Madrigal Pharmaceuticals Inc (NASDAQ:MDGL) shares have soared more than 250% after the biopharmaceutical company shared positive topline results from its pivotal Phase 3 MAESTRO-NASH biopsy clinical trial of resmetirom, a liver-directed selective thyroid hormone receptor agonist.
The company, which is pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), said that resmetirom achieved both primary endpoints and potentially clinically meaningful effects with both daily oral doses 80mg and 100mg relative to placebo in the 52-week serial biopsy trial of more than 950 patients.
Resmetirom was safe and well-tolerated in the MAESTRO-NASH study, consistent with the overall safety in Phase 3 MAESTRO trials and expanding the large safety database, Madrigal added.
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The company said it intends to file a new drug application seeking accelerated approval of resmetirom for the treatment of non-cirrhotic NASH with liver fibrosis.
Madrigal chief medical officer Rebecca Taub said these Phase 3 results demonstrated the potential for resmetirom to help patients achieve improvement in both the underlying steatohepatitis that drives NASH and the resulting fibrosis that is associated with progression to cirrhosis and its complications.
“We believe the Phase 3 MAESTRO clinical development program, including the MAESTRO-NAFLD-1 and MAESTRO-NAFLD-OLE safety clinical trials and the recently initiated MAESTRO-NASH-OUTCOMES clinical trial, provides a strong foundation for our new drug application and the potential accelerated approval of resmetirom for the treatment of non-cirrhotic NASH with liver fibrosis,” Taub said.
Madrigal stock was up about 255% at US$226.50 per share on Monday morning.
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