BOT – Botanix Pharmaceuticals | Aussie Stock Forums

The study achieved all the Company’s BTX 1503 program goals. Top line data indicated that BTX 1503 has an excellent safety profile and is very effective at reducing the number of inflammatory (papules and pustules) and non-inflammatory (white heads and blackheads) acne lesions after 4 weeks of treatment.

Botanix Executive Director Matt Callahan said “These acne study results show that BTX 1503 is potentially a very safe and highly effective therapy for the treatment of acne. The acne market has suffered from a distinct lack of innovative products for more than 20 years and BTX 1503 offers an exciting new alternative to the millions of patients with acne”

“We are extremely excited about the data generated from only 4 weeks of treatment. The large reduction in inflammatory acne lesions observed after this short treatment period, is better than the leading topically applied products currently available on the market. We expect to see even greater reductions in acne lesions and continued safety when treatment with BTX 1503 is extended out to 12 weeks.”

The Phase 1b open label acne study was conducted at four of the leading acne investigative sites in Australia and enrolled 21 subjects with moderate to severe acne, with 18 subjects completing the study. Subjects were treated for 28 days and then assessed for safety, tolerability, and efficacy at Day 28 and at a follow-up visit on Day 35.

Top line data indicated significant reductions in both inflammatory and non-inflammatory lesions and an improvement in patient satisfaction. On average, inflammatory lesions decreased by ~47% by Day 28 of the study. This significant reduction is greater than any other FDA approved topical acne product, for which data is available after 4 weeks of treatment.