Botanix Pharmaceuticals has today updated the market with plans for its Atopic Dermatitis (AD) clinical program. This follows important recent learnings on drug dose and formulation design of synthetic CBD in dermatitis applications, together with positive data from a new pilot study conducted in canines with AD.
Canine atopic dermatitis is clinically and immunologically similar to human AD, providing an efficient approach to inform progression of further human studies too.
A recent pilot study of Botanix’s BTX 1204A product in canines (a new higher dose formulation of synthetic CBD for atopic dermatitis, leveraging PermetrexTM), demonstrated significant reductions on average in both the Enhanced Pruritus Score (ESP) and Canine Atopic Dermatitis Extent and Severity Index (CADESI-04) scores over the 28-day treatment period.
Botanix is now advancing plans for a larger BTX 1204A proof of concept canine study in Australia, with goals to confirm and expand safety and efficacy data. Following this, the Company will pursue opportunities for partnering the product in animal health markets and progress towards a Phase 2b study for AD in humans in 1H 2022.