Bod Australia has entered into an agreement with the Woolcock Institute of Medical Research for a Schedule 3 trial of a new CBD insomnia treatment.
The phase IIB clinical trial will test the efficacy of the formulation on insomnia symptoms at 50mg and 100mg daily doses in approximately 200 adults aged 18 to 65. It will last 12 weeks in total.
Bod said the initiative is a crucial step in launching an over-the-counter, pharmacist-only product in Australia, unlocking a market “valued at A$250 million”. It added the unregulated market could be worth around $3.5 billion.
CEO Jo Patterson said the company is “confident that the results of the completed clinical trial will provide the required data to commercialise an over-the-counter Schedule 3 CBD product for Australian consumers”.
She added: “With Bod’s existing distribution networks, established partnership with H&H… and a rapidly developing market for Schedule 3 products with fewer side effects than existing offerings, the successful completion of this study will launch major opportunities for the company.”
Zelira Therapeutics has signed an exclusive five-year deal with German distributor Adjupharm GmbH, giving it a first foothold in Europe.
The agreement sees Zelira expand its cannabis interests outside of Australia and the US with minimum order quantities of more than A$4 million, and $98,000 guaranteed in year one.
Adjupharm has first rights to distribute Zelira’s Rx products in Germany, including its Zenivol insomnia treatment, and to negotiate other European markets.
Zelira Therapeutics managing director Dr Oludare Odumosu said: “Today is a landmark day for Zelira, with the expansion into Germany being a key growth milestone for our company.
“This is the first distribution agreement for one of Zelira’s Rx products outside of the US and Australia, and further validates the pharmaceutical quality of our Australian production capabilities, and the safety and efficacy of our clinically validated, cannabinoid-based medicines.”
Creso Pharma has launched a new e-commerce channel to host the company’s sports, health and wellness range Cannadol under new sub brand ‘Born to move’.
Initially targeting Swiss consumers, Creso will look to extend across Europe as part of its direct-to-consumer sales strategy.
The company is rolling out a complimentary marketing campaign to build awareness and distribution of the range, using direct mail outs and social media to target consumers and entering into discussions with Swiss pharmacies, other retailers and sports clubs.
Head of international operations director Jorge Wernli said: “We can now directly target consumers and unlock another potential revenue stream and addressable market. This represents a key strategic milestone in broadening our global footprint, as well as our presence in sports and recreational markets.
“We will continue to pursue growth opportunities across Europe and can now focus on both business-to-business and direct-to-consumer paths.”
The company is also preparing to launch into Poland after securing the first purchase order for its hemp-powered animal product, Anibidiol, from local partner Polvet.
Meanwhile, Creso subsidiary Halucenex Life Sciences has announced a research collaboration with Canada’s Acadia University to develop gel capsules containing psilocybin and CBD as a vehicle for drug delivery.
Under the agreement, the pair will develop a product based on nanoemulsion technology, with a quick release effect, good bioavailability and rapid onset.
Emyria has appointed consultant psychiatrist Dr Jeremy Tannenbaum to its clinical advisory to help advance the firm’s psychedelic-assisted research and related drug-development programs.
Dr Tannenbaum’s interests and training covers the interface between psychiatry and pain medicine as well as the emerging use of psychedelic-assisted psychotherapy and other potential uses of psychedelics.
At the completion of further training, he will be one of only a small number of specialist medical practitioners in Australia to hold dual qualifications in both psychiatry and pain medicine.
Emyria managing director Dr Michael Winlo said: “Dr Tannenbaum has a unique combination of specialist training and research experience covering psychiatry, pain medicine and the use of psychedelic-assisted therapy to address major mental health concerns.”
He added Dr Tannenbaum’s expertise “can greatly advance Emyria’s MDMA-assisted psychotherapy trials for Post-Traumatic Stress Disorder, our MDMA analogue discovery and screening program, and also support [us in evaluating] the use of cannabinoid and other novel therapeutic approaches to address the biopsychosocial aspects of complex pain management.”
Meanwhile, the company said it has now completed preliminary analysis of over half of its MDMA analogue library, developed in conjunction with the University of Western Australia.
AusCann has appointed Cannvalate to complete a strategic review of its existing animal data and research assets to support the development of new cannabinoid-based drug candidates for human registration pathways.
The indications being explored — traumatic injury and neurological disorders — have an initial addressable market of more than US$2 billion globally.
The assessment will address US Food and Drug Administration (FDA) regulatory pathways, commercial feasibility, clinical trial mapping and pathology and symptoms for the target indications.
It will also include a review of AusCann’s CPAT-01 canine investigational formulation and existing animal safety, toxicology, pharmacokinetic and biomarker data which may be used to accelerate the development of a human cannabinoid-based drug candidate for FDA registration.
Canadian-based firm Allied Corp has received approval for a second import permit to export CBD isolate to Australia from its Colombian facility.
Allied (through its local partner) has also submitted its first import permit for dried cannabis flower to the Australian Department of Health after Colombian president Iván Duque Márquez approved flower exportation from the country to international medicinal cannabis markets.
Allied Corp CEO and chairman Calum Hughes said: “Australia is clearly a market that is ready for Allied’s product.”