Emyria Ltd (ASX:EMD), a data-backed drug development company, has signed a letter of intent with Seattle-based biometric software and hardware company Cydelic to develop a biometric monitoring platform to assist patients and their therapists during psychedelic-assisted therapy.
The partnership will work across Cydelic’s 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.
MDMA for PTSD trial
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.
It will also be one of the first programs in the world to incorporate remote patient monitoring in MDMA-assisted therapy.
EMDMA-001’s leading psychotherapist is MMA’s clinical lead Nigel Denning, who has completed therapist training with the Multidisciplinary Association for Psychedelic Studies (MAPS)\ and is a co-lead of MMA’s Certificate of Psychedelic Assisted Therapy (CPAT).
TGA decision increases urgency
The recent US Therapeutic Goods Administration (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. It also highlights the importance of replicating statistically significant clinical trial results in real-world settings.
Emyria has plans to advance its proprietary MDMA-analogue program to deliver new registered treatments for a range of psychiatric and neurological indications.
Cydelic’s remote monitoring technology will be incorporated into Emyria’s Real-World Data platform, powered by Palantir Foundry, to help track multiple physiological parameters before, during and after an MDMA-assisted therapy trial for PTSD (EMDMA-001) developed with MMA.
Physiological tracking of patients
The company plans to track physiological indicators using ‘wearable’ technology to help it with patient selection, safety monitoring during treatment, dose-response analysis as well as tracking long-term safety and durable changes to quality of life.
Emyria plans to use a validated system for tracking patient physiology alongside psychotherapy, to help therapists monitor patient safety, while also supporting the standardisation, scalability, registration and reimbursement of psychedelic-assisted therapies.
Physiological measures that Emyria plans to track using the Cydelic platform include:
- Heart rate and heart rate variability – these measures can change in acute emotional or physiological distress;
- Activity and sleep – these may be helpful in understanding changes in sleep routines by comparing patterns before and after treatment;
- Electrothermal activity and skin temperature – these indicators may help measure depth of emotional response; and
- EEG (brainwaves) – there are many EEG biomarkers associated with PTSD, the most common being alpha band-related parietal asymmetry, which is an alpha power imbalance between the left and right hemispheres within the parietal lobe.
The companies hope to develop a deeper understanding of how to use these wearables in psychedelic-assisted therapy to build unique and robust real-world data to assist with safety and efficacy research.
The partnership will provide Emyria with unique wearable and biometric data during planned trials. This data, when combined with clinical outcomes measurements, will be owned by Emyria and will extend the depth and utility of Emyria’s real-world data.
Commercial objectives
A major commercial objective is to register the most promising new treatments with global regulators. Generating safety and efficacy evidence for these new treatments will help Emyria pursue this goal successfully.
Emyria will control and own all clinical and device data, and Cydelic will receive anonymised, non-clinical, device data for technical support only.
Under the non-binding terms of the letter of intent, Cydelic is to develop a formal contract within the next 30 days to cover the provision and configuration of remote monitoring devices (wearables), and proprietary software integrating data received from these devices.
Each party will bear its own costs for the development of the contract, which will be prepared over the next 30 days. If no agreement is reached within that time, the LOI will lapse.
“Psychedelic-assisted therapy is showing tremendous promise for patients suffering the most debilitating mental health challenges," managing director Dr Michael Winlo said.
“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 - Emyria is involved in all of these areas.”
“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 and improve clinical outcomes. 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.”