FDA acceptance of VCTE as trial endpoint can accelerate MASH drug development: GlobalData

Following the news that the US FDA has accepted Echosens’ letter of intent to qualify liver stiffness measurement (LSM) by vibration-controlled transient elastography (VCTE) as a reasonably likely surrogate endpoint for metabolic dysfunction-associated steatohepatitis (MASH) trials with moderate-to-advanced fibrosis;

Jay Patel, Senior Pharma Analyst at GlobalData, a leading data and analytics company, comments,“The announcement can have a transformational impact on future MASH clinical trials, driving a shift away from the use of liver biopsies in diagnosis and assessment of disease progression.

“Biopsies are known to be highly invasive, causing discomfort and safety concerns for patients. This in turn complicates trial enrolment, driving up costs and causing unnecessary delays, creating a demand for non-invasive alternatives. This acceptance could therefore pave the way for faster clinical trial recruitment, potentially delivering early drug approvals.

“This will no doubt strengthen the competitive position of Echosens, the developer of the FibroScan diagnostic system that measures LSM by VCTE. Given that it now boasts the sole NIT with surrogate endpoint status, drug developers will likely be eager to adopt its technology to get their assets on the market faster. Echosens can also grow its impressive array of existing partners, which currently include Boehringer Ingelheim, Novo Nordisk and Inventiva.

“The recent announcement by Eli Lilly that it would pursue a Phase III trial of tirzepatide and retratrutide in metabolic dysfunction-associated steatotic liver disease (MASLD) with non-invasive recruitment is evidence that major companies in the metabolic disease market are dedicated to embracing this shift. While it remains to be seen whether Lilly will adopt LSM by VCTE, the FDA’s announcement aligns perfectly with the company’s plans and could offer its assets a pathway to accelerated approval.”