Emyria Ltd (ASX:EMD) is trading higher after being selected to conduct an observational trial for patients diagnosed with Autism Spectrum Disorder (ASD) treated with Zelira Therapeutics (ASX:ZLD) HOPE™ range of products.
The trial, which will be one of the largest medicinal cannabis studies ever undertaken involving a specific range of products in patients diagnosed with ASD, has a study design that will facilitate strategic engagement with key stakeholders in the autism community and streamline patient access through Emyria’s national network of specialist medical clinics – Emerald Clinics.
These efforts will complement and augment the recent launch of HOPE™ in the Australian market.
The company's shares are trading 15% higher at 8.2 cents.
“Un-met clinical need”
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.
“Partnering with clinically-focused companies, such as Zelira, further supports our model of generating high-quality patient data to accelerate development of improved cannabis medicines for patients with unmet needs.”
Real-world longitudinal data
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 HOPE™ treatment as measured using standard ASD clinical and behavioural endpoints.
Zelira will pay Emyria fees of $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 term of the agreement is for 12 months with an option to extend the subscription fees on an ongoing basis.
“One of largest observational studies undertaken”
Zelira managing director Richard Hopkins said: “We are excited to secure this agreement with Emyria to further augment our launch of HOPE™ in Australia, particularly after the successful launch of these products in the USA.
“This will be one of the largest observational medicinal cannabis studies ever undertaken in patients with ASD involving a specific range of products.
“This focused 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.
“The 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.”