Summit Clinical Research, PathAI partner on clinical trial services for NASH treatments

Summit Clinical Research is partnering with Big Pharma-backed artificial intelligence startup PathAI to help drug developers work on clinical trials for treatments under development for a chronic liver disease. 

The clinical research organization has already supported dozens of nonalcoholic steatohepatitis, or NASH, trials and is partnering with PathAI to reduce barriers to making drugs for the disease. These hurdles entail site activation costs, patient enrollment, slow diagnostics and inaccuracies in studying NASH, the companies said Wednesday.

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The partnership revolves around PathAI's NASH drug development tool, which is being evaluated by the FDA and the European Medicines Agency for biomarker qualification programs. The platform is meant to assess enrollment criteria, primary endpoints and measure the response to treatment, said Summit President Stephen Harrison, M.D., in a statement. 

PathAI's acquisition of pathology lab company Poplar Healthcare in July and a network of expert liver pathologists will also contribute to the partnership. The two companies have contracted with a sponsor on a phase 2 clinical trial, and the pair is working on securing contracts for "several additional trials."

Backed by the likes of Bristol Myers Squibb, Merck and Labcorp, PathAI uses machine learning to identify disease biomarkers and help predict how patients will respond to treatments on an individual level. 

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PathAI's experience in NASH drug development includes partnering with Gilead Sciences on machine learning to take pathologists' subjective measures out of liver biopsies. The Big Pharma is working with Novo Nordisk on a NASH cocktail. 

For its part, Summit's expertise in NASH spans 40 sponsors and 60 projects across 90 sites. The company's sites are located in the U.S., France, Germany, Argentina, Italy and Mexico.

The company is listed as a study location for Sagimet Biosciences' phase 2b study of an oral, once-daily pill in patients with NASH. The drug, TVB-2640, showed statistically significant improvements across multiple biomarkers in a phase 2a trial, Sagimet said in its IPO prospectus in April.

Summit is also a study location for NASH treatments being evaluated by biopharmas including Intercept Pharmaceuticals and Pfizer, which is testing a failed drug's follow-on candidate.