FDA Accepts Liver Stiffness Measurement โas Surrogate Endpoint,Accelerating MASH Drug Development
Washington D.C. – In a landmark decisionโ poised to โฃdramatically accelerate the development of โฃtreatments for metabolic-associatedโ steatohepatitisโ (MASH), โformerly known as NASH, the Food and Drug โขAdministration โ(FDA) has acceptedโข liver stiffness measurementโ (LSM) by Vibration Controlled Transient Elastography (VCTE) as a surrogate endpointโข for clinical benefit. This change, announced recently,โข streamlines the pathway for drug approvals in MASH, a condition affecting millions wiht no currently approved pharmaceutical therapies.
Previously, MASH drugโค trials โrequired lengthy and โขcostly โฃstudies โฃtracking histologicalโค improvements – examining liverโ tissue biopsiesโ – to demonstrate efficacy. The FDA’sโ acceptance of LSM by VCTE, a non-invasive method of assessingโ liverโข fibrosis, significantly reduces the time โฃand resources needed for clinical trials, potentially bringing effective treatments to patients faster. This decisionโ impacts pharmaceutical companies currently โขdeveloping MASH therapies, and also the estimated 1.5โ million Americans and millions more worldwide affected โby the disease.The acceptance of LSM by VCTE builds on growing evidence demonstrating its correlation with โฃlong-term clinical outcomes, includingโ liver-related eventsโฃ andโข mortality. Severalโค key trialsโฃ are already utilizing โthe โขendpoint, including โฃMadrigal Pharmaceuticals’ SYNCHRONY-Outcomes trial ofโข efruxifermin and 89bio’s โฃENLIGHTEN-Cirrhosis trial of pegozafermin. Additionally,โ LSM by VCTE is โขbeing โemployed in alcohol-related liver disease (ALD) trials, such as GSK’s Phase II STARLIGHT trial of GSK4532990 and Altimmune’s Phase II RESTORE trial of pemvidutide. โ
According to Jay Patel, a Pharma analyst with GlobalData, the FDA’s decision โฃ”consolidates Echosens’ positionโ as the leading non-invasiveโ diagnostic manufacturer โinโ the MASH โขspaceโค and openedโ the โdoorโค for faster approval of a wider โคrangeโ of drugs to meet the unmetโ need in this growing disease.”โ Echosensโ recently launched its Guided VCTE technology, furtherโค streamlining โคthe assessment process.
Theโฃ shift is expected to โencourage increased โฃinvestment โand โinnovation in MASH โขdrug development, offering hope for patientsโข facing a condition that can progress to โคcirrhosis, liver failure, โandโ the need for transplantation.