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- Avecho Biotechnology (AVE) has completed the dosage form of its cannabidiol soft-gel product
- The CBD capsules will be used in Avecho’s upcoming clinical trial campaign, with production set to start at a small scale to validate the manufacturing process and analytical methods
- In parallel with this work, the company is finalising its plans to meet with the TGA to discuss its entire development program
- Avecho Biotechnology is up 13.3 per cent, trading at 1.7 cents
Avecho Biotechnology (AVE) has completed the composition and design of the dosage form of its cannabidiol soft-gel product.
The appointed manufacturer of the cannabidiol (CBD) product, Catalent, completed the capsules intended for registration with the TGA.
The CBD capsules will be used in Avecho’s upcoming clinical trial campaign, which includes phase one and a pivotal efficacy study. The finalised composition will contain 75 milligrams of CBD per soft-gel capsule.
Avecho’s leading prototype CBD oil formulation was refined at Catalent’s Florida facility in the U.S. The refinements to the product ensure the formulations are acceptable for inclusion in commercial capsule manufacturing lines, compatible with candidate gelatin capsules, and have appropriate physical and chemical stability.
Production will start at a small scale to validate the manufacturing process and analytical methods.
In parallel with this work, the company is finalising its plans to meet with the TGA to discuss its entire development program, aiming to define the clinical indication and supporting pivotal trial design.
“It cannot be emphasised enough how important it is to get the chemistry, manufacturing and controls aspect of a formulation correct,” said Avecho CEO Dr Paul Gavin.
“Positive results from this process are as critical as successful clinical trials.”
Avecho Biotechnology is up 13.3 per cent, trading at 1.7 cents at 12:00 pm AEST.