Emyria has received ethics approval for a Phase 1 clinical trial of ultra-pure oral CBD formulation EMD-RX5 assessing its safety and bioavailability compared to Epidyolex.
The company said the dose form has the potential to support multiple TGA and FDA registration programs including in Australia as an over-the-counter (Schedule 3) CBD treatment for the symptoms of psychological distress.
Commercial-scale GMP manufacturing of EMD-RX5 is underway, ensuring sufficient quantity of material for all trials required for registration including the current Phase 1 trial and the pivotal Phase 3 trial to follow.
The trial will be conducted at Adelaide’s CMAX Clinical Research and Emyria has successfully completed a site initiation visit.
A provisional patent has also been filed for EMD-RX5, with additional proprietary cannabinoid formulations in development.
Managing director Dr Michael Winlo said: “Uniquely among cannabidiol registration programs, Emyria’s Phase 1 clinical trial will directly compare the bioavailability of EMD-RX5’s proprietary formulation to the only successfully registered and reimbursed CBD oil in the global market to date, Epidyolex.
“EMD-RX5 is a high-performing and cost-effective CBD capsule with the potential to address multiple indications. Emyria’s first registration program is aimed at developing an over-the-counter, Schedule 3 treatment targeting the symptoms of psychological distress.”
UPDATE (March 10, 2022): Emyria has now started participant recruitment, screening and consenting for the trial with first dosing expected to take place by the end of March.
Incannex has signed a licence agreement with Monash University to develop a novel anxiety treatment combining virtual reality (VR) and psychedelic medicines.
The company has an exclusive global licence for an immersive therapeutic VR environment developed by clinical research platform BrainPark, based at the university’s Turner Institute for Brain and Mental Health.
It allows Incannex to investigate the use of the VR therapy tool in combination with a psychedelic drug to develop a new treatment for severe forms of one or more anxiety disorders.
CEO and managing director Joel Latham said: “The combination of psychedelic compounds with an evidence-based VR therapy is leading-edge in the field of mental health treatments.”
The established VR treatment uses an exposure-based approach, providing triggering stimuli in a graded and controlled manner.
Alongside specialised clinical support and the administration of a psychedelic drug, Incannex said the approach may allow for the development of new skills, changes in mental and biological responses to triggering stimuli, and reductions in pathological symptoms and behaviours.
An associated research and development project funded by Incannex will be led by Turner Institute head and Incannex scientific advisory board member Dr Paul Liknaitzky and clinical neuropsychologist Professor Murat Yücel.
Meanwhile, Incannex has entered a trading halt pending preliminary results of its phase 2 clinical trial assessing its IHL-42X novel cannabinoid combination in patients with obstructive sleep apnoea.
Epsilon has entered into an exclusive partnership with The Valens Company that will see the Canadian-based manufacturer covering budgeted operational and capital expenditures at its Southport facility in return for preferential access to up to 85% of operational capacity.
Epsilon said it expects to receive A$230,000 from Valens to cover this month’s costs in the coming days. It will retain a royalty of 2.5% to 4% on sales revenue generated by Valens for medicinal cannabis products manufactured at the facility.
Epsilon will pay Valens a management fee on products manufactured for its own customers and retain the remaining margin on sales generated from non-Valens channels.
A $2 million sales target has been set during a three-month trial period starting on March 1, 2022. If this and other conditions are not met during that time, the partnership may be terminated with 30 days’ notice.
AusCann reduced losses to A$3.47 million in the six months to December 31 2021, down from $4.55m in the previous corresponding period.
Excluding non-cash costs, expenses fell by 37% to A$2.83m, a saving the firm attributed to operational efficiencies and reductions in administration, corporate, and employee expenses following its acquisition of CannPal Animal Therapeutics.
The company spent $1.65m on research and development, accounting for 58% of its total expenses for the half year. It told the ASX it remains well funded with net cash of $11.4m.