After High-Profile NASH Failure, Gilead Resets with Renown IHI to Sequence Patient DNA
Gilead Sciences, headquartered in Foster City, California, and the Renown Institute for Health Innovation (IHI), located in Reno, Nevada, have teamed up to study nonalcoholic steatohepatitis (NASH).
Under the terms of the collaboration and license deal, Gilead will fund Renown IHI’s efforts to sequence and analyze the DNA of 15,000 people who have been diagnosed with NASH or nonalcoholic fatty liver disease (NAFLD) in addition to a control group of 40,000 people in Nevada. NASH is a disease similar to cirrhosis of the liver, but which occurs in people who drink little or no alcohol. It is related to the epidemic of obesity and diabetes.
“Combining the sequencing of protein-coding DNA, with extensive electronic health record data will enable a deep analysis of the roles of genetics and environment in NASH incidence and progression,” stated John McHutchison, chief scientific officer and head of Research and Development at Gilead. “The analysis of these large datasets in collaboration with Renown IHI could help identify genetic variants that impact the risk of developing NASH and thereby advance the discovery and development of new treatments for this disease.”
Gilead, which has a deep interest and expertise in diseases of the liver, has a significant investment in developing drugs for NASH. It has selonsertib, firsocostat, and cilfexor in various combinations to treat NASH in several clinical trials. In April, the company announced a collaboration with Novo Nordisk to development combination regimens for NASH, with plans to launch a proof-of-concept trial for the combination of Gilead’s cilofexor and firsocostat with Novo Nordisk’s semaglutide. It also announced in April a three-year collaboration with insitro to use the company’s technology platform for the discovery of novel drug targets related to NASH.
That said, in April, Gilead’s STELLAR-3 Phase III clinical trial of selonsertib in NASH failed to meet its primary endpoint. At the time, Hutchison said, “We are actively exploring the STELLAR data and will work with external collaborators like PathAI and insitro, to further our understanding of this complex disease and advance our development programs.”
Renown IHI is an integrated healthcare network that handles electronic records for 1.02 million registered patients. It has created several ongoing projects to collect and analyze patient health and genetic date. These include a 2016 collaboration with the Desert Research Institute to found the Healthy Nevada Project (HNP). In 2017, HNP launched a partnership with Helix to use its population health services, Exome+ sequencing and consumer engagement tools. This is now an ongoing partnership with Renown IHI, the Desert Research Institute, and Helix, which is a personal genomics company. HNP currently has 40,000 participants.
“Combining genetic sequencing with large sets of data can play a critical role in understanding and identifying serious health risks, including diseases like NASH,” stated Anthony Slonim, president and chief executive officer of Renown Health. “We are excited to collaborate with Gilead to better understand the condition and its complexities. Any genetic variants identified in participants through the collaboration may be shared with the participants for patient care purposes.”