Emyria Ltd (ASX:EMD) has entered a master service agreement (MSA) with Clinitrials, an Australian contract research organisation, to help coordinate a pivotal phase three clinical study of the biotechnology company's proprietary cannabis medicine, EMD-RX5.
As part of Emyria's phase three clinical trial, Clinitrials will be responsible for the submission of ethics information, preparing patient recruitment materials, and conducting the clinical trial at five to six sites across Australia.
Emyria is looking forward to using real-world clinical data to provide treatments for unmet medical needs.
The data-backed, drug development company that helps pharmaceutical companies accelerate drug development provided further updates on its registration progress as well as its growing cannabinoid and MDMA (recreational drugs) analogue pipelines.
Multi-indication treatments
"Clinitrials have developed a reputation for rapid patient recruitment via the deep relationships they have established with multiple general and specialist medical practices around Australia. We are very pleased to be working closely with Clinitrials to deliver a pivotal phase three clinical trial in support of the registration of Emyria’s first proprietary and ultra-pure cannabinoid capsule, EMD-RX5," said Emyria’s managing director, Dr Michael Winlo.
"EMD-RX5 is targeting registration for the treatment of the symptoms of psychological distress - a condition affecting 15% of adults and for which there is currently no approved over-the-counter treatment. EMD-RX5 is currently completing a phase one clinical trial comparing the relative bioavailability of our first ultra-pure cannabinoid formulation to the sole registered and reimbursed CBD oil in the global market to date, Epidyolex."
Cannabidiol (CBD) oils help ease the symptoms of many common health conditions, including anxiety and neurological disorders.
Dr Winlo noted that EMD-RX5, and the next proprietary CBD dose form, EMD-RX7, could become registered treatments for multiple indications.
New CRO
Clinitrials was founded three years ago and has already conducted 15 clinical trials and operates a unique model as both a contract research organisation (CRO) and a site management organisation (SMO).
The phase three trial is expected to support the registration of EMD-RX5 as a ultra-pure, highly bioavailable CBD capsule.
In this study, the drug is being tested as an over-the-counter treatment for psychological distress symptoms.
Beyond Australia, the clinical site management organisation also manages trials in New Zealand.
MSA terms
Emyria's wholly-owned clinical service subsidiary, which is already involved in providing clinical services within Australia, will further increase recruitment by helping identify suitable patients who will then be referred for formal screening at independent sites managed by Clinitrials.
The MSA allows Emyria and Clinitrials to initiate additional clinical trials rapidly as Emyria continues to register a variety of cannabinoid-based medicines and novel MDMA derivatives that are recreational drugs.
Once the phase one study for EMD-RX5 is complete, the pivotal phase three trial will commence immediately.
There are several key conditions in the MSA to ensure that all intellectual property (IP) rights remain with the party that contributed the background IP.
All intellectual property rights in the services IP vest with Emyria.
The two-year agreement will begin on April 12, 2022, and conclude on April 12, 2024.
The agreement may be extended by Emyria in writing and either party may terminate the agreement at any time with 30 days' written notice.
As outlined in separate work orders, clinical trial fees under the agreement are determined by specific clinical trial activities.
- Amrita Ghaswalla