- Exploratory Phase 2 Trial in Huntington’s Disease patients meets primary, secondary, and exploratory endpoints
- FDA grants Orphan Designation for the treatment of Huntington’s Disease with Azevan’s V1a receptor antagonist
- FDA grants Fast Track status to Azevan’s SRX246 for the treatment of Huntington’s Disease*
*Expanded Access Policy: At Azevan, we are committed to developing our first-in-class V1a receptor antagonist, SRX246, for the treatment of mood and behavior disorders in patients with neurodegenerative diseases, such as Hungtington’s disease. The FDA has granted Fast Track Designation of SRX246 for this use. Our current focus is to complete our ongoing and planned clinical trials to demonstrate safety and efficacy in order to obtain regulatory approval and provide widespread availability of SRX246. Prior to regulatory approval by the U.S. Food and Drug Administration (FDA) and foreign regulatory authorities, patients gain access to investigational treatments, such as SRX246, by participating in clinical trials. Expanded access, also called compassionate use, enables some patients with serious or life-threatening diseases, who would not have otherwise met the enrollment criteria for the clinical trials in progress, to gain access to investigational treatments. Unlike the use of an investigational new drug in a clinical trial setting, the primary purpose of expanded access is to use the investigational drug for patient treatment purposes, rather than to gather data on safety, tolerability and effectiveness. Currently, Azevan does not offer an expanded access program, and does not accept expanded access requests. We believe that access to SRX246 should be limited to controlled clinical trials until such time as its safety, tolerability and effectiveness for a particular indication has been determined and confirmed by regulatory authorities. Patient access to SRX246 outside of a controlled clinical trial may interfere with the conduct of our ongoing and future clinical trials, and may also disrupt the progress of our development program, which would, in turn, delay access to many patients in need. Accordingly, while clinical trials are ongoing, we believe participation in our clinical trials is the only safe and appropriate way to access SRX246.