Australian clinical-stage biotechnology company Emyria is planning to expand its MDMA programs after the Therapeutic Good Association (TGA) reclassified MDMA and psilocybin to a Schedule 8 medicine.
During the TGA’s deliberation, Emyria reports it established a network of clinical partners, developed a supply chain for Schedule 8 and 9 medicines, identified numerous suppliers of GMP-MDMA (patient-ready), and developed a phase 2B clinical trial protocol for MDMA-assisted therapy.
The company says this protocol can now be adapted to support specialist psychiatrists meet the requirements for Authorised Prescriber status. This process requires an evaluation by a Human Research Ethics Committee. To date, Emyria’s clinical services subsidiary Emerald Clinics have applied for 16 Authorised Prescribers determinations relating to the provision of unregistered cannabinoid medicines to patients with unmet needs.
Additionally, Emyria and the University of Western Australia launched an MDMA-inspired drug discovery program. This partnership has now developed, screened and filed intellectual property (IP) for over 140 proprietary, neurologically active and novel MDMA-like compounds with the potential to become registered treatments for a range of neuropsychiatric disorders and new psychedelic treatments.
“Emyria is well-prepared to support the safe provision of MDMA-assisted therapies under this new change”
Commenting on the MDMA programs, Emyria Managing Director Dr Michael Winlo said: “The mental health crisis, in Australia and around the world, continues to have untold cost, which is why the TGA’s move to reschedule MDMA and psilocybin is timely and world-leading.
Emyria is well-prepared to support the safe provision of MDMA-assisted therapies under this new change as the only ASX company with a clinical service specialising in unregistered medicines and real-world data generation. Emyria has also developed a comprehensive MDMA-assisted therapy protocol that can now support specialists.
Further, Emyria is also leading a wave of future innovation via our active MDMA-inspired drug discovery program in partnership with the University of Western Australia.
We believe the TGA’s decision will allow Emyria, and its partners, to build a stronger evidence base for treating mental health conditions with psychedelics and make a larger and positive impact for patients globally.”
Emyria also reports the rescheduling of MDMA opens a pathway to registration and reimbursement for MDMA and its analogues. The company will now collaborate with clinical partners to improve patient access and ongoing research while continuing the drug discovery program in Australia, and the US to identify novel, MDMA-like compounds with the greatest therapeutic potential.
Preclinical studies are also currently underway to identify candidates for next-generation MDMA-assisted therapy, and treatments for other major neurological conditions. The company says this will create a robust, and unique preclinical research and development pipeline.
Emyria is a clinical drug development and care delivery company focused on accelerating drug development, and improving patient outcomes in neuroscience and mental health. The company achieves this goal through drug development, new drug discovery, and proprietary real-world data.