Emyria Limited

Emyria’s Specialist Psychiatrist Granted Authorised Prescriber Status in MDMA-Assisted Therapy for PTSD

Emyria Limited (ASX: EMD) (“Emyria”, or the “Company”) focused on delivering and developing new treatments for mental health and select neurological conditions, is pleased to announce the Company’s distinguished psychiatry specialist has been granted "Authorised Prescriber" status by the Therapeutic Goods Administration (TGA). The authorisation enables the prescribing of MDMA according to an ethics committee endorsed care model developed by Emyria 1 and within the strict regulatory framework established by the TGA for the treatment of Post-Traumatic Stress Disorder (PTSD). 2


HIGHLIGHTS

  • Emyria's key specialist has been granted "Authorised Prescriber" approval from the TGA
  • Authorisation reflects Emyria's dedication to mental health care under strict regulatory, ethical, and safety standards
  • Achieving Authorised Prescriber status for MDMA-assisted therapy in PTSD care signifies a strategic step towards expanding Emyria's service offerings
Dr. Michael Winlo, CEO and MD, commented: "This authorisation demonstrates Emyria’s commitment to evaluating emerging treatments within the strict regulatory framework set by the TGA.

Emyria’s expertise and track record in innovative clinical service development and Real-World Data capture uniquely positions us to evaluate new therapeutic options in a safe and responsible way. Achieving Authorised Prescriber status showcases Emyria's capacity for impactful and responsible growth in the field of mental health treatments."

Initial focus on Post-Traumatic Stress Disorder (PTSD):

PTSD affects approximately 1 million Australians 3. With up to one third of patients failing to benefit from conventional therapies, there is a growing need for more effective treatments. MDMA-assisted therapy (MDMA-AT) is being evaluated as a treatment for PTSD and multiple Phase 3 clinical trials have been conducted by MAPS in the USA. 4, 5

Emyria is currently studying MDMA-AT therapy for PTSD in an ethics-approved clinical trial (EMDMA-001). Experience with the trial has informed a unique delivery model for Emyria’s Authorised Prescriber program.

Authorised Prescribers must adhere to stringent TGA guidelines to ensure the highest level of patient care and safety. The authorisation is part of Emyria’s broader commitment to increasing options for mental health through robust clinical research and ethical practice.

A presentation explaining how the Authorised Prescriber milestone fits into Emyria’s broader strategy will be available on the ASX platform.

Risks associated with the use of MDMA

All medicines carry risks and specialist prescribers, such as registered psychiatrists, are best placed to assess the suitability of a new medication against a patient’s individual circumstances and medical history before proceeding. Adverse effects of MDMA include high blood pressure, increased pulse rate, faintness, and panic attacks, and in some rare cases it can cause loss of consciousness or trigger seizures. Other side effects include involuntary jaw clenching, decreased appetite, restless legs, nausea, headache, sweating and muscle/joint stiffness. These effects are unlikely at low doses in the treatment regimens used in psychedelic-assisted psychotherapy while appropriately managed in a controlled environment with direct medical supervision.


Click here for the full ASX Release

This article includes content from Emyria Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.

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AbbVie and U of T Mississauga's SpinUp Announce Neuropeutics Inc as First AbbVie Biotech Innovators Award Recipient

AbbVie and U of T Mississauga's SpinUp Announce Neuropeutics Inc as First AbbVie Biotech Innovators Award Recipient

  • Following a national competition, AbbVie and SpinUp – the University of Toronto's lab-based, life sciences accelerator – announce Neuropeutics Inc as recipient of first AbbVie Biotech Innovators Award
  • Neuropeutics Inc receives a year of laboratory space and equipment at no cost, as well as access to support and mentorship

AbbVie (NYSE: ABBV) in partnership with the University of Toronto's SpinUp, are pleased to announce Neuropeutics Inc as the recipient of the AbbVie Biotech Innovators Award, a national prize to help foster innovation and support growth in Canada's life sciences sector. Following a competitive selection process, the award, funded by AbbVie, has been granted to Neuropeutics Inc for developing small molecules preventing and reversing protein aggregation as therapeutics for neurodegenerative diseases.

AbbVie Biotech Innovators Award. (CNW Group/AbbVie Canada)

"We are delighted to have this opportunity to collaborate with a global biopharmaceutical company such as AbbVie, and the University of Toronto's SpinUp, to advance Neuropeutics' therapeutic research and development across multiple neurodegenerative diseases. At Neuropeutics, we are committed to developing targeted therapies to extend neurodegenerative disease patients' survival and improve their quality of life. This award allows us to pursue that mission with greater momentum," said Dr. Marc Shenouda , CEO & Co-Founder of Neuropeutics Inc.

Neuropeutics Inc's scientific entrepreneurial spirit directly aligns with the mandate of the AbbVie Biotech Innovators Award to foster research, innovation and growth within Canada's life sciences sector. A hallmark of neurodegenerative diseases is protein aggregation. One such protein is TDP-43, a normally nuclear DNA/RNA binding protein, which in disease conditions becomes mislocalized and forms cytoplasmic aggregates causing neuronal toxicity. Neuropeutics Inc has developed a novel strategy to address diseases such as: Amyotrophic Lateral Sclerosis (ALS), Frontotemporal dementia, Alzheimer's disease, Huntington's disease and Parkinson's disease.

"It was impressive and motivating to see the variety of entries and the calibre of early-stage biotech companies who applied for the Award. We thank all who participated in this life science competition," said Rami Fayed, Vice President and General Manager of AbbVie Canada. "After a rigorous evaluation process, it is with great pleasure that we are announcing that Neuropeutics has been named the recipient of the AbbVie Biotech Innovators Award for its pioneering work in neurodegenerative diseases. We look forward to supporting the journey of Neuropeutics, in collaboration with SpinUp, to accelerate their efforts to deliver life-changing innovation to patients."

"Congratulations to Neuropeutics on being the first AbbVie Biotech Innovators Award recipient, and welcome to SpinUp – the University of Toronto's wet lab incubator," said France Gagnon , Vice-Principal, Research and Innovation at the University of Toronto Mississauga. "This is the place where the potential of Neuropeutics' work in neurodegenerative diseases can be realized and the impact on life sciences can be game changing. We are pleased to collaborate with AbbVie, a global leader in the biopharmaceutical industry, to offer this unique opportunity to this competitively chosen startup."

The AbbVie Biotech Innovators Award was launched in 2024 in collaboration with SpinUp, a purpose-built laboratory for chemistry and biological work or wet lab incubator at the University of Toronto . The Award is to support early-stage Canadian biotechnology startup companies with the potential to generate transformational therapies in areas that align with AbbVie's therapeutic areas of focus: immunology, oncology, neuroscience, and eye care. Neuropeutics Inc will receive a year of laboratory space at no cost, in addition to access to SpinUp's core equipment, services, entrepreneurship programming, and research talent community at the University of Toronto . Neuropeutics Inc will also benefit from mentorship by AbbVie's scientific and business executives.

For more information on the AbbVie Biotech Innovators Award, please visit: https://spinup.utm.utoronto.ca/biotech-innovators-award/ .

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.

For more information about AbbVie, please visit us at www.abbvie.ca . Follow AbbVie Canada on Instagram or find us on LinkedIn .

About SpinUp
SpinUp is the first wet lab startup incubator at the University of Toronto , Canada's leading centre for learning and discovery and one of the world's top-two universities for health science productivity . SpinUp is purpose built to drive life science innovation. It offers early-stage start-ups access to outstanding and highly subsidized wet lab space, equipment, entrepreneurship programming and expertise at a brand new, state-of-the-art research facility at U of T's Mississauga campus. Visit our website at spinup.utm.utoronto.ca and connect with us on Instagram and LinkedIn .

SpinUp is proudly part of U of T Entrepreneurship , a network of 12 accelerators across three campuses. Over the past 10 years, this network has supported more than 1,200 capital-backed companies, which have created 17,000 jobs and raised $12 billion in external investment. U of T now launches more research-based start-ups than any university in North America outside of MIT . The AbbVie Biotech Innovators Award is part of U of T Mississauga's Blue Ticket program at SpinUp, which provides a one-year SpinUp membership.

About Neuropeutics Inc  
Neuropeutics is a for-profit Canadian pharmaceutical company developing targeted therapies to extend neurodegenerative disease patients' survival and improve their quality of life. To learn more, please visit us at www.neuropeutics.ca , contact us at info@neuropeutics.ca , and connect with us on LinkedIn .

Neuropeutics Inc CSO & co-founder Dr. Janice Robertson (left) and Dr. Marc Shenouda, CEO & Co-Founder. (CNW Group/AbbVie Canada)

SOURCE AbbVie Canada

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