On Wednesday, Madrigal Prescription drugs, Inc. MDGL reported two-year outcomes from the open-label compensated MASH cirrhosis (F4c) arm of the Part 3 MAESTRO-NAFLD-1 trial of Rezdiffra (resmetirom).
Sufferers handled with Rezdiffra achieved marked reductions in liver stiffness, a surrogate for fibrosis, measured by vibration-controlled transient elastography (VCTE).
The Part 3 MAESTRO-NAFLD-1 trial of Rezdiffra included an open-label energetic therapy arm of sufferers with compensated MASH cirrhosis. Madrigal beforehand reported one-year outcomes from this cohort.
Following two years of therapy, 101 sufferers had VCTE outcomes for evaluation.
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The imply liver stiffness at baseline was 25 kPa. Sufferers achieved a imply 6.7 kPa discount in liver stiffness at two years (6.1 kPa at one yr), which was statistically vital in comparison with baseline.
In a responder evaluation analyzing ≥25% enchancment or worsening of liver stiffness, 51% of sufferers achieved enchancment. The corporate says enchancment of this magnitude has been related to decreased development to end-stage liver illness.
Draft FDA steering recommends that Part 3 medical trials in MASH cirrhosis use outcomes as an endpoint as an alternative of biopsy-based surrogate endpoints.
Rezdiffra is indicated at the side of food plan and train for the therapy of adults with noncirrhotic MASH with reasonable to superior liver fibrosis (according to levels F2 to F3 fibrosis).
Continued approval for this indication could also be contingent upon verification and outline of medical profit in ongoing confirmatory trials.
Rezdiffra is just not authorized for the therapy of sufferers with MASH cirrhosis.
Concurrently, Madrigal Prescription drugs reported a fourth-quarter lack of $2.71 per share, down from a lack of $5.68 a yr in the past, beating the consensus lack of $4.16 per share.
The corporate reported gross sales of $103.22 million, beating the consensus of $98.56 million.
Invoice Sibold, Chief Govt Officer of Madrigal, said, “Wanting again on 2024, I am extremely pleased with what we completed. We secured FDA approval for Rezdiffra, the primary drugs authorized for MASH, in March; executed a first-in-disease launch with outstanding outcomes; and are effectively positioned for robust efficiency once more in 2025 and past.”
Value Motion: MDGL inventory is up 20.30% at $372.26 on the final verify on Wednesday.
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