Emyria Ltd (ASX:EMD) has ticked off a major milestone with the successful recruitment and consent of the first patient for its Phase 2B MDMA-assisted therapy trial for post-traumatic stress disorder (PTSD).
Important step forward
This development marks an important step for the company in the development and delivery of MDMA-assisted and psilocybin-assisted therapies to address significant mental health challenges.
The EMDMA-001 trial has been designed to assess the safety, efficacy and cost-effectiveness of MDMA-assisted therapy for PTSD. It aims to generate vital data that will strengthen Emyria's position as a leader in providing psychedelic-assisted therapy within a comprehensive multidisciplinary clinical service.
The trial will support applications for Authorised Prescriber status for Emyria's team of skilled psychiatrists, enabling the establishment of a commercial delivery model.
Considerable participant interest
The company has already identified additional patients from the existing database of The Pax Centre, which Emyria recently acquired – but to ensure meticulous care and comprehensive monitoring for each participant, Emyria will stagger the recruitment process.
There has also been considerable interest from potential participants, indicating a strong participant base for the trial.
In conjunction with the trial, Emyria is launching a unique patient data registry using its state-of-the-art data platform called Palantir Foundry.
This registry will facilitate safety monitoring, research, and engagement with payers, supporting Emyria's commitment to delivering innovative and compliant mental health treatments.
MDMA importation underway
Importation of MDMA has commenced, after the company secured essential approvals from the Office of Drug Control (ODC) and the Australian Therapeutic Goods Administration (TGA).
The MDMA used in the study is an unregistered GMP-grade medicine, as there are currently no approved MDMA medications.
This importation process represents a significant accomplishment for Emyria and speaks to the company's expertise in navigating a complex regulatory landscape.
It not only represents a significant step forward for the EMDMA-001 trial but also underscores Emyria's ability to deliver innovative and groundbreaking mental health treatments.
During the EMDMA-001 trial, participants will undergo up to three MDMA-assisted therapy sessions over a three-month period.
They will also receive comprehensive preparation and integration sessions before, during, and after the treatment. A follow-up period of 12 months post-treatment will be conducted to assess the long-term effects.
The trial has no maximum participant limit, and Emyria has secured an adequate supply of MDMA for an initial cohort of up to 70 adult participants, all of whom have been diagnosed with PTSD.
While the trial will primarily take place at Emyria's Pax Centre, additional sites may be added once they are suitably prepared.
The company has underscored that the study adheres to international best practice standards and fully complies with the principles of Good Clinical Practice (GCP) outlined by the International Council for Harmonisation (ICH).