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- Avecho Biotechnology (AVE) releases results for its Phase I PK study characterising the absorption of cannabidiol from its CBD soft gel capsule
- Pharmocokinetic parameters for both the 75 mg and 150 mg doses were characterised, and are suitable for use in future regulatory submissions
- Both doses were well tolerated with no adverse effects found in relation to the study medication
- An initial data pack to support testing in a range of clinical indications is now complete
- Company shares are in the green, up 15.4 per cent at 1.5 cents at 11:43 am AEDT
Avecho Biotechnology (AVE) has released results for its Phase I PK study characterising the absorption of cannabidiol from its CBD soft gel capsule.
The study’s primary objective was determining the single-dose pharmacokinetics of absorbed cannabidiol for 75 milligrams (mg) and 150 mg doses of soft-gel products.
The results highlighted the suitability for future product registration and specified that future over-the-counter products must have a maximum daily dose of 150 mg.
Sixteen volunteers participated in the study at CMAX in Adelaide, with participants receiving both doses over two weeks, with each dose proceeded by an overnight fast.
Blood samples were collected for 48 hours after each dose and assayed for CBD content.
The relationship between both doses demonstrated the absorption of the 150 mg dose almost doubled that of the 75 mg dose.
Additionally, there were minor differences with mean weak plasma concentrations for the 75 mg dose appearing two hours after dosing, whereas peak plasma concentrations for the 150 mg dose were evident after three hours.
Both doses were well tolerated, with no adverse effects found in relation to the study medication.
An initial data pack to support testing in a range of clinical indications is now complete.
Avecho CEO, Dr Paul Gavin, said the company has now assembled a thorough early phase data package.
“This data package includes formulation development and animal data; the use of highpurity, synthetic CBD; soft-gel capsule development and GMP manufacturing; ongoing stability; human Phase I pharmacokinetics; and new IP for future patent protection,” he said.
“We believe this data package will not only support ongoing regulatory and ethics approvals but also highten interest from potential partners, especially those looking to avoid two years of product development and jump straight into efficacy studies for indications of interest.”
The company says it is now focusing on the next steps to develop its CBD soft-gel product, such as utilising the product in clinical trials, including the pivotal efficacy program being designed for an insomnia related medication.
Avecho Biotechnology shares are in the green, up 15.4 per cent at 1.5 cents at 11:43 am AEDT.