Botanix Pharmaceuticals’ (ASX: BOT) synthetic cannabidiol-based BTX 1503 acne treatment has performed better than “leading” topically applied acne products in reducing acne lesions during a four-week trial.
Data from the phase 1b study revealed topical application of BTX 1503 had demonstrated an “excellent” safety profile and reduced the number of papules and pustules acne lesions, as well as white heads and black heads during four weeks’ treatment.
The phase 1b study was carried out at four acne research sites across Australia, with 21 subjects enrolled suffering from moderate to severe acne.
Patients were treated for 28 days and assessed for safety, tolerability and efficacy. BTX 1503 resulted in a 47% decrease in acne lesions by the end of the study. Additionally, one week after the study, on day 35, after a week of not treatment, the reduction was maintained.
“These acne study results show that BTX 1503 is potentially a very safe and highly effective therapy for the treatment of acne,” Botanix executive director Matt Callahan said.
He added the treatment had been more effective than the “leading” topically applied products currently available.
According to Botanix, non-inflammatory lesions such as white heads and black heads generally respond slower. During the study, there was about a 5% decrease in these lesions and 22.5% reduction by day 35.
In early December, Botanix reported BTX 1503 was effective against antibiotic resistant Propionibacterium acne.
Mr Callahan said he anticipated an even greater reduction in acne lesions over a longer 12-week treatment period.
“The market has suffered from a distinct lack of innovative products for more than 20 years and BTX 1503 offers an exciting new alternative to the millions of patients with acne,” Mr Callahan added.
Meanwhile University of Melbourne Professor of Dermatology Prof Rodney Sinclair said physicians and patients were continually looking out for effective new treatments and that BTX 1503 showed “great promise”.
Botanix plans to begin a phase 2 study for BTX 1503 in the June quarter after it secures FDA and pre-investigational new drug approvals.
The phase 2 study will include about 400 subjects across Australia and the US.
Shares in Botanix soared more than 34% in trade today to sit at A$0.18 by mid-afternoon.