Biotechnology company Emyria (ASX: EMD), which develops treatments for mental health and neurological conditions, has newly inaugurated its treatment facility Empax Centre. The centre has been selected as a key site for a clinical trial sponsored by New York-based Transcend Therapeutics.
The trial will evaluate the safety and efficacy of methylone, a novel rapid-acting neuroplastogen known for promoting new nerve cell growth in areas affected by PTSD, depression, and anxiety.
Emyria CEO Dr Michael Winlo said, “We are delighted to work with Transcend Therapeutics on this exciting trial that highlights our dedication to bringing new treatments to our patients while utilising the full capabilities of our Empax Centre. Site selection is international recognition of our team’s unique capabilities and we look forward to working with Transcend Therapeutics and our network of specialists to advance this trial and improve mental health outcomes for patients with severe PTSD.”
Emyria’s Empax Centre is focused on the delivery and evaluation of new treatments for mental health. It provides critical infrastructure for the safe administration and evaluation of new medications in clinical trials and real-world settings.
Transcend Therapeutics is a clinical-stage, neuroscience-focused company developing rapid-acting treatments for neuropsychiatric diseases. The parties have entered into a standard form clinical trial research agreement, which is binding and provides industry-standard termination provisions.
There are no material conditions precedent under the agreement. If the trial proceeds as planned, Emyria expects to recruit at least 20 participants competitively and will provide comprehensive specialist mental health services, including initial screenings, ongoing safety and efficacy assessments, precise dosing, patient monitoring and data entry—tasks that require the expertise of trained psychiatrists and therapists.
Methylone, identified as TSND-201 by Transcend Therapeutics, is a new MDMA analogue that has demonstrated potential in quickly triggering the expression of neuroplasticity genes (that enable modification of the brain cells), including BDNF (Brain-derived neurotrophic factor) 2, 3, and 4, which are vital for recovery in neuropsychiatric disorders.
The Phase 2 trial, titled “An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD”, also known as “IMPACT-2” (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD]), will be conducted in two parts with plans to enrol up to 79 participants at various sites in Australia and the United States. Emyria will receive market-rate fees for specialist work for participants enrolled at Empax Center.
The trial will assess the safety and efficacy of three doses of methylone, with each dose administered one week apart, in participants with PTSD.
Emyria will receive compensation for facilitating the trial, highlighting its expertise in psychological trauma care and clinical trial delivery. This recognition aims to establish Emyria’s leadership in mental health innovation.
Each participant will receive a level of care reflecting the depth and rigour of these services, with fees structured to align with market rates for such specialised work.
Alinda is a Business Reporter for The Sentiment
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