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Botanix presents BTX 1503 data at international dermatology meeting

Contributor:
Fuseworks Media
Fuseworks Media

Medical dermatology company Botanix Pharmaceuticals Limited (ASX: BOT, "Botanix" or the "Company") is pleased to announce that it will be presenting a poster summarizing the successful BTX 1503 acne Phase 1b study data, at the International Investigative Dermatology (IID) Meeting to be held 19 May in Orlando, Florida.

IID is the premier international investigative dermatology conference bringing together the European, Japanese and American investigative dermatology society’s memberships. The BTX 1503 paper outlines the significant reductions in both inflammatory and non-inflammatory lesions and the improvement in patient satisfaction outcomes from the Phase 1b acne patient study.

The improvement in inflammatory lesions seen in the BTX 1503 Phase 1b study (decrease of ~47% by Day 28, maintained at ~43% a week after finishing treatment) is greater than the response seen with any other FDA approved topical acne product, for which data is available after 4 weeks of treatment.

The poster is authored by some of the key opinion leaders who were involved in the Phase 1b study, along with Botanix’s head of clinical affairs, Mark Davis.

Botanix recently announced that its IND application for BTX 1503 has been approved by the US FDA. This approval allows Botanix to commence the planned Phase 2 clinical acne trial for BTX 1503, involving approximately 30 dermatology clinics in the US and Australia. Botanix is now accelerating study start-up to enrol the first acne patients this quarter.

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 approximately 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.

Concurrently, Botanix recently announced that it has fully enrolled the Phase 1b patient study for BTX 1204 for the treatment of atopic dermatitis (also known as ‘serious eczema’) with the data read-out expected this quarter. This second product provides a potential market opportunity even greater than the market opportunity for acne.

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