Clinical dermatology company Botanix Pharmaceuticals (ASX:BOT) has announced what it describes as positive data from its BTX 1702 Phase 1b/2 papulopustular rosacea clinical study.
The company said BTX 1702 10 per cent gel dose of the study achieved statistical significance in the FDA-designated endpoint of reduction in inflammatory lesions and also approached statistical significance for the investigator’s global assessment ‘IGA for papules and pustules’.
It said the BTX 1702 10 per cent gel dose was also found to be very safe and well tolerated when compared to Permetrex vehicle (control) gel.
“The BTX 1702 20 per cent dose was not superior to the 10 per cent dose, but was safe and well tolerated and provides a significant safety margin for the target 10 per cent dose,” said the company.
Botanix president and executive chair Vince Ippolito said, “We are very pleased with the outcomes of this Study and the statistically significant performance of the 10% BTX 1702 synthetic CBD dose against the Permetrex vehicle alone.
“Going into this Study, we wanted to push the dose of synthetic CBD to test the safety and efficacy boundaries in this serious form of rosacea and this has been successfully achieved. The outcomes show that the drug is safe at high doses, but also very effective at the lowest tested dose.”
