Emyria Limited (ASX:EMD) will pursue the registration of its first cannabinoid-based medicine, EMD-003, to reduce symptoms of anxiety, depression and stress, with Australia’s Therapeutic Goods Administration (TGA) in 2021.
The data-backed drug development company intends to commence the pivotal human registration study for EMD-003 in the first half of 2021, with the final evidence package scheduled for completion in the second half of 2021.
In parallel to the TGA-registration plan, Emyria will also design its EMD-003 registration studies to meet the requirements of other global regulatory bodies.
One-of-a-kind clinical data asset
Emyria’s managing director Dr Michael Winlo said: “Since our doctors are focused on getting the best outcome for every patient, we gain unique insights into the performance of a wide range of products and doses across a diverse range of patients and conditions.
“By also taking our time with every patient and using our bespoke digital health platform, which also incorporates remote monitoring, we have built a high-quality and one-of-a-kind clinical data asset.
“By analysing this data, we reveal unique insights and intellectual property that can guide and accelerate multiple drug registration programs, each one focused on producing a registered medicine addressing a major unmet need once pivotal registration clinical trials are completed.
“We’re excited to pursue the pivotal registration study of EMD-003 with the TGA in 2021 and help tackle the growing global concern of mental health and, in particular, the symptoms of anxiety, depression and stress.”
Ethical source of unique data
EMD-003 was developed following an extensive analysis of data gathered from its clinical subsidiary, Emerald Clinics where long-term, individualised care are given for unresolved patient conditions.
By tracking important clinical changes using a bespoke digital health platform, Emyria has created an ethical source of unique data covering a wide variety of patients, products and formulations.
Analysis of the data reveals unique product and dose-response insights for certain patient populations and conditions.
The development of EMD-003 shows that as Emyria’s database grows, it becomes an increasingly valuable source of high-quality clinical evidence and intellectual property with the potential to support multiple IP-backed drug registration programs.
To date, only one cannabinoid-based medicine has been formally registered with the TGA – GW Pharmaceutical PLC’s (OTCMKTS:GWPRF) (FRA:GW2A), Epidyolex – a CBD-only medicine for the “adjunctive therapy of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS)”.
All other cannabinoid-based medicines are available only via Special Access Schemes, Authorised Prescribers or clinical trials.
Clinical data to help in registration
On December 15, 2020, the TGA announced a final ruling that would allow low-dose CBD to be registered as a schedule 3 medication but stressed that all applications to register a schedule 3 low-dose CBD preparation on the ARTG would involve assessment of safety and efficacy data to support the proposed dose and indication.
While the TGA decision could allow patients to purchase registered CBD products as Pharmacist Only medications, high quality, dose-, product- and indication-specific clinical evidence is crucial for any registration effort.
Emyria is uniquely placed to utilise its large body of clinical data to assist in the registration of EMD-003 and other cannabinoid medicines.
In anticipation of the TGA ruling, Emyria conducted an in-depth analysis of its own data, published literature and patent landscape.
It has also filed unique IP, which covers the use of specific doses of CBD at or below the 150mg dose for a set of medical indications and patient cohorts.
Pivotal registration clinical trials
Emyria is now further analysing its data to refine the pivotal registration clinical trials, which are expected to begin in the first half of 2021.
A final evidence package to support registration with the TGA is expected to be completed in the second half of 2021.
Global regulatory bodies registration
In parallel to the TGA-registration plan described above, Emyria will also design its EMD-003 registration studies to meet the requirements of other global regulatory bodies.
This approach will provide the company with the ability to subsequently apply for EMD-003 pharmaceutical registration within other major markets and jurisdictions.
Rising global mental health concern
Mental health is a rising global health challenge, particularly in the last 12 months.
In the 2017-2018 National Health survey, mental health topped the list of chronic health conditions in Australia, affecting 4.8 million people, or 20.1% of all Australians.
In any one year, over 2 million Australians suffer from anxiety alone, with psychological distress, in particular, increasing in incidence.
In 2018-2019, 4.3 million Australians received mental health-related prescriptions, including over 27 million antidepressant prescriptions, the recommended first-line pharmacological treatment for anxiety.
A recent internal analysis had revealed that more than 50% of Emerald patients present with moderate to severe depression, anxiety and/or stress as measured by validated clinical assessments.
The EMD-003 registration program, if successful, has been designed to deliver a new, registered medicine for the treatment of psychological distress and symptoms of depression, anxiety and stress.