PharmAla Biotech Holdings Inc. has entered into an agreement with Merhavim Mental Health Centre in Beer Yaakov, Israel, to supply LaNeo™ MDMA for a clinical trial evaluating MDMA-assisted psychotherapy for Post-Traumatic Stress Disorder (PTSD). The study will compare the efficacy of this treatment in patients with PTSD resulting from early sexual trauma versus PTSD from trauma experienced in adulthood.
Trial Details and Collaboration
Under the agreement, PharmAla will provide its LaNeo™ MDMA clinical research materials to Merhavim at no cost. In return, PharmAla will receive full data licensing rights for all data generated during the clinical trial. These rights will be used for regulatory and commercial purposes. MAPS Israel, a non-profit organization dedicated to psychedelic research and education, is also a partner in this trial.
Nicholas Kadysh, CEO of PharmAla Biotech, stated, "The recent announcement of a cease-fire in the Gaza conflict means that now is the time to work towards healing. We look forward to supporting Merhavim in their clinical trial, which we believe will help patients in Israel, and ultimately worldwide."
Focus on Trauma
The trial, titled “MDMA Assisted Psychotherapy for PTSD of Early Sexual Trauma Compared to All Trauma in Adulthood,” aims to explore whether the timing of trauma affects the response to MDMA-assisted psychotherapy. While existing data supports MDMA's efficacy in treating PTSD, this trial will specifically examine its impact on recent versus aged trauma.
"There is now an incredibly deep and broad set of clinical data proving MDMA’s efficacy in the treatment of Post-Traumatic Stress Disorder, and PharmAla works day-in and day-out to expand that data with our customers and research partners. However, to the best of our knowledge, this will be the first trial to explicitly examine MDMA’s efficacy in the treatment of recent versus aged trauma," added Kadysh.
PharmAla's Role and Future Opportunities
PharmAla intends to ship its LaNeo MDMA to Merhavim, pending regulatory approvals. The company is also open to further collaborations with MAPS Israel on future research endeavors. PharmAla provides researchers with tools and information regarding drug product quality to facilitate clinical trial registrations and IRB approvals.
PharmAla is focused on the research, development, and manufacturing of MDXX class molecules, including MDMA, and is currently the only company provisioning clinical-grade MDMA for patient treatments outside of clinical trials.
