Emyria has dosed the first patient in the EMDMA-001 trial of its ethics-approved MDMA-assisted therapy (MDMA-AT).
This is the first dosing since the Therapeutic Goods Administration descheduled MDMA in July this year.
The trial will include both the active treatment phase of Emyria’s MDMA-AT programme and the accumulation of real-world data to support further innovation and payer engagement.
The dosing was administered without any safety issues.
Safety and cost-effectiveness measures are the primary endpoints while a comprehensive suite of clinical and quality-of-life measures are secondary endpoints of the study.
The trial will also serve as the foundation for Emyria’s Authorised Prescriber (AP) programme for MDMA-AT by allowing the clinical team to prepare for the programme’s requirements.
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As the trial has now transitioned to active treatment, it not only strengthens Emyria’s AP application but also initiates in offering of clinical evidence.
This evidence further supports payer engagement and the company’s drug development initiatives.
A successfully initiated AP programme for MDMA-AT is expected to expand patient access to Emyria’s new services.
Treatment for post-traumatic stress disorder (PTSD) using MDMA-AT was also found to be safe and effective in the second Phase III study, which was published by MAPS last month.
Emyria lead psychiatrist Dr Jon Laugharne said: “For individuals grappling with PTSD, the current treatment landscape can feel limiting.
“By initiating active MDMA-assisted therapy within an operational private clinic, as opposed to traditional academic settings, we aim to prioritise Real-World patient well-being and learning in order to develop a viable delivery model that can scale.”