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Botanix Pharmaceuticals receives FDA green light for phase 2 Study

Fuseworks Media
Fuseworks Media

Medical dermatology company Botanix Pharmaceuticals Limited (ASX:BOT, "Botanix" or "The Company") is pleased to announce that its IND application for BTX 1503 was approved by the US Food and Drug Administration (FDA). The approval allows Botanix to commence the planned Phase 2 clinical acne trial for BTX 1503, involving over 30 dermatology clinics in the US and Australia. Botanix is now accelerating study start-up to enrol the first acne patients this quarter.

To gain FDA approval for BTX 1503, Botanix submitted a comprehensive regulatory data package on the safety and potential of BTX 1503 to treat acne, as well as the design of the planned Phase 2 clinical trial in patients with moderate to severe acne. FDA’s approval supports the quality of the BTX 1503 program which has rapidly advanced from initial formulation development to Phase 2 commencement within 24 months.

Matt Callahan, Executive Director of Botanix stated, "We are very pleased to clear this important hurdle with FDA and now have a clear and rapid path to completing the Phase 2 program in the US following the recent success of our Phase 1b study."

In Q1 CY2018, Botanix successfully completed a Phase 1b study in patients with moderate to severe acne which demonstrated that on average BTX 1503 was able to reduce inflammatory acne lesions by 47%. This reduction is greater than any other FDA approved topical acne product, for which data is available after 4 weeks of treatment. The study achieved all the BTX 1503 program goals, indicating that BTX 1503 has an excellent safety profile, is very effective at reducing the number of inflammatory and non-inflammatory acne lesions and provided an improvement in patient satisfaction.

The BTX 1503 Phase 2 clinical trial is fully funded following the Company’s successful capital raising in February 2018 and will enrol approximately 360 patients and take about 12 months to complete. Patients enrolling in the study will be treated with one of two high doses, a low dose or placebo (or vehicle) and have similar endpoints as the recently completed Phase 1b study. The Phase 2 trial is designed to deliver data that allows Botanix to explore licensing and other corporate opportunities upon its successful completion at the end of Q2 CY2019.

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