Emyria Limited has been selected to conduct an observational trial for patients diagnosed with Autism Spectrum Disorder (ASD) and treated with Zelira Therapeutics’ recently launched Hope range of products.
The trial will be one of the largest medicinal cannabis studies ever undertaken involving a specific range of products in patients diagnosed with ASD.
The study design will facilitate strategic engagement with key stakeholders in the autism community and streamline patient access via Emerald Clinics, Emyria’s national network of specialist medical clinics.
Under the terms of the agreement, Emyria will provide Zelira with real-world longitudinal data collected from ASD patients prescribed a Hope product. Data will include efficacy and safety insights relating to co-morbidities, concomitant medications, dosing information and patient responses to treatment with Hope as measured using standard ASD clinical and behavioural endpoints.
Zelira will pay Emyria $115,000 over the first six months as well as a subscription fee for each patient enrolled in the study, up to a maximum of 150 participants. The 12-month agreement has an option to extend the subscription fees on an ongoing basis.
Emyria managing director Dr Michael Winlo said: “We’re delighted to be working with Zelira Therapeutics again, this time to apply our real-world evidence data products and trial-ready clinical network to help progress the commercialisation and regulatory understanding of Zelira’s medicinal cannabis treatments in an area of unmet clinical need.
Zelira managing director Dr Richard Hopkins said: “This will be one of the largest observational medicinal cannabis studies ever undertaken in patients with ASD involving a specific range of products. This focussed approach will generate very high-quality data that will complement our existing data-pack for Hope and inform our global marketing strategy in real-time.
He added: “This information will also inform the design of possible future clinical trials, reduce the risks and costs of development and accelerate the path to regulatory approval.”