ADA: NGM backs up case for once-monthly dosing of Merck-partnered NASH drug

Diabetes tools
NGM Biopharmaceuticals and Merck are behind nonalcoholic steatohepatitis rivals targeting the diabetes market but are hoping to pull ahead with the promise of convenient dosing. (Getty/relif)

NGM Biopharmaceuticals and partner Merck have generated a lot of excitement over their early-stage treatment for nonalcoholic steatohepatitis (NASH) and Type 2 diabetes, MK-3655, even though they’re well behind several rivals who are working on similar drugs. Now, they have new data from a phase 1b trial to back up what they hope will be their major selling point: a more convenient dosing schedule.

At the Scientific Sessions of the American Diabetes Association (ADA) in San Francisco, NGM released data comparing insulin sensitivity in patients given either a single dose of MK-3655 or daily doses of Actos (pioglitazone) over 36 days. Insulin sensitivity was measured at days one and 29. The single dose of MK-3655 produced a significant improvement in whole-body insulin sensitivity that was comparable to daily dosing of Actos, the company said.

RELATED: NGM Bio nabs $107M IPO after new Merck deal, poaches Roche exec

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MK-3655 is designed to activate the β-Klotho/FGFR1c receptor complex. Merck intends to move it into a phase 2b study for NASH patients either with diabetes or without it. But it’s behind companies like Intercept Pharmaceuticals, which rolled out positive phase 3 data for its once-per-day NASH drug, obeticholic acid, in February and is now preparing to file for FDA approval.

Merck believes that the potential of NGM’s drug to be dosed monthly could allow it to surpass any rivals that may hit the market first. As an agonist of the β-Klotho/FGFR1c receptor complex, MK-3655 is specifically designed to be dosed infrequently.

Merck teamed up with NGM in 2015 to take the asset through early-stage trials, and in January of this year, it scooped up exclusive global rights to the drug. That deal, which came with a $20 million upfront payment to NGM, gives the biotech an option to split the costs and profits once the drug moves into phase 3 trials.

NGM had already released data from the phase 1b trial of MK-3655 showing improvements in the reduction of liver fat and other metabolic markers, including lower levels of triglycerides and LDL. And in April, the company pulled in $107 million in an IPO—$32 million more than it had hoped to raise. Much of that will be poured into its lead NASH asset, NGM282.

Whether infrequent dosing helps NGM and Merck stand out in the crowded diabetes market with MK-3655 is an open question. Several companies are testing NASH drugs in diabetes patients, including GenFit, which also had a blowout IPO this year. And at ADA, Eli Lilly announced that it will expand clinical trials of its long-acting diabetes drug tirzepatide to include NASH patients.

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