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Botanix acne therapy fails to reduce inflammatory lesions in midstage study

Botanix Pharmaceuticals Ltd. will advance the acne therapy BTX 1503 into a phase 3 clinical trial despite its failure to beat placebo in a midstage study.

Trading was initially halted on the Australian Stock Exchange on the news, but upon market open on Oct. 23, the stock had fallen by half, dropping from 24 Australian cents down to 12 Australian cents.

The Australian biotech company, which focuses on the development of cannabis-based therapies, was evaluating three different doses of its acne therapy compared to once- or twice-daily doses of placebo in the phase 2 study. Patients received either 5% or 2.5% BTX 1503 daily, or a 5% dose of the drug twice daily.

After 12 weeks of treatment, all doses of BTX 1503 reduced inflammatory lesions in acne patients older than 12 years, Botanix noted in its Oct. 22 news release. The group getting a once-daily dose of 5% BTX 1503 saw the highest efficacy with an average reduction in lesions of 40.54%. But the drug did not beat placebo, which saw a 40.15% reduction in lesions.

The trial did, however, meet a secondary goal of reducing non-inflammatory lesions.

Botanix will have a phase 2 completion meeting with the U.S. Food and Drug Administration, and is planning to move the therapy on to a phase 3 clinical trial.