Emyria launches drug development program focused on mental health based on real-world evidence analysis

Emyria Limited (ASX:EMD) has launched its initial drug development program focused on mental health following deep analysis of its real-world evidence (RWE) generated from more than 3,000 patients.  The first end-to-end drug development program will encompass a package of clinical evidence, intellectual property (IP) and strategically developed clinical trial protocols.  This program is designed to support the registration of a specific cannabinoid-based medicine for a specific mental health indication with the Therapeutic Goods Administration’s (TGA) Australian Register of Therapeutic Goods (ARTG).  Multiple, unique opportunities Emyria managing director Dr Michael Winlo, said: “We’re very enthusiastic about the launch of our own evidence-based drug development program after an extensive review of the IP landscape, published literature and, of course, our own clinical evidence. “This work has identified multiple, unique opportunities to develop treatments for specific mental health concerns as well as novel IP, which we have protected. “We are also well placed to rapidly register these treatments, given the unparalleled access we have to large patient populations across our independent clinical network, the clinical-trial grade data systems and remote monitoring technologies we have developed and our in-house expertise in data analysis, clinical trial design and drug registration. “We expect this initial program to increase the availability of registered drug options for patients with mental health concerns and develop significant shareholder return in a highly capital-efficient manner. Growing global health concern “Mental health is a growing global health concern affecting many of our current patients and this drug development program complements our recent partnership with Mind Medicine Australia focusing on the development of new treatment options for patients with major mental health concerns. “We look forward to updating the market with our progress towards registration and commercialisation of this program while we support our current partners to advance their own registration programs.” Significant market opportunity Currently, most medicinal cannabis products available in Australia are 'unapproved therapeutic goods', which means they have not been assessed by the TGA for quality, safety or effectiveness. Most of these products, therefore, can only be accessed via Special Access Schemes (SAS) or from Authorised Prescribers. A successfully registered treatment would be accessible to patients via routine prescription or, if the TGA allows, over-the-counter pathways, representing a significant potential market opportunity. Data analysis A decision to launch the program was made following a deep, longitudinal analysis of Emyria’s extensive RWE data assets, which have been co-developed with patients treated by its Emerald Clinics service. The analysis revealed statistically significant dose-response data in a target patient population using a series of globally validated mental health measures. These data insights effectively replace the need for exploratory therapeutic clinical trials, and provide quality safety and efficacy data that will allow registration trials to be accelerated as the effective dose range and target patient population has now been identified from the aggregated patient usage data. On average, over 150 data points are collected per visit from each patient. Patients in the cohort analysis were regularly administered the DASS-21 (Depression Anxiety, Stress Scale - 21 elements) - a quantitative measure of distress. Data generated from the study analysis showed highly statistically significant improvements in the anxiety component of patients’ DASS-21 scores (P<0.001) when treated with selected doses of cannabidiol. This is particularly pertinent in the sub-population treated, all of which were not able to improve their anxiety measures using standard-of-care treatments prior to their referral to Emerald Clinics. The patient cohort was separately monitored for changes in average Brief Pain Inventory (BPI) scores - a self-reported assessment, which provides information on the intensity of pain and the degree to which pain interferes with one’s function. Data generated from the study analysis showed highly statistically significant improvements in patients’ BPI scores (p < 0.001) when treated with selected doses of cannabidiol in the target cohort of patients. For a large proportion of patients treated, chronic pain had been a primary complaint lasting more than 5 years.