Gilead Sciences has tapped FierceMedTech Fierce 15 winner Glympse Bio to help develop a non-invasive diagnostic test for nonalcoholic steatohepatitis, also known as the fatty liver disease NASH.
Glympse employs a set of synthetic, in vivo biomarkers made of compounds engineered to react to the presence of specific diseases within the body. Those reactions produce chemical signals that are collected and analyzed after the injection passes through the patient’s system.
The Cambridge, Massachusetts-based company hopes that its artificial biomarkers will outperform the body’s natural ones and NASH is its primary target. The chronic, asymptomatic and heterogeneous disease can be very hard to diagnose—either non-invasively or through tissue biopsies—and its set to become the leading cause of liver transplantations in the U.S.
Through its public debut and $22 million series A round last year, Glympse said it had signed on for NASH collaborations with multiple pharmaceutical companies, to help screen for disease and monitor clinical responses.
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NASH has become a priority for Gilead as well, taking a place alongside its past work in other liver maladies such as hepatitis B and C. The Big Pharma inked a $785 million NASH research deal at the top of this year with the South Korean biotech Yuhan to add two preclinical compounds to its pipeline. Gilead also has tie-ups with Nimbus and Scholar Rock—as well as a deal with Daphne Koller’s Insitro that could surpass $1 billion—in addition to the company’s internal programs.
However, Gilead hit setbacks in both February and April of this year, with its prospective NASH drug selonsertib failing two phase 3 trials. The ASK1 inhibitor did worse than placebo in reducing liver scarring and fibrosis among hundreds of patients.
Going forward, Gilead hopes it will find an effective therapy in a combination treatment approach—mixing selonsertib with the FXR agonist cilofexor and ACC inhibitor firsocostat, for example. The latter two taken together showed improvements in liver stiffness and serum scarring biomarkers in a small, proof-of-concept study presented earlier this year at the International Liver Congress kicks off in Vienna, Austria. A phase 2 study of the trio is expected to report data this year.
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That’s where Glympse comes in. Gilead plans to use its biomarkers to identify the stages and progression of NASH, as well as to help detect early signs of patients’ responses to treatment.
“By utilizing this innovative technology, we hope to better characterize this complex disease and improve our understanding of how our compounds impact disease progression,” said Gilead’s senior vice president of liver diseases, Mani Subramanian.
The tests will be used to in the initial screenings of clinical trial participants, as well as throughout studies in the company’s NASH development program. The financial terms of the collaboration were not disclosed.