In case you didn’t get the memo, Gilead is betting that a cocktail approach will win them a coveted place in the NASH showdown.
A day after drawing attention to positive proof-of-concept data around its cilofexor/firsocostat therapy, the Big Biotech says it’s kicking off another clinical trial in collaboration with Novo Nordisk in which semaglutide will be added to form a three-drug regimen.
A blockbuster favorite among up-and-coming diabetes drugs, semaglutide is a GLP-1 analogue that not only stimulates secretion of insulin but also is thought to improve glucose metabolism in the liver and increase fatty acid oxidation. Given that more than 40% of NASH patients have diabetes and more than 80% of them are also living with obesity (Novo Nordisk’s numbers) — another target indication for semaglutide — the Danish drugmaker has called its interest in the disease a “natural expansion.”
For Gilead, this will be an opportunity to fortify a growing NASH portfolio as well as flex its scientific muscles. The partnership also covers a potential collaboration on preclinical research to better understand an ailment often dubbed a silent disease.
With cardiopulmonary sales waning — caused by looming generic entry and illustrated by a round of layoffs announced this week — the hep C operations shrinking, HIV under assault and the bold new CAR-T venture slow to impress, Gilead is pressed to find a new area in which it can establish as formidable a presence as it had in the antiviral realm.
It took a hit when selonsertib flopped in a closely-watched Phase III, outperformed by the placebo at the low dose, dashing hopes for a vault to the lead position as a flock of small players take turns to present their own late-stage results.
As rivals — including Intercept, Genfit, Madrigal and NGM Bio, which is partnered with Merck — crowd in, Gilead has been picking up early-stage assets in pursuit of a sustaining franchise. In fact, cilofexor came from the buyout of Phenex Pharma and you might remember firsocostat as GS-0976, which Gilead paid Nimbus $600 million for.
The company also hasn’t given up on selonsertib, which is being tested in a triple combo with cilofexor and firsocostat.
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