Dr Sud Agarwal, CEO of iNGENū CRO, an Australian CRO with specialist expertise in neuroscience, examines the recent resurgence in cannabinoid research and explains why Australia is at the epicentre.
The global landscape of cannabinoid research is experiencing a dynamic resurgence, with Australia prominently at the forefront due to its unique combination of regulatory agility, economic benefits, and advanced scientific infrastructure.
These factors collectively position Australia as a leader in the burgeoning field of cannabinoid studies, making it an attractive hub for both researchers and pharmaceutical companies worldwide.
The Australian advantage in cannabinoid research
Australia’s dominance in cannabinoid research is underpinned by several strategic advantages that streamline the path from laboratory research to clinical trials, ensuring rapid development and deployment of cannabinoid-based treatments.
1. Regulatory and economic landscape
The Australian regulatory environment is particularly conducive to cannabinoid research. The Therapeutic Goods Administration (TGA) facilitates a swift approval process for clinical trials involving cannabinoids, including rapid import permissions, ethical approvals, and trial notifications. This regulatory efficiency drastically reduces delays, enabling quicker transitions from concept to clinical evaluation.
Economically, Australia offers compelling incentives for research activities. The Research and Development Tax Incentive (RDTI) grants a 43.5% cash rebate on eligible research expenditures, providing direct financial support rather than mere tax offsets. This robust support significantly enhances the economic viability of conducting high-calibre research on Australian soil, appealing to both domestic and international enterprises.
2. Clinical research and patient recruitment
In the realm of clinical research, Australia boasts a strong network of expert Contract Research Organisations (CROs) with specialised knowledge in cannabinoid therapies. Australian clinical sites and investigators are particularly open to patient recruitment for cannabinoid trials, which is often more complex in other countries due to various cultural and regulatory barriers.
The absence of a grey market for cannabis is another critical advantage. This ensures that trial participants have not used cannabis prior to their enrollment, maintaining the integrity of clinical outcomes. This contrasts sharply with regions like the US and Canada, where widespread cannabis availability can complicate participant eligibility.
3. Societal and medical acceptance
Over seven years of legalised medical cannabis use has created a supportive and non-stigmatising environment for patients participating in clinical trials. This societal permissiveness mitigates the stigma often associated with cannabis use, facilitating easier patient recruitment and retention for clinical studies.
4. Cost efficiency and operational excellence
Conducting research in Australia is also cost effective, particularly in comparison with the US. Costs are approximately 70% less, attributed to favourable currency exchange rates, the generous RDTI, and generally lower operational costs. Furthermore, operational efficiency in Australia allows for clinical studies to start in under eight weeks, markedly faster than many other countries.
5. Patenting challenges in the US
One significant deterrent to conducting cannabinoid research in the US is the complex legal landscape surrounding cannabis. Despite medical use being legal in several states, it remains federally illegal, which poses substantial obstacles for securing patents on cannabinoid-based discoveries. It also complicates the process of obtaining international patents for discoveries made in clinical trials.
This legal ambiguity makes it challenging for researchers and companies to protect their intellectual property on a global scale, discouraging many potential sponsors from conducting their trials in the US.
Australia a premier destination for R&D
Australia’s strategic initiatives in promoting cannabinoid research have solidified its role as a global leader in the field. The combination of a favourable regulatory system, substantial economic incentives, advanced clinical research infrastructure, broad societal acceptance, and a more straightforward pathway to patenting make Australia a premier destination for pioneering cannabinoid research and development.
- iNGENū CRO manages the majority of Australia’s cannabinoid-related clinical trials. The country’s favourable research environment has fostered a variety of collaborations and projects with iNGENū CRO currently performing more than nine clinical trials where the active pharmaceutical ingredient (API) is a cannabinoid.
Current cannabinoid clinical trials in Australia with iNGENū CRO include Australian companies like InhaleRx (ASX:IRX), Argent Biopharma (ASX:RGT) and Zelira Therapeutics (ASX:ZLD) and international companies like Oxford Cannabinoid Technologies (LSE:OCT) and some larger NASDAQ-listed entities in the US.
The cannabinoid studies being conducted in Australia are a mixture of phase I and II trials, mostly targeting major central nervous system disease including chronic epileptiform diseases, multiple sclerosis, orphan pain syndromes, Rett syndrome, narcolepsy and multiple different psychiatric disorders.
