AusCann Group Holdings (ASX: AC8) is speeding up plans to bring its proprietary cannabinoid-based hard-shell capsules to market, aiming to make them available for patients in Australia before the first half of next year.
The medical cannabis company today announced it has completed manufacturing and testing of the capsules and released a commercial-sized batch for clinical evaluation.
According to AusCann, its solid-fill capsule formulation is a unique presentation for cannabinoid medicines. The goal of the clinical evaluation is to provide key exposure information to inform dose selection.
“These results will build the clinical evidence supporting the unique benefits of AusCann’s capsules necessary to open a large market for the company,” AusCann chief executive officer Ido Kanyon said.
“The release of the hard-shell capsules on a commercial scale is an important milestone on the company’s accelerated road to sales,” he added.
Mr Kanyon said the company remains “on track for a timely delivery of all its strategic priorities”.
The first priority was to finalise production, testing and packaging of the capsules for a release to clinical evaluation by the end of 2019, which has now been completed on time.
According to AusCann, the tested hard-shell capsules met all applicable pre-defined criteria set by the Therapeutic Goods Administration (TGA) as well as relevant international pharmacopeial standards and the company’s own quality assurance and control procedures.
The test results confirmed: dose reliability for every capsule, assuring each dose is “true to label”; the capsules perform consistently and remain stable throughout their shelf life; and the products comply with the international quality control standards of pharmaceutical products prescribed by doctors.
Accelerated path to market
Following the positive test results, the company said it will now progress with an accelerated path to commercialisation.
“We remain focused on making AusCann’s capsules available for prescription to patients in Australia during the first half of 2020,” Mr Kanyon said.
The products will be supplied to physicians where approved under the TGA Special Access Scheme and Authorised Prescriber Scheme programs in Australia.
AusCann shares shot up 36.11% to $0.245 on today’s news by early afternoon trade.