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Gilead drives NASH development with insitro collaboration

Announcement comes days after Novo Nordisk deal


Gilead is further extending its work in non-alcoholic steatohepatitis (NASH), teaming up with San Francisco-based drug discovery group insitro for a three-year R&D deal.

The move comes not long after the drugmaker released some disappointing late-stage results for its NASH candidate selonsertib, which failed to meet its main goal of improving fibrosis without worsening of NASH.

That data came as a setback for Gilead, which, like many other drugmakers, is competing for the first-to-market status in NASH.

The chances of that being a Gilead candidate is overshadowed by Intercept’s recent FDA filing of its own NASH candidate Ocaliva, although that drug is making investors nervous with its mixed efficacy results.

Nevertheless, Gilead is hoping the new deal will help revive its fortunes, with the company offering insitro an upfront payment of $15m to create NASH-based disease models and help discover targets that have an influence on clinical progression and regression of the disease.

To do this, insitro will utilise its Human (ISH) platform, which applies machine learning, human genetics and functional genomics to generate in vitro models and drive therapeutic discovery and development.

The deal with Gilead marks insitro’s first pharmaceutical based partnership, and what’s particularly appealing to Gilead is the tech’s ability to suggest candidate targets and predict patient response to potential therapeutic interventions.

“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,” said John McHutchison, Chief Scientific Officer and Head of Research and Development, Gilead Sciences.

“We are excited about the opportunity to partner with insitro to tackle the scientific challenges associated with this complex disease.”

As per 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.

Insitro could also receive up to $200 million for the achievement of preclinical, development, regulatory and commercial milestones for each of those targets; and up to low double-digit tiered royalties on net sales.

“NASH is a progressive liver disease that can lead to fibrosis, cirrhosis, and liver cancer and will soon be the predominant cause of liver transplantation in the US,” said Daphne Koller, CEO and founder of insitro.

“We are excited to work with Gilead, a leader in liver disease, in bringing to bear novel tools toward identifying new therapeutics for NASH and helping the many patients in need around the world.”

For Gilead, the partnership marks the second deal in NASH it has made this year; the first being with Novo Nordisk to develop a three-drug cocktail.

That deal will see the companies combine Novo’s diabetes blockbuster semaglutide with Gilead’s cilofexor and firsocostat in a proof-of-concept study.

“Gilead is committed to researching and developing treatments for patients living with NASH, particularly those with advanced fibrosis who have the greatest unmet need,” concludes McHutchison.

Article by
Gemma Jones

16th April 2019

From: Research



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