Emyria to expand real world data assets for MDMA therapy trials

Dr. Michael Winlo, Managing Director, Emyria

Emyria Limited (ASX: EMD) (Emyria or the Company), a data-backed drug development and care delivery company, is pleased to announce it has entered into a letter of intent with innovative biometric software and hardware company, Cydelic, based in Seattle, USA.

Cydelic is developing a biometric monitoring platform to assist patients and their therapists before, during and after psychedelic-assisted therapy.

Highlights from the Emyria Limited and Cydelic deal

  • Emyria signed a letter of intent (LOI) with Cydelic, a developing tools and technologies that help track the wellbeing of patients before, during and after psychedelic-assisted therapy
  • Emyria plans to work with Cydelic across all of its psychedelic-assisted therapy programs to capture unique biometric data that can assist with real-time patient safety and dose response analysis and registration of psychedelic-assisted therapy
  • Emyria’s phase 2b MDMA-assisted therapy trial for severe Post Traumatic Stress Disorder (PTSD), EMDMA-001, developed with registered charity Mind Medicine Australia (MMA), will be the first program to incorporate Cydelic technology.
  • And is expected to be one of the first programs in the world to incorporate remote patient monitoring within MDMA-assisted therapy
  • EMDMA-001’s leading psychotherapist is MMA’s clinical lead Nigel Denning who completed therapist training with the Multidisciplinary Association for Psychedelic Studies (MAPS) this week and is a co-lead of MMA’s Certificate of Psychedelic Assisted Therapy (CPAT)
  • The recent TGA decision not to reschedule MDMA from Schedule 9 to 8 at this time places greater importance on clinical trials and Real-World Data to develop evidence-based practices for these treatments to improve patient access
  • Emyria is committed to advancing its proprietary MDMA-analogue program to deliver new registered treatments for a range of psychiatric and neurological indications

Emyria’s Psychedelic-assisted therapy a top prospect

Emyria’s Managing Director, Dr. Michael Winlo said: “Psychedelic-assisted therapy is showing tremendous promise for patients suffering the most debilitating mental health challenges.”

“The recent decision by the TGA not to reschedule MDMA and psilocybin at this time highlights the important role companies like Emyria, and our innovative partners, will play to further develop these treatments through clinical studies and careful data collection.”

“This will benefit from Real-World Data from wearable technologies and novel treatment development. We are now delighted to be working with Cydelic to add cutting-edge remote monitoring to our psychedelic-assisted therapy programs and clinical trials.”

“Emyria will utilise a suite of remote patient monitoring wearables to track the well-being of patients before, during and after participation in clinical trials, starting with the MDMA-assisted therapy trial for PTSD which has been developed in partnership with Mind Medicine Australia.”

“By paying close attention to a patient’s physiology with remote monitoring we can build a unique Real-World Data asset that can help clinicians optimise the patient experience.”

“It is hoped this unique data can also help with the registration and reimbursement of these treatments. I look forward to updating the market with further progress and results as we advance our development milestones in the coming months.”