Zelira Leverages Emyria's clinical and data expertise to monitor the safety and efficacy of Zenivol.
Zelira Therapeutics Ltd (ASX: ZLD) is pleased to announce it has entered into an agreement with Emyria Ltd (ASX:EMD), (formerly Emerald Clinics), a leader in the collection and
translation of real-world patient data, to collect data from patients treated with Zenivol™ in Emyria's network of specialist medical clinics.
Under the terms of the agreement Emyria will provide access to real-world longitudinal data collected from patients prescribed Zenivol™ for treatment of chronic 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 data and information collected from patients will complement the existing clinical data-pack for Zenivol™ and be used to inform further clinical development and, ultimately, the path to product registration.
Zelira will pay Emyria 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 term of the agreement is for 12 months with an option to extend the subscription fees on an ongoing basis.
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. Richard Hopkins, Zelira's Managing Director
Zelira's 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.
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."
Emyria's Chief Executive Officer, Dr Michael Winlow, 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."
To learn more about Zelira, visit their company HQ here.
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