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Emyria signs real-world data agreement with Zelira Therapeutics for insomnia drug Zenivol

Emyria will provide real-world data that will complement the existing clinical data-pack for Zenivol™ and be used to inform further clinical development and, ultimately, the path to product registration.

Emyria Ltd - Emyria signs real-world data agreement for insomnia drug Zenivol with Zelira Therapeutics
The term of the agreement is for 12 months with an option to extend the subscription fees on an ongoing basis

Emyria Ltd (ASX:EMD), formerly Emerald Clinics Ltd, has signed an agreement with Zelira Therapeutics Ltd (ASX:ZLD) to collect data from patients treated with insomnia drug Zenivol™ through Emyria’s specialist clinical services.

Zelira specialises in the development of cannabinoid-based medicines for treatment of a variety of medical conditions including insomnia, autism and chronic non-cancer pain while Emyria develops and commercialises real-world evidence assets by leveraging its unique clinical services and data expertise.

Under the partnership, Emyria will collect longitudinal data on patients prescribed Zenivol™ for the treatment of insomnia and related conditions.

De-identified patient data will include details regarding diagnosis and co-morbidities, concomitant medications, dosages prescribed to patients and their responses to Zenivol™ treatment assessed using various clinical and subjective endpoints including the Insomnia Severity Index (ISI) questionnaire.

“Real-world evidence”

Emyria managing director Dr Michael Winlo said: “We’re delighted to be working with Zelira Therapeutics, to realise the potential for a real-world evidence asset that will help to progress the commercialisation and regulatory acceptance of its medicinal cannabis products.

“Partnering with clinically-focused companies, such as Zelira, further supports our model of generating high-quality patient data to accelerate development of unregistered medicines for patients.”

Agreement terms

Zelira will pay Emyria up to $100,000 comprising an upfront fee of $50,000 along with a subscription fee for each patient enrolled in the study, up to a maximum of 100 participants.

The initial term of the agreement is for 12 months, with Zelira having an option to extend the term to capture the required minimum of data for each patient.

Complementing clinical data

Emyria will provide real-world data that will complement the existing clinical data-pack for Zenivol™ and be used to inform further clinical development and, ultimately, the path to product registration.

Zenivol™ recently received TGA approval for prescription to patients through its Special Access Scheme and the Emyria data will add further value to the global commercialisation opportunities for the company.

The partnership reinforces both Zelira’s competitive advantage for bringing high-value cannabinoid medicines to market supported by clinical and real-world patient data as well as reinforcing Emyria’s model of commercialising high-quality, real-world evidence.

Path to registration

Zelira managing director Richard Hopkins said: “Australia’s commitment to developing a highly regulated market for prescription cannabis medicines means this country is a global leader in collection of high-quality real-world data relating to patients treated with medicinal cannabis.

“We believe Emyria’s approach to collection and curation of patient data, underpinned by its clinical services, is best-in-class.

“Being able to access real-world data, in real-time, from patients treated with Zenivol™ will have immediate benefit for our go-to-market strategy.

“This information will also inform the design of future clinical trials, reduce the risks and costs of development and accelerate the path to regulatory approval.

“These key value-adding features highlight the competitive advantages of our unique ‘Launch, Learn and Develop’ model, further differentiating Zelira from its global peers enhancing the commercialisation opportunities for the company.”

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