Avecho
Avecho has secured ethics approval to proceed with a phase III clinical trial as the company pursues over-the-counter registration for a CBD product.
The randomised, placebo-controlled study will assess the effectiveness of its TPM soft-gel capsule in 540 insomnia patients.
The trial will be conducted across 10 Australian sites, among them the Monash Medical Centre in Melbourne.
Participants will be divided into three treatment groups and given CBD doses of either 75mg or 150mg, or a placebo, across an eight-week treatment period.
Avecho chief executive Dr Paul Gavin said: “Everything we have learnt over the last 15 years of drug development has gone into this product and this study. It’s a watershed moment for any biotechnology company and its investors to commence a phase III trial.”
Separately, Avecho has entered a development agreement with consumer packaged goods company Perrigo to develop a topical ibuprofen gel enhanced with its proprietary TPM formulation for the US market.
Perrigo plans to run a clinical trial for a pain-related indication using the gel in 2023. If results are positive, the parties would enter a licensing agreement and continue developing the product toward US Food and Drug Administration (FDA) registration.
Perrigo's brand portfolio includes Herron, Nicotinell and OsteoEze. The company's global range of self-care products generated net sales exceeding US$4 billion in 2021.
Research by Avecho has demonstrated that ibuprofen gels formulated with TPM can boost transdermal absorption by approximately 200% compared with commercially available topical ibuprofen products such as Nurofen, Fenbid, and Ibuleve.
Gavin said: “We have previous experience developing topical diclofenac for clinical trials and commercialisation, and look forward to including these learnings in the new ibuprofen product.”
Perrigo executive vice-president and president, consumer self-care Americas James E. Dillard III added: “TPM has been in our sights for some time, having already demonstrated effective performance in other topical pain products.”
Levin Health
AFL and NRL premiership-winning coaches Chris Scott and Trent Robinson have become the newest sports figures to join Levin Health as the company works to challenge the stigma surrounding medicinal cannabis.
Sporting and business personalities at the sports science company include Adam Gilchrist, Andrew Johns, Lauren Jackson, Damien Oliver, Alastair Clarkson, Damien Hardwick, James Brayshaw and John Longmire.
Scott said he invested in Levin “after becoming interested in the medicinal cannabis sector and what the findings could mean for professional athletes”.
He added: “[Basketball Hall of Famer] Lauren Jackson’s circumstance intrigued me and I’m interested to learn more about what implications her experience will have for athletes in the future.”
CEO Mark Brayshaw said: “Levin Health continues to investigate the efficacy of medicinal cannabis products for the treatment of pain, mental health disorders and sport-related ailments and we are heartened by the sheer volume of support we continue to receive from well-known athletes and coaches.”
“[It] will help to reduce stigma around medicinal cannabis and help our mission to improve people’s quality of life through our world-leading clinical studies,” he added.
Cannatrek
Cannatrek has settled the infringement notices issued by the TGA over alleged advertising breaches in September. The company was fined A$293,040 across 22 alleged infringements.
At the same time, Little Green Pharma was handed a $372,960 penalty for 28 alleged infringements, while MGC Pharmaceuticals faced a $306,360 fine for 23 alleged breaches. The regulator confirmed both fines remain outstanding.
Releaf Group
Releaf Group is rolling out its dispensary franchise chain across Thailand through a network of traditional Thai doctors.
The Bangkok-based subsidiary will initially function as a master franchise led by two Releaf and four local directors.
The company also plans to establish the International College of Cannabinoid Medicine and open a chain of cafes as medicinal cannabis consumption lounges in partnership with local operators.
Founder and CEO Gary Mackenzie said the Thai market has developed rapidly since decriminalisation in June.
The University of Thai Chamber of Commerce forecasts the combined medicinal cannabis and hemp market will reach A$1.8 billion by 2025.
Bod Science
Bod Science has received a A$1.51 million research and development (R&D) tax incentive rebate for FY22.
The rebate covers eligible R&D activity carried out by Bod during the period, spanning three programs in phase I and II trials and eight at the pre-clinical stage.
The company said the rebate reflects its ongoing dedication to drug development and product innovation, including a current clinical trial of a Schedule 3 (pharmacist only) CBD medicine exclusively licensed under a five-year supply agreement with Arrotex Pharmaceuticals.
CEO Jo Patterson added: “Bod continues to prioritise strategic investment in rigorous scientific research and development. This substantial R&D tax rebate is reflective of Bod’s commitment to, and strong track record of, partnerships with leaders in R&D.”
