The clinical-stage biopharmaceutical firm Madrigal Pharmaceuticals Inc. (Nasdaq: MDGL) has increased 211.13% to $198.50 in pre-market trading on the most recent Monday after announcing topline clinical trial results.
What outcomes has MDGL announced?
Resmetirom, a liver-directed specific thyroid hormone receptor agonist, was tested in the key Phase 3 MAESTRO-NASH biopsy research study by Madrigal Pharmaceuticals (MDGL). Both of the liver histological improvement objectives that the FDA recommended as fairly expected to predict clinical benefit to justify expedited approval for the treatment of NASH with liver fibrosis were met in MAESTRO-NASH, a formal methods Phase 3 study of Madrigal Pharmaceuticals.
These critical Phase 3 findings from MDGL show the possibility of resmetirom to assist patients in improving both the fibrosis that develops as the illness progresses to cirrhosis and its consequences as well as the inherent steatohepatitis that fuels it. The topline statistics also increase MDGL’s trust in the resmetirom’s safety and tolerability profile.
MDGL has a solid foundation for its new drug application (NDA) and the likely accelerated authorization of resmetirom for the detection of non-NASH with liver fibrosis thanks to the Phase 3 MAESTRO clinical development program, which includes the MAESTRO-NAFLD-OLE and MAESTRO-NAFLD-1 and safety clinical trials as well as the recently started MAESTRO-NASH-OUTCOMES clinical trial.
With no authorized therapy, NASH with liver diseases puts patients in danger of developing organ failure, liver cancer, needing a liver transplant, and early mortality. This condition represents one of the most critical unmet needs in modern healthcare. These ground-breaking findings from the MAESTRO-NASH research study represent a significant shift in the field.
With the help of a second Phase 3 clinical study, MAESTRO-NAFLD-OLE, and MAESTRO-NASH, we have developed a sizable safety database to assist benefit-risk analysis. MAESTRO-NASH also met both primary objectives that the FDA had suggested as fairly capable of predicting clinical benefit.
In order to accrue hepatic clinical outcome events, such as histologic transformation to cirrhosis and hepatic ultimately reduced events, enrolled patients must continue receiving rehab after the Week 52 clinical examination for up to a total of 54 months. This study, MAESTRO-NASH, is a recurring blinded Phase 3 clinical trial.
What other plans does MDGL have?
With these categorically favorable Phase 3 results in hand, MDGL’s future course is obvious. Madrigal Pharmaceuticals (MDGL) plans to submit a new medication application in the first half of 2023 asking for resmetirom’s expedited approval.