- Botanix Pharmaceuticals (BOT) has continued progressing multiple clinical programs over the September quarter
- The healthcare stock began its atopic dermatitis study trialling the BTX 1204A formula of synthetic CBD in up to 45 dogs before it moves to treat humans with the skin condition
- Botanix is also recruiting patients for a study treating papulopustular rosacea and, concurrently, is preparing to undertake a phase 2b BTX 1801 study
- BOT spent $1.9 million on operating activities — most of which was spent on research and development and it ended the quarter with about $19.6 million in cash
- Company shares are trading steady at 6.2 cents
Botanix Pharmaceuticals (BOT) progressed a number of clinical programs during the September quarter.
At the end of the quarter, the company officially commenced its BTX 1204A study which will enrol up to 45 dogs with atopic dermatitis across Australia and New Zealand.
BTX 1204A is based on a new, higher dose formulation of synthetic cannabidiol (CBD) in a novel Permetrex formulation. This formulation recently demonstrated strong efficacy in killing bacteria in the successful BTX 1801 phase 2a study.
Each canine will be treated twice daily with BTX 1204A applied topically, over 28 days.
Positive outcomes of this study will support progress towards a late-stage phase 2b clinical study in humans with atopic dermatitis, as well as provide a number of potential commercial opportunities for the company to partner with and drive licensing programs across the animal health sector.
The BTX 1702 phase 1b/2 study is a randomised, double blind, vehicle-controlled clinical study in patients with moderate to severe papulopustular rosacea.
The study began in June and is investigating the safety and tolerability of two different concentrations of BTX 1702 alongside a placebo in 120 adults over an eight-week treatment period. Ultimately, it aims to gather more data to support the company’s broader dermatology platform.
Botanix said the recruitment of patients into the study across Australia and New Zealand remains on track and is expected to be completed in mid 2022.
Additionally, the preparations for the phase 2b study of BTX 1801 are well advanced following positive data from a phase 2a study early this year.
The study was designed to kill Staphylococcus aureus and methicillin-resistant Staphylococcus aureus (MRSA) in the noses of haemodialysis patients. Killing the bacteria helps to prevent life-threatening bloodstream infections that occur when those bacteria exit the nose and enter the catheter that these patients have implanted in their chests.
Botanix is completing formulation work, finalising packaging options to enable efficient application to each nostril and undertaking animal studies to complete the data package for ethics approval. This work is expected to be completed at the start of next year and the study will begin after that.
The company spent $1.9 million on operating activities — most of which was spent on research and development. Botanix ended the quarter with about $19.6 million in cash and 10 estimated quarters left of available funding.
Shares in Botanix Pharmaceuticals were trading steady at 6.2 cents at 2:13 pm AEDT.