Dermatologist Botanix Pharma is a step closer to bringing a safer acne treatment to the world, announcing today it has secured Australian ethics approval for a phase 2 trial of its BTX 1503 drug.

The trial is to be covered by $15 million Botanix raised in February from 15 new institutional investors. The trial will see 360 patients enrolled from June and will be treated with either one of two high doses — a low dose of the drug or a placebo.

Clinical trials are generally divided into three phases. Phase 1 focuses on safety, Phase 2 tests for effectiveness and Phase 3 examines whether the new drug is an improvement on existing treatment.

BTX 1503 is a topically applied product in development to treat moderate-to-severe acne and utilises a synthetic cannabidiol.

Cannabidiol (or CBD) is one of the active ingredients found in cannabis. It has well-researched medicinal benefits — but unlike another cannabinoid, tetrahydrocannabinol (THC), it doesn’t get you high.

Botanix hopes the drug will produce fewer side-effects than other drugs designed to impact the skin’s oil production, including Roaccutane (also marketed as Accutane), which carries a number of side effect risks ranging from very dry skin to depression.

“We continue to demonstrate rapid progress in our clinical studies, with recent successful atopic dermatitis study results and acne study results,” Botanix director Matt Callahan told investors.

Botanix Pharma shares over the past year (ASX:BOT).
Botanix Pharma shares over the past year (ASX:BOT).

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In the March quarter, Botanix banked $145,000 in cash receipts but burned $1.07 million. The business had $14 million in the kitty at the end of the quarter, with plans to outlay $4.3 million this quarter — most of which was marked for research and development.

The company’s share price has had a stellar 12 months, tripling to 14.5c over the past year.

The market has responded well to previous clinical study results, with phase 1b study results for BTX 1503 sending Botanix’s share price from 7.2c at the start of January to 14.8c at the end of the month.

Botanix has been contacted for comment.