LianBio LIAN announced topline results from the Phase 3 EXPLORER-CN trial investigating mavacamten for Chinese patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
The 81-subject study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in Valsalva left ventricular outflow tract (LVOT) gradient from baseline to week 30 compared to placebo (p<0.001).
Additionally, mavacamten demonstrated improvement for all secondary endpoints.
Safety results in the trial were consistent with previous studies of mavacamten in symptomatic oHCM, and no new safety signals were reported.
No participants in the study experienced decreases in left ventricular ejection fraction (LVEF) <50 % that required dose interruption.
LianBio licensed rights from MyoKardia, now a wholly owned subsidiary of Bristol Myers Squibb & Co BMY.
In April last year, the FDA approved mavacamten, dubbed Camzyos, for obstructive hypertrophic cardiomyopathy (obstructive HCM) to improve functional capacity and symptoms.
In April 2023, the China National Medical Products Administration (NMPA) accepted with Priority Review a New Drug Application (NDA) for mavacamten for adults with symptomatic oHCM.
Price Action: LIAN shares are up 3.63% at $2.00 on the last check Wednesday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.