Botanix Pharmaceuticals Limited announced the successful results from its Phase 1b acne patient study, designed to evaluate the safety, tolerability and pharmacology of its lead product for acne, BTX 1503. 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 black heads) acne lesions after 4 weeks of treatment. The Phase 1b open label acne study was conducted at four of the 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 (as outlined below). Inflammatory lesions are more severe than non-inflammatory lesions and can lead to nodulo-cystic lesions (large inflamed bumps), or to severe acne scarring. Most patients seek care from a dermatologist when inflammatory acne occurs (as opposed to self-treating using an over the counter product), as it is generally more unsightly and leads to more serious long-term skin damage than non-inflammatory acne. Importantly, the study also showed that on average, patients maintained a 45% reduction in inflammatory lesions at the follow up on Day 35, after a week of no treatment with BTX 1503 at all. Non-inflammatory lesions, which traditionally are slower to respond to treatment, decreased in the patient study by 5.4% at Day 28 and showed a larger decrease of ~22.5% at Day 35 of the study. These results are in line with expectations and comparable to other approved topical products. In addition, 56% of subjects self-reported that their acne was Slightly Better" or Much Better at Day 28. 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. Based on these results and having completed a Pre-Investigational New Drug (IND) meeting with the US Food and Drug Administration (FDA) in October 2017, Botanix plans to initiate a Phase 2 study for BTX 1503 in Second Quarter CY2018. The next key milestones include Botanix filing the IND application with the FDA and being permitted to proceed to conduct the planned Phase 2 Study. The randomised, double-blind, vehicle-controlled dose ranging Phase 2 study will enrol approximately 400 subjects with moderate and severe acne, across dermatology clinics in North America and Australia.