AusCann Group Holdings Limited(ASX:AC8) 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 (SCI).
The programme follows the completion of a technical assessment completed by the Clinical Research division of Cannvalate Pty Ltd the use of CBD:THC for symptoms associated with SCI.
In September 2021, AusCann announced it had appointed the Clinical Research division of 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 (Food and Drug Administration) 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.
Following the completion of the assessment, AusCann has made the decision to withdraw from its previously planned investigator-led trial to redirect its resources to a research and development program which is better designed to support product registrations in targeted medical conditions.
The aim of this discovery programme is to generate clinical data on the benefits of the Company’s proprietary cannabinoid-based formulations for people suffering from symptoms associated with Spinal Cord Injury, which may then be used to support a more extensive human drug development program for marketing approval via the U.S Food and Drug Administration.
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 (HREC), with an initial HREC submission expected to be made in early 2022.