Emyria
Ethics approval has been granted to Emyria for a Phase 1 clinical trial examining the safety and bioavailability of ultra-pure oral CBD product EMD-RX5 in comparison to Epidyolex.
According to the company, the formulation could underpin multiple registration pathways with both the TGA and FDA, with one Australian approach targeting an over-the-counter (Schedule 3) product for treating psychological distress symptoms.
The company is currently operating commercial-scale GMP manufacturing for EMD-RX5 to guarantee adequate supplies for all necessary registration trials, encompassing the ongoing Phase 1 study and the subsequent pivotal Phase 3 program.
CMAX Clinical Research in Adelaide will conduct the trial, with Emyria having completed a successful site initiation visit.
The company has filed a provisional patent covering EMD-RX5 and is developing other proprietary cannabinoid products.
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): The company has commenced recruiting participants and conducting screening and consent procedures, with initial dosing anticipated by late March.
Incannex Healthcare
Incannex has entered into a licensing agreement with Monash University for developing an innovative anxiety therapy that merges virtual reality (VR) with psychedelic compounds.
Under this arrangement, Incannex holds worldwide exclusive rights to an immersive therapeutic VR platform created by BrainPark, a clinical research organization housed within the university's Turner Institute for Brain and Mental Health.
This agreement enables Incannex to explore combining the VR therapy platform with psychedelic substances to create novel treatments for severe anxiety conditions.
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 VR treatment operates on an exposure-based methodology, delivering stimuli that trigger anxiety responses in a graduated and supervised fashion.
In conjunction with clinical expertise and psychedelic medication, Incannex indicates this method could enable development of coping strategies, alter mental and physiological reactions to anxiety triggers, and diminish symptomatology.
Incannex is funding an associated research initiative directed by Dr Paul Liknaitzky, who heads the Turner Institute and sits on Incannex's scientific advisory board, alongside clinical neuropsychologist Professor Murat Yücel.
In other news, Incannex has invoked a trading halt as it awaits preliminary data from its phase 2 study evaluating IHL-42X, a novel cannabinoid formulation, in individuals with obstructive sleep apnoea.
Epsilon Healthcare
Epsilon has formed an exclusive partnership with The Valens Company, whereby the Canadian manufacturer will fund budgeted operating and capital costs at Epsilon's Southport site in exchange for preferential rights to up to 85% of facility capacity.
Epsilon anticipates receiving A$230,000 from Valens shortly to cover current-month expenses, and will receive a royalty of between 2.5% and 4% on revenue from medicinal cannabis sold by Valens that was produced at the site.
For products made for Epsilon's own clients, the company will pay Valens a management charge while keeping the additional profit on non-Valens sales.
The arrangement includes an A$2 million revenue benchmark for an initial three-month period commencing March 1, 2022, with either party able to exit with 30 days' notice should this and other performance metrics fall short.
AusCann
For the six-month period ending December 31, 2021, AusCann reported a loss of A$3.47 million, an improvement from A$4.55 million in the same period a year earlier.
When non-cash items are excluded, operating expenses declined 37% to A$2.83 million, which the company attributed to improved efficiency and cost reductions in administration, corporate overhead, and staffing resulting from its acquisition of CannPal Animal Therapeutics.
Research and development spending totaled $1.65 million, representing 58% of half-year expenses, and AusCann reported to the ASX a strong cash position of $11.4 million net.
