Sage Therapeutics is pleased to share with you an important update on the clinical development program for Sage’s investigational drug, SAGE-718. The PERSPECTIVE Program, a set of clinical studies, will evaluate the safety and effect of SAGE-718 on cognitive symptoms in people with Huntington’s disease (HD). The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to SAGE-718 for development as a potential treatment for HD. Fast Track is a process designed to facilitate the development and review of new treatments for serious conditions with unmet medical need such as HD.
The DIMENSION Study, a Phase 2 clinical research study and our first study in the PERSPECTIVE Program, is now open and recruiting in select regions of the United States. The DIMENSION Study is a randomized, placebo-controlled, double-blind study evaluating the safety and effect of SAGE-718 on cognitive symptoms in adults with premanifest or early manifest HD. Cognitive symptoms may include impaired judgment, forgetfulness, difficulty paying attention, and trouble thinking through steps of an activity or complex problems.