Emyria Ltd (ASX:EMD) is likely to benefit from the Therapeutic Goods Administration (TGA)’s to down-schedule MDMA and psilocybin to Schedule 8 'Controlled Medicines' from July 2023.
The clinical-stage biotech would be well-positioned to accelerate patient access to MDMA-assisted therapies following the TGA’s regulation changes and investors have responded positively, sending shares as much as 60.53% higher this morning to $0.305.
Rescheduling of MDMA opens a pathway to registration and reimbursement for MDMA and its analogues.
Collaboration with partners
Emyria will collaborate with clinical partners to improve patient access and ongoing research while continuing its drug discovery program in Australia and the United States to identify novel, MDMA-like compounds with the greatest therapeutic potential.
Emyria is well positioned to advance and help commercialise MDMA-assisted therapies via:
- established clinical & data infrastructure, which can support qualified Authorised Prescribers and therapists to deliver MDMA-assisted therapy safely and at scale; and
- real-world data generation during treatment, which can inform care model innovation, drug registration programs and advance Emyria’s novel, advanced MDMA-inspired drug discovery program with partner the University of Western Australia.
"Timely and world-leading"
Emyria’s managing director Dr Michael Winlo said of the TGA’s decision, “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 large and positive impact for patients globally.
TGA amendments
The TGA amendments will:
- add psilocybin and MDMA to Schedule 8, permitting their use as Controlled Drugs only for treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD), respectively;
- add entries in Appendix D to restrict access to the substances under Schedule 8:
- they can only be prescribed for the above conditions by specialist psychiatrists who have obtained approval to use the substances for treating these conditions from a human research ethics committee (HREC), and then been authorised by the TGA under the Authorised Prescriber Scheme to prescribe the substances for these conditions.
- they can also be used in clinical trials into these conditions (they are currently only accessible for clinical trials as Schedule 9 substances)
- the possession of the substances as Schedule 8 drugs without authority will be illegal (for example, possession other than in accordance with a legal prescription).
Moving forward
Emyria has a history of continuing to move its ambitions forward in the wake of TGA decisions.
A similar rescheduling of medicinal cannabis from Schedule 9 to Schedule 8 occurred in 2016 and while this was occurring, Emyria 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 comprehensive Phase 2B clinical trial protocol for MDMA-assisted therapy.
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.
Further to this, Emerald Clinics (Emyria’s clinical service subsidiary) has successfully applied for 16 Authorised Prescriber determinations relating to the provision of unregistered cannabinoid medicines to patients with unmet needs.
Emyria has also launched an MDMA-inspired drug discovery program with the University of Western Australia. The partnership has now developed, screened and filed 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.
Preclinical studies are underway to identify candidates for next-generation MDMA-assisted therapy and treatments for other major neurological conditions, creating a robust and unique preclinical research and development pipeline.