Gilead doubles down on NASH with two deals in one week

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Gilead arranges partnerships with insitro and Novo Nordisk to develop new options for patients with NASH.

The partnership with insitro was announced today, with Gilead paying $15m (€13.2m) upfront and promising a further $35m in ‘near-term payments’ based on operational milestones.

An additional $1bn could be earned by insitro based on five potential drug candidates that could be developed through the partnership, dependent upon their success at various developmental and commercial stages.

The drug candidates will target nonalcoholic steatohepatitis (NASH) disease, an area that forms a core part of Gilead’s current treatment portfolio.

Gilead is looking to use insitro’s drug discovery platform, which utilises machine learning, human genetics, and functional genomics, to develop new treatment modalities for the disease area.

John McHutchison, CSO of Gilead Sciences, said, “Through this collaboration, we will utilise 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.”

The partnership will run for an initial three-year period.

Understanding the science behind NASH

Only five days prior, Gilead announced that it would partner with Novo Nordisk in the clinic to develop a potential combination therapy for NASH.

This will see Gilead contribute cilofexor, a FXR agonist, and firsocostat, an ACC inhibitor, while Novo will add semaglutide, a GLP-1 analogue, to provide a potential triple therapy for the condition.

Novo’s semaglutide increases the production of insulin in patients and McHutchison noted in a statement that NASH often affects people with diabetes and metabolic syndrome.

Gilead does not yet have approval for the combination treatment, but both companies are looking to the addition of the GLP-1 as a ‘complementary’ research approach.

On the same day as the partnership announcement, Gilead stated that the combination of cilofexor and firsocostat resulted in the decline of at least 30% of hepatic fat in 74% of patients treated, in a Phase II study.

The companies also announced that, similar to Gilead’s deal with insitro, they will cooperate to advance an understanding of the disease, by undertaking preclinical research.

For Gilead, both partnerships represent an opportunity to expand its portfolio in liver disease, where it currently holds seven approved products and a further five clinical candidates.