PharmAla Biotech Holdings Inc. has secured a significant contract to develop and supply a novel 20mg formulation of its LaNeo™ MDMA for a groundbreaking military PTSD treatment trial. The research, funded through the Defense Appropriations Act, will be conducted by the STRONG STAR Consortium at the University of Texas Health Science Center at San Antonio (UT Health San Antonio).
The development marks a crucial advancement in PTSD treatment research, particularly for military populations. "This DoD-funded project has the potential to be a game-changer for the treatment of PTSD in active duty military populations," stated Dr. Alan Peterson, professor of psychiatry and behavioral sciences at UT Health San Antonio and director of the STRONG STAR Consortium.
Novel Dosing Strategy for Enhanced Treatment Flexibility
The new 20mg clinical drug product dose of LaNeo™ MDMA represents a significant innovation in MDMA-Assisted Therapy (MDMA-AT). This lower-dose formulation, alongside the existing 40mg version, will provide clinicians with greater flexibility in treatment protocols. The expanded dosing options are particularly crucial for clinical trial practitioners and, eventually, for clinicians administering MDMA-AT in jurisdictions where such treatment is permitted.
Military-Focused Research Initiative
The STRONG STAR Consortium, a multidisciplinary research network, brings together expertise from military, civilian, and VA institutions nationwide. The organization focuses on developing and evaluating interventions for psychological health conditions affecting military personnel, veterans, and first responders.
Nicholas Kadysh, CEO of PharmAla Biotech, emphasized the company's commitment to the project: "PharmAla is absolutely thrilled to be providing clinical drug product to the successful applicants in the recent $10M Department of Defense grant process. Having worked hard to support them during the grant application process, we will work even harder to ensure that the trials have the drug product they need to achieve successful results."
Multi-Site Clinical Implementation
The trial will be conducted at two prestigious institutions: UT Health San Antonio and Emory University. This multi-site approach will help ensure robust data collection and comprehensive evaluation of MDMA-AT's efficacy in treating PTSD among active-duty military personnel.
The research represents a significant step forward in addressing mental health challenges within military populations, combining innovative pharmaceutical development with targeted therapeutic applications. As one of the first studies examining MDMA-AT specifically in active-duty military personnel, the results could have far-reaching implications for military mental health treatment protocols.
