Zelira Therapeutics Ltd (ASX:ZLD) (OTCQB:ZLDAF) (FRA:G1G) has entered into an agreement with Emyria Ltd (ASX:EMD), to conduct an observational trial for patients diagnosed with autism spectrum disorder (ASD) treated with Zelira’s HOPE™ range of products.
The observational trial will be one of the largest medicinal cannabis studies ever undertaken involving a specific range of products in patients diagnosed with ASD.
Emyria is recognised as a global leader in the collection and translation of real-world patient data (RWD) and also owns and manages a national network of specialist medical clinics.
Complement existing data pack
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.
“The focused approach will generate very high-quality RWD that will complement our existing data-pack for HOPE™ and inform our global marketing strategy in realtime.
“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.
“The agreement builds upon our existing partnership with Emyria by further leveraging their leading RWD expertise.
“Emyria’s ability to expand and adapt their model to facilitate a large observational trial highlights the strategic value of this relationship.
“These key value-adding features highlight the competitive advantages of our unique ‘Launch, Learn and Develop’ model, further differentiating Zelira from its global peers, and enhancing the commercialisation opportunities for the company.”
Realise potential of RWD
Emyria managing director Dr Michael Winlo added: “We’re delighted to be working with Zelira Therapeutics again, this time to realise the potential of our real-world evidence data products to help progress the commercialisation and regulatory understanding of Zelira’s medicinal cannabis treatments.
“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.”
Study design
The study design will facilitate strategic engagement with key stakeholders in the autism community and streamline patient access via 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.
Under the terms of the agreement, Emyria will provide Zelira with longitudinal RWD collected from ASD patients prescribed a HOPE™ product.
Data will include patient’s efficacy and safety relating to comorbidities, concomitant medications, dosing information and patient responses to HOPE™ treatment as measured using standard ASD clinical and behavioural endpoints.
Terms of the deal
Zelira will pay Emyria fees of $115,000 in two instalments 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.
