate recruitment, but we're supporting studies of FMT in Ulcerative Colitis, Crohn's and IBS. We're also discussing studies for more exotic conditions, although none have moved beyond ideation at this point. There's an awful lot of hype in this space so we've been cautious about moving too quickly. C. difficile remains the only condition that we know benefits from FMT.

Over the past year, we have also been testing and developing an encapsulated formulation that should reduce procedure related costs and risks for treatment of C. difficile, while enabling long term maintenance therapy for the investigation of chronic conditions where a single dose is unlikely to provide lasting benefit. Capsules will also enable more robust blinding during placebo controlled trials.

Looking to the future, the long-term regulation of FMT remains an important open question. We have advocated that stool should be regulated with its own custom screening and processing requirements like blood products, while synthetic cocktails composed of well-defined, pure cultures of bacteria should be regulated as biological drugs. In the long-term, we are confident that this synthetic approach will replace natural stool (certainly for the treatment of C. difficile), but until then we think OpenBiome has an important role to play in the public health system both by enabling care for otherwise intractable cases of C. difficile and supporting research into new applications for FMT. 

Indeed, based on a cost effectiveness study by Ashwin Ananthakrishnan's group at MGH, each FMT saves the healthcare system $17K in direct treatment costs, putting our savings to the system at close to $50 million. However, this assumes FMT is delivered using the traditional directed donor approach rather than the more efficient universal donor model that we employ, so the true savings are likely considerably higher. Carolyn Edelstein has been doing a deeper dive into these numbers and is working with folks at the Harvard School of Public Health to conduct a more realistic assessment. We think these economic consequences should be considered as regulatory decisions are made, especially given that the costs of biologics are likely to be much higher than the material that we provide today for $250 per treatment.

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