Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) is engaged as a clinical-stage biopharmaceutical company, which is focused on the research and development of innovative therapies to treat nonalcoholic steatohepatitis (NASH), a liver disease with a significant unmet medical need. Shares of the biopharma company are skyrocketing 251% through late trading on Monday, December 19, 2022. Over the past three months, Madrigal Pharmaceuticals has seen average daily volume of 313,890 shares. However, volume of 7.17 million shares or dollar volume of around $1.56 billion, has already exchanged hands through late trading.
Shares of Madrigal Pharmaceuticals are surging after the company released positive topline results from its Phase 3 MAESTRO-NASH clinical trial of Resmetirom for the treatment of NASH and liver fibrosis. During the Phase 3 trial, the company conducted a 52-week serial liver biopsy study in over 950 patients. Resmetirom was found to achieve both primary and secondary endpoints with both its daily oral doses of 80 mg and 100 mg, relative to the placebo group.
The MAESTRO-NASH Phase 3 trial will continue to provide enrolled patients with therapy after the 52nd week of the clinical trial, for a total of 54 months to accrue hepatic clinical outcome events including histologic conversion to cirrhosis and hepatic decompensation events. At the beginning of the trial, baseline liver biopsy fibrosis scores were not good, with 84% NAS > 5 based on independent primary glass slide reads.
After 52 weeks of treatment, a second biopsy was conducted to assess efficacy of the treatment. The results showed a statistically significant response at both the 80 mg and 100 mg doses. Secondary liver biopsy endpoints were met at both doses after a >2 point reduction in NAS with no worsening fibrosis, >2 point reduction in NAS with ?1-stage improvement in fibrosis, NASH resolution (>2 point reduction in NAS) with >1-stage improvement in fibrosis, and a 2-stage reduction in fibrosis without worsening of NAS. Resmetirom was safe and well-tolerated throughout the study, similar to the results from the previous Phase 2 & 3 data.
Becky Taub, M.D., Chief Medical Officer and President of Research & Development of Madrigal: “These pivotal Phase 3 results demonstrate the potential for resmetirom to help patients achieve improvement in both the underlying steatohepatitis that drives this disease and the resulting fibrosis that is associated with progression to cirrhosis and its complications. The topline data also reinforce our confidence in the safety and tolerability profile of resmetirom. 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 (NDA) and the potential accelerated approval of resmetirom for the treatment of non-cirrhotic NASH with liver fibrosis.”
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