Botanix Pharmaceuticals (“Botanix”), a clinical dermatology company, has announced its BTX 1702 Phase 1b/2 clinical study on papulopustular rosacea has produced clinically meaningful data.
Rosacea refers to a common skin condition which affects around 5.5% of the population, causing blushing or flushing and visible blood vessels in one’s face. Papulopustular rosacea is associated with “whitehead” pustules which typically appear on the cheeks, chin, and forehead.
The Phase 1b/2 clinical study was a randomised, double blind, vehicle-controlled study in 133 subjects, all with moderate to severe papulopustular rosacea. The two treatment arms included a 10% and a 20% BTX 1702 gel, both which were very well tolerated with no treatment reported for serious adverse events. Statistical significance was achieved with the 10% BTX 1702 gel dose in the FDA designated endpoint of reduction in inflammatory lesions and this dosage was found to be very safe and well tolerated when compared to the control gel.
The market for rosacea treatments is rapidly growing, projected to reach US$2.6 billion by 2025. There is a need for new rosacea treatments, giving BTX 1702 the potential to fulfil that demand and combine reduction in inflammatory lesions, antimicrobial effects, and general skin improvement in a single product.
Botanix medical adviser, Dr Ira Lawrence, stated that “if the efficacy continues to improve … [this] could represent the possibility of best-in-class performance with BTX 1702”.