Medicinal cannabis pharmaceutical company AusCann Group Holdings Limited (ASX: AC8) is ready to commence its first clinical evaluation of its hard-shell capsule formulation after receiving all required approvals.
AusCann CEO, Ido Kanyon, said the hard-shell capsule formulation is a unique presentation for cannabinoid medicines, and the study will provide key exposure information to inform dose selection.
AusCann intends to conduct a randomised, open-label, cross-over Phase I bioavailability study trial in healthy volunteers to evaluate the pharmacokinetics of its hard-shell capsules at two different dose strengths of balanced THC:CBD formulations.
Following participant recruitment, the study is scheduled to start on April 20, 2020, depending on any COVID-19 timing impacts.
Mr Kanyon said that concurrently with the clinical study and following interest from medical practitioners, AusCann has made the dose-controlled capsules commercially available for prescription to patients in Australia through the Therapeutic Goods Administration’s (TGA) Special Access Scheme and Authorised Prescribers.
The company has received all appropriate notifications from the TGA, commercial inventory of the hard-shell capsules was shipped to distribution partner CH2 and is now authorised for distribution in Australia.
AusCann has developed standardised cannabinoid-based formulations in a dose-controlled capsule,” Mr Kanyon said.
“The capsules have been tested in a lab setting and demonstrated to be reliable, stable and deliver a consistent controlled dose of the formulations. We are now excited to commence the clinical evaluation of the capsules to demonstrate the product’s benefits for patients.
“We are extremely pleased to have reached this milestone and that our capsules are now available for prescription.
“These results will build the clinical evidence supporting the unique benefits of AusCann’s capsules, whilst enhancing the medical acceptance of cannabinoid-based medicines for the benefit of patients in Australia.”
“At the same time, the company’s hard-shell capsule products are now available for prescribing by authorised doctors in Australia.”