The Challenges of Moving from Research to ClinicDr. Colleen Cutliffe, CEO and Co-Founder of Whole Biome stated that she was inspired to begin research in the microbiome when her daughter was born 7 weeks premature and had difficulty thriving and developed IBD. Dr. Cutliffe discussed the challenges of moving from research to clinic with the many challenges of translating data from in vitro studies and animal models, such as germ-free mice, to humans. “We need to develop the criteria that can be used to move from animal models to humans.
The databases used to match up sequencing results still need to be populated with the sequences and data from the microbial species that make up the microbiome communities.
Moving Microbiome Products Through Clinical TrialsDr. Larry Weiss, Chief Medical Officer of AOBiome, a startup focusing on the skin microbiome, spoke about returning our skin microbiome into balance with ancestral or keystone commensal organisms that help to maintain skin health. AOBiome, one of the first companies to commercialize microbiome products has focused initially on consumer products, but at the same time is moving products through clinical trials. He spoke of acne and eczema being the skin equivalent of IBD. “These are western culture symptom’s resulting from a chemically induced (ie soaps) dysbiosis of the skin microbiome. Nitrogen fixing microbes can bring the skin microbiome into balance and help alleviate acne and eczema.
Using Microbiome Treatments To Help Patients Become Disease FreeSeres Health, a microbiome startup in Boston is quickly moving through clinical trials to treat Clostridium Difficile (C. diff) infections. Bacteroides typically comprises 95% of bacteria species in the human gut, patients with C. diff have low or no Bacterioides detectable. Dr. David Cook, Chief Scientific Officer, stated that they were using purified spores derived from human stool to formulate their treatment of C. diff. He stated that “spores are resilient so you can treat to kill unwanted organisms so that transfer of these key organisms is safe.” In a Phase 1b/2 study, 97% of patients were disease free 8 weeks after treatment. Sere has 3 patents issued in the treatment of C. diff using microbiome treatments.
Microbiome-based Drugs and the Transfer of BacteriaNot all microbiome based drugs include the transfer of bacteria from one organism to another. Dr. Ward Petersen, President and Co-Founder of Symberix Inc. noted they identified an enzyme from gut bacteria that is responsible for the toxic side-effects of some NSAIDS pain relievers and cancer drugs. These drugs can elicit the bacteria to over produce B-Glucoronidase, causing diarrhea in patients taking these drugs. Using mouse models, Symberix scientists were able to demonstrate reduction in B-Glucoronidase reduced the symptoms of diarrhea caused by NSAIDS and cancer drugs. They now have an early stage drug at lead optimization aimed at alleviating this drug induced diarrhea. Dr. Petersen also posed this question “Can this [Symbeirx] drug rescue other drugs that have been shown to be effective but have a side effect of diarrhea?” In other words, will advancing knowledge of the microbiome help to alleviate some of the side effects seen with otherwise efficacious drugs, thus allowing wider use of those drugs.
An Alternative to Seeking Venture Capital: CrowdsourcingWhile most companies are seeking venture capital and/or investment from pharmaceutical companies, uBiome has taken a different route through crowdsource funding. Dr. Jessica Richman, CEO of uBiome noted that they had raised $350,000 in financing by providing private citizens the opportunity to have their microbiome sequenced for $100. This is the largest citizen science crowd funding project in history! Their clients can choose to participate in the uBiome research project and see how their microbiome compares to others participating in the project. While no diagnosis is provided, people have the opportunity to see how their microbiomes compare to the public at large. uBiome is collecting key data from their clients. . They have the largest microbiome dataset in the world with 3,000 people, 6,000 samples submitted from people in over 40 countries. They are then able to use that data in research projects with institutions such as Harvard University, Columbia University, Johns Hopkins and some Fortune 500 companies. uBiome has plans to open a clinical lab this month at which point they will start providing diagnosis to medical professionals.
Moving Treatments into the Clinic: Microbiome Research and Animal Research ModelsAs this conference demonstrates, while there is still much to learn about the microbiome, there is sufficient knowledge now to start moving some treatments into the clinic and approved products and to provide microbiome diagnosis. Scientist continue to seek out the best research models for microbiome research, these translational research models provide the key insights to developing lifesaving drugs and treatments.
To learn more about translational research models for microbiome research, visit the Translational Microbiome Research Forum.