What happened
Shares of clinical-stage biotech Madrigal Pharmaceuticals (MDGL -0.81%) rose by as much as 18% in pre-market action Monday morning. The gains came in response to a positive top-line readout from a phase 3 clinical trial for resmetirom, its experimental fatty liver disease drug candidate.
Madrigal said that the drug was safe and well-tolerated at both the 80 mg and 100 mg dose levels assessed in the trial. Additionally, the company noted that patients with presumed non-alcoholic steatohepatitis (NASH) achieved significant reductions in liver fat and atherogenic lipids (macromolecules that often disrupt normal cell function) when treated with either dosage.
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Despite this encouraging clinical update, Madrigal's shares didn't hold onto most of these early gains. As of 12:08 p.m. ET, the biotech's shares were only up by 3.3%.
So what
Madrigal is presently running a pair of late-stage studies testing resmetirom as a treatment for NASH. Monday's data readout came from the MAESTRO-NAFLD-1 safety study. The next expected report of top-line results, from the all-important MAESTRO-NASH study, is expected sometime in the third quarter. The efficacy data from that trial will ultimately determine the drug's viability as a monotherapy for NASH.
Now what
Madrigal appears to be hoping that the initial efficacy data might be strong enough to warrant an accelerated regulatory filing for resmetirom in NASH. If that's the case, the biotech will have a shot at being the first to break into this massive and untapped drug market.
