We recently caught up with the management team at Madrigal Pharmaceuticals (MDGL) to provide an update as the all-important Phase III MAESTRO NASH trial, suggests John McCamant, editor of The Medical Technology Stock Letter.
This trial is poised to read out this quarter (potentially as soon as this month). In our view, the Phase III MAESTRO NASH (Nonalcoholic steatohepatitis) trial will read out positive based on the totality of the positive Phase II and Phase III MAESTRO NAFLD trials.
One interesting development is that ICER — the Institute for Clinical and Economic Review — is undergoing a review of resmetirom that should be completed mid-2023
ICER’s goal is to improve access and affordability while retaining the incentives necessary for future innovation. In our view, resmetirom has a very good chance to get an excellent ICER review as an oral small molecule will be relatively low priced, maybe $5-7 K per year.
We also believe that resmitirom has the potential to prevent NASH progression which the recently started Outcomes trial will show. A low-priced drug that adds quality years of life is exactly the kind of drug that receives a great ICER rating.
In our view, the Phase III MAESTRO NASH trial will read out positive based on the totality of the positive Phase II and Phase III MAESTRO NAFLD trials. As a reminder, the dual primary surrogate endpoints on biopsy are NASH resolution with ≥2-point reduction in NAS (NAFLD Activity Score), and with no worsening of fibrosis OR a 1-point decrease in fibrosis with no worsening of NASH.
Achievement of either primary endpoint is considered a successful trial outcome. A key secondary endpoint is lowering of LDL-C. In our view, the Phase III MAESTRO NASH trial will read out positive based on the totality of the positive Phase II and Phase III MAESTRO NAFLD trials.
The ICER review is a new catalyst and will come at a strategic time (mid-2023) as the company should be in the process of filing resmetirom for FDA approval. MDGL is a buy under $200 with a price target of $275.
