Botanix Pharmaceuticals Ltd’s (ASX:BOT) shares are trading circa 31% higher intra-day at $0.17 after successfully completing a phase 1b study in patients with acne, which met all the designated endpoints.
The phase 1b acne patient study was designed to evaluate the safety, tolerability and pharmacology of the company’s lead product for acne, BTX 150.
Botanix’s 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.
Better results compared to other FDA approved topical acne products
Top line data indicated that BTX 1503 is effective at reducing the number of inflammatory and non-inflammatory acne lesions after 4 weeks of treatment.
On average, inflammatory lesions decreased by circa 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.
The study results also demonstrated that BTX 1503 was safe and well tolerated in the study. There were no serious adverse events and no subjects discontinued the study due to an adverse event.