‘Convincing Results’
Commenting on the study, co-moderator Sven Francque, MD, hepatologist and head of department at the University Hospital of Antwerp, Belgium, said that the study was in a relatively “severe” patient population, which was one of its strengths.
“These are convincing results in terms of MASH resolution, showing a strong response and dose-dependence,” he said.
Dr. Francque
Dr. Sven Francque
“In terms of fibrosis, the results look numerically strong but are somewhat more puzzling to interpret, as there was no dose-response relationship and no data on NITs [noninvasive tests] that could support the results,” he added.
“Patients with no-end-of-treatment biopsies were handled differently than in previous trials, which makes it difficult to appreciate antifibrotic potency,” he said. But “such a strong effect on MASH should translate into a reduction in fibrosis even in the absence of direct antifibrotic effects.”
Given that “about one third of patients in the active treatment arms” did not have end-of-treatment biopsy, these “are rather small numbers precluding firm conclusions,” he added.
However, Dr. Francque said that he believes the findings are compelling enough for the drug to go into phase 3 trials.
Dr. Francque has no disclosures of relevance to this study. Dr. Loomba serves as a consultant to Aardvark Therapeutics, Altimmune, Anylam/Regeneron, Amgen, Arrowhead Pharmaceuticals, AstraZeneca, Bristol Myers Squibb, CohBar, Eli Lilly, Galmed, Gilead, Glympse Bio, Hightide, Inipharma, Intercept, Inventiva, Ionis, Janssen, Madrigal, Metacrine, NGM Biopharmaceuticals, Novartis, Novo Nordisk, Merck, Pfizer, Sagimet, Theratechnologies, 89 bio, Terns Pharmaceuticals and Viking Therapeutics. In addition, his institutions received research grants from Arrowhead Pharmaceuticals, AstraZeneca, Boehringer-Ingelheim, Bristol Myers Squibb, Eli Lilly, Galectin Therapeutics, Galmed Pharmaceuticals, Gilead, Intercept, Hanmi, Intercept, Inventiva, Ionis, Janssen, Madrigal Pharmaceuticals, Merck, NGM Biopharmaceuticals, Novo Nordisk, Merck, Pfizer, Sonic Incytes, and Terns Pharmaceuticals. Dr. Loomba is a co-founder of LipoNexus.
A version of this article first appeared on Medscape.com.
