Less than one year after it was launched, South San Francisco-based insitro has inked a three-year collaboration with Gilead Sciences to discover and develop therapies for patients with nonalcoholic steatohepatitis (NASH).
NASH is one of the primary indications at which Gilead is aiming its R&D pipeline. Last week, the Foster City, Calif. company joined forces with Novo Nordisk to combine medications within their pipelines for treatment of NASH. Gilead also has its own programs aimed at the liver disease that has become a growing health concern with the increase in levels of obesity across the United States and other parts of the world. Last week, Gilead presented new proof of concept data that showed positive data from a combination treatment of cilofexor and firsocostat resulted in improvements in hepatic steatosis, liver stiffness, liver biochemistry and serum fibrosis markers.
With insitro, Gilead will use that company’s proprietary insitro Human (ISH) platform to create disease models for NASH and discover targets that have an influence on clinical progression and regression of the disease. The ISH platform applies machine learning, human genetics and functional genomics to generate and optimize unique in vitro models in order to drive the discovery and development of new treatments. Under terms of the deal, Gilead can advance up to five targets identified through this collaboration and will be responsible for chemistry and development against these targets.
As Gilead pushes ahead in NASH, the company is casting a wider net with partnerships in order to help it overcome a setback with its late-stage NASH candidate selonsertib, which failed to hit its primary endpoint in a Phase III trial.
Gilead will provide insitro with $15 million in upfront cash, as well as additional near-term payments of up to $35 million based on milestones. insitro is also eligible for up to $200 million per each of the targets that Gilead aims for. Under terms of the deal, insitro can opt-in on the targets Gilead has selected and will have the rights to co-develop in the United States.
John McHutchison, Gilead’s chief scientific officer and head of R&D, reiterated the company’s commitment to developing treatments for NASH, particularly those with advanced fibrosis who have the greatest unmet need.
“We are excited about the opportunity to partner with insitro to tackle the scientific challenges associated with this complex disease. Through this collaboration we will utilize deep learning to explore the scientific underpinnings of the biology and clinical spectrum of NASH, with the goal of accelerating the development of highly effective treatment options for patients with this disease,” McHutchison said in a statement.
Stanford professor and Coursera founder Daphne Koller, who founded and helms insitro, said NASH will be the primary cause for liver transplants in the U.S. Koller said she and her team are excited to work with Gilead to identify new therapeutics for NASH and help patients across the globe.
NASH is estimated to affect more than 16 million people in the U.S. alone. If untreated, NASH patients face serious consequences, including end-stage liver disease, liver cancer and the need for liver transplantation Also, they are at a significantly higher risk of liver-related mortality. Current treatment standards for NASH are lifestyle changes, including diet, weight loss and exercise. Because of the lack of approved treatments for NASH, it has become a wildly popular target for companies. There are nearly 200 experimental treatments in the pipeline of drugmakers. With the plethora of companies aiming resources at NASH and the increasing growth of the disease, GlobalData has speculated the NASH market will hit $18.3 billion by 2026.
In addition to its deal with Gilead, insitro also secured $100 million in a Series A funding round led by Arch Venture Partners, Foresite Capital, GV and Third Rock Ventures.
A Product Manager with expertise in pharma marketing and sales operations