Clinical OMICS

JUL-AUG 2019

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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16 Clinical OMICs July/August 2019 www.clinicalomics.com One FSM candidate, CP101, has been given breakthrough therapy designation for the treatment of patients with recur- rent CDI by the U.S. Food and Drug Administration (FDA). CP101 is being evaluated in a Phase II trial named PRISM 3 that is currently enrolling patients. An RSM product, FIN- 524, is an investigational product designed to treat a form of IBD known as ulcerative colitis. This drug, developed in partnership with Takeda Pharmaceutical, is based on the identification of specific strains responsible for driving the promising efficacy observed with fecal microbiota trans- plantation in IBD. Finch's sites go beyond the gut, however. Indeed, the company recently announced that the FDA has granted fast track designation to a product for the treatment of children with autism spectrum disorder (ASD). In a preliminary study, Finch's collaborators at Arizona State University used FSM to treat 18 chil- dren affected by ASD. They found a 77% reduction of gastrointestinal symptoms and a 24% reduction of core ASD symptoms after only 8 weeks of treatment, phenotypes that were sus- tained for two years. Based on these promising initial results, Finch is conducting Phase II trials. When Smith launched OpenBiome, the landscape of CDI treatment changed. Now that he is at Finch Therapeutics, Smith is ready to change the treatment landscapes of many more diseases. "If we could manage this ecosystem and intentionally modu- late the composition of this community," he said, "we could radically impact the drivers of morbidity and mortality." Bacteria to treat the brain There is perhaps no area of microbiome research that gar- ners more attention than the gut-brain axis, with the almost surreal premise that everything from depression to neuro- degenerative diseases could be treated by altering the bac- teria in our intestines. One of the many companies active in the gut-brain field is Axial Biotherapeutics. Like this field, which explores connections between the superior and inferior parts of the body, the company links two distant nodes—the headquarters just outside of Boston, and the research laboratory of Sarkis Mazmanian, Ph.D., a professor at the California Institute of Technology and a co-founder of Axial. Mazmanian has long focused on how the bacteria in our gut can be used to treat autism and Parkinson's dis- ease (PD.) Mazmanian noted that the company "wants to know what molecules the gut bacteria are making and the role they have in the gut-brain connection." Once we have accomplished this task, he continues, we can begin targeting these molecules in drug development. Through transplantation of the microbiota from human PD patients and healthy controls into germ-free mice, Mazmanian's research group established a causal relation- ship between the human microbiome and PD. After identifying the key differences between the PD and healthy microbiomes, Axial assumed the task of alter- ing molecules in the gut and manipulating microbial path- ways. Accomplishing this task, company officials reasoned, would alter the course of neurodegeneration. Affecting the microbes would, in turn, affect the brain. In recent work, Axial has focused on identifying certain metabolites found in high abundance in patients with ASD. Metabolomic analysis on serum samples obtained from the University of California, Davis, found that 33% of children with ASD have high dysregulation of the microbial derived metabolite 4-ethylphenyl sulfate (4-EPS), a small molecule caused by a breakdown of tyrosine by Clostridia bacteria. Although some level of 4-EPS is normally found in the body, the children with ASD had a much higher concentra- tion. And, when 4-EPS was injected into a mouse model of ASD, it induced anxiety-like behaviors. Because microbes make 4-EPS, modifications to reduce the amount of 4-EPS In recent work, Axial Biotherapeutics has focused on identifying certain metabolites found in high abundance in patients with autism spectrum disorder. Clostridium difficile causes nearly 500,000 infections in the United States each year. Finch Therapeu- tics is developing an orally ad- ministered investigational drug designed to break the cycle of infection by restoring the balance of the gut microbiome. (continued from previous page) Centers for Disease Control (CDC)

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