Madrigal Pharmaceuticals Breaks Through In NASH With Late-Stage Win

NASH concept

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Monday, Madrigal Pharmaceuticals announced that resmetirom hit both primary endpoints and a key secondary endpoint in the Phase III MAESTRO-NASH biopsy trial. As a result, the clinical-stage drugmaker’s shares jumped by 209% in pre-market trading Monday. 

The MAESTRO-NASH trial evaluated an 80 mg and a 100 mg dosage of the thyroid hormone receptor agonist resmetirom, against a placebo, in patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH). NASH is an advanced form of fatty liver disease. 

Across both dosing levels, resmetirom-treated patients exhibited significantly higher levels of NASH resolution and liver fibrosis improvement (the study’s co-primary endpoints) in the late-stage trial compared to individuals in the placebo group.  

Treatment with the orally-administered drug also significantly improved LDL-C cholesterol levels (“bad cholesterol”), a key secondary endpoint in the study.

Madrigal’s management noted in the press release that resmetirom was safe and well-tolerated at both dosing levels among study participants. 

Madrigal’s leadership intends to file for resmetirom’s approval, on an accelerated basis, with the FDA as a treatment for non-cirrhotic NASH with liver fibrosis in the first half of 2023.

The drug would become the first NASH medication on the market if approved. 

What’s next?

With this late-stage success, Madrigal is a top buyout candidate heading into 2023. NASH is one of the hottest research areas in all of biopharma, with more than 300 active clinical trials underway. 

What’s more, NASH is one of the toughest conditions to successfully drug. In recent years, for instance, Gilead Sciences, Novo Nordisk, Intercept Pharmaceuticals, among others, have all posted disappointing NASH trial results. 

Madrigal’s resmetirom is a unicorn and will likely be the subject of a bidding war in early 2023. 

On that note, Viking Therapeutics may also be a top buyout candidate behind these strong Phase III trial results. Viking’s NASH offering, known as VK2809, belongs to the same class of medications as resmetirom. 

VK2809 is currently being evaluated in a Phase IIb study in biopsy-confirmed NASH patients.

Topline data are due sometime in the second quarter of 2023, as Viking’s President and CEO Brian Lian told BioSpace in an interview.

What's more, Viking's market cap is substantially lower than Madrigal’s. Viking may prove to be a less expensive option for would-be acquirers. 

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