Toronto, ON – February 27, 2025 - PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), is proud to announce that its previously announced (See press release of October 8, 2024) contract to the University of Texas Health Science Center at San Antonio (UT Health San Antonio) will move forward, with the trial having been funded by a grant via the Defense Appropriations Act.
“This DoD-funded project has the potential to be a game-changer for the treatment of PTSD in active duty military populations,” said Alan Peterson, PhD, professor of psychiatry and behavioral sciences at UT Health San Antonio and director of the STRONG STAR Consortium.
The consortium, led by UT Health San Antonio, is a national research network focused on finding the best preventions and treatments for psychological health issues affecting military members, veterans and first responders.
The contract, as previously announced, will see PharmAla develop a new 20mg clinical drug product dose of its LaNeo™ MDMA; This will allow significantly more variability in dosing for clinical trial practitioners, and eventually, for clinicians treating patients with MDMA-Assisted Therapy (MDMA-AT) in those countries where it is currently practicable. This study will be one of the first to examine the effects of MDMA-AT in a novel patient population, active-duty military personnel.
“We are incredibly excited to provide STRONG STAR at the UT Health San Antonio and Emory University (the two sites in this trial) with both our 40mg and newly-developed 20mg LaNeo MDMA™ Capsules,” said Nicholas Kadysh, CEO, PharmAla Biotech. “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.”
About STRONG STAR
The South Texas Research Organizational Network Guiding Studies on Trauma and Resilience, or STRONG STAR, is a multidisciplinary and multi-institutional research consortium funded by the U.S. Departments of Defense (DoD) and Veterans Affairs (VA) and other agencies to develop and evaluate the most effective early interventions possible for the prevention, detection, diagnosis, and treatment of psychological health conditions in military personnel, veterans, and first responders.
Under the leadership of The University of Texas Health Science Center at San Antonio, STRONG STAR brings together the expertise of a world-class team of military, civilian, and VA institutions and investigators from across the country, unifying the critical mass of talent required to make significant research advances and to develop and deliver treatment programs that are relevant, effective, and feasible in military and VA settings.
PharmAla Biotech Holdings Inc. (CSE: MDMA) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials, and to develop novel drugs in the same class. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators. Our team of dedicated professionals includes regulatory experts, scientists, and biomanufacturing professionals. PharmAla has built what it believes to be North America’s first cGMP MDMA value chain, encompassing GMP manufacturing of Active Pharmaceutical Ingredient (API), and drug product formulation. PharmAla’s research and development unit has also begun preclinical research into two patented Novel Chemical Entities (NCEs) based on MDXX class molecules, with proof-of-concept research currently ongoing at the University of Arkansas Medical School.
Nicholas Kadysh, CEO
press@pharmala.ca