SAGE's Huntington's Disease Study Meets Primary Endpoint

Core Viewpoint - Sage Therapeutics announced that its phase II SURVEYOR study for dalzanemdor met its primary endpoint, but the company's shares fell by 2.8% following the announcement [1]. Group 1: Study Objectives and Results - The SURVEYOR study aimed to evaluate the safety of dalzanemdor, assess cognitive impairment in Huntington's disease (HD) patients compared to healthy participants, and understand the relationship between cognitive changes and functional changes [2]. - The study demonstrated a statistically significant difference in HD-Cognitive Assessment Battery (HD-CAB) composite scores between healthy participants and those with HD at baseline, with a small numerical difference observed between dalzanemdor and placebo at day 28 [3][7]. Group 2: Adverse Events and Future Studies - Eleven participants with HD experienced mild to moderate treatment-related adverse events, with no discontinuations due to these events [4]. - Sage is conducting a larger phase II DIMENSION study to evaluate the efficacy of dalzanemdor over a 12-week period, with data expected in late 2024 [8]. Additionally, dalzanemdor is being evaluated in the LIGHTWAVE study for Alzheimer's-related cognitive impairment, with top-line data expected later this year [10]. Group 3: Market Performance and Context - Sage's shares have decreased by 51.1% year-to-date, contrasting with a 6.4% decline in the industry [6]. - The company previously shared results from the PRECEDENT study on dalzanemdor in Parkinson's disease, which failed to meet its primary endpoint, leading management to halt further development for this indication [11].