Cannabinoid-derived therapeutic products developer, AusCann Group, announced that it has commenced the design phase for a clinical discovery trial to evaluate the company’s proprietary cannabinoid-based formulations in people with Spinal Cord Injury.
The plans follow the completion of a technical assessment completed by the Clinical Research division of Cannvalate Pty Ltd for the use of CBD:THC for symptoms associated with SCI.
In September, AusCann announced it had appointed the Cannvalate, to complete a strategic review of AusCann’s existing animal data and research assets to support the development of new cannabinoid-based drug candidates which could be fast-tracked for human registration pathways.
The scope of the assessment addressed U.S. FDA regulatory pathways, commercial feasibility, clinical trial mapping and the pathology and symptoms of people suffering from Spinal Cord Injury, which is an underdeveloped area with an addressable market size of US$6 billion.
The aim of the discovery program is to generate clinical data on the benefits of the company’s formulations, which may then be used to support a more extensive human drug development program for marketing approval via the U.S. FDA.
AusCann noted that the company’s key medical advisors have seen encouraging benefits in patients with Spinal Cord Injury after the use of the company’s Neuvis THC/CBD oral capsule’s and will play a key role in shaping the design of the discovery program.
The initial study will commence upon approval by a human research ethics committee, with an initial HREC submission expected to be made in early 2022.