In a year that has seen an approval and a raft of readouts for metabolic dysfunction-associated steatohepatitis (MASH), Gilead has decided to walk away from a $785 million biobucks deal in the tricky liver disease.
The U.S. drugmaker has “mutually agreed” to terminate its collaboration and license agreement with South Korean biotech Yuhan for a pair of MASH therapies. It means Gilead has lost the $15 million upfront payment it made to sign the deal back in 2019, although it will also avoid paying out any of the $770 million in milestones tied to the agreement.
The two companies have worked together on preclinical studies of the drugs, a Gilead spokesperson told Fierce Biotech.
“One of these candidates demonstrated strong anti-inflammatory and anti-fibrotic efficacy in the preclinical setting, reaching the final candidate selection stage for decision for further development,” the spokesperson added.
Clearly, the preclinical data wasn’t ultimately enough to persuade Gilead to stick around, leaving Yuhan to explore the drugs’ potential in other indications.
MASH is a notoriously tricky indication, and this isn’t the first of Gilead’s bets in the space not to have paid off. The company’s MASH hopeful selonsertib flamed out in a pair of phase 3 failures back in 2019.
The only MASH program still listed in Gilead’s clinical pipeline is a combination of Novo Nordisk’s semaglutide with cilofexor and firsocostat—MASH prospects that Gilead licensed from Phenex Pharmaceuticals and Nimbus Therapeutics, respectively.
Still, Gilead doesn’t appear to have lost interest in the liver completely, paying $4.3 billion earlier this year to acquire CymaBay Therapeutics specifically for its primary biliary cholangitis med seladelpar. The biotech had previously been pursuing seladelpar in MASH until a failed trial in 2019.
The MASH space changed for good this year when Madrigal Pharmaceuticals became the first company to get a drug approved by the FDA to treat the condition in the form of Rezdiffra. This year has also seen a number of data drops from potential MASH prospects, including Viking Therapeutics, which is hoping that its own contender VK2809 could give Madrigal a run for its money.