Clinical dermatology company Botanix Pharmaceuticals Ltd (ASX:BOT) has been included in the ASX All Ordinaries Index, which comprises the 500 largest companies listed on the ASX.
The inclusion comes on the back of the company’s strong performance over the last 12 months, including its Sofpironium Bromide gel, Sofdra™, which is a topical treatment for excessive underarm sweating.
Sofdra™ is expected to receive approval from the US FDA in late June, with launch preparations well underway.
“We are humbled to acknowledge the confidence investors have shown in our company, as exemplified by our inclusion in the ASX All Ordinaries Index,” Botanix CEO Howie McKibbon said.
“The generous investments made in Botanix well position us for the successful launch of Sofdra™, which is expected to follow shortly after its anticipated approval in late June 2024.”
About Sofdra™
Botanix Pharmaceuticals' primary product Sofdra™ (sofpironium bromide) gel, 15%, is a novel chemical entity designed to treat primary axillary hyperhidrosis, a condition characterised by excessive sweating not necessary for normal body temperature regulation. Botanix has submitted a New Drug Application (NDA) for Sofdra™ gel to the United States Food and Drug Administration (FDA), with approval anticipated by mid-2024.
Sofdra™ gel functions as an anticholinergic/antimuscarinic agent. It works by blocking sweat production at the glandular level by binding to the receptor responsible for triggering sweat secretion. This drug is applied to the underarms using a patented applicator that prevents contact with the hands, enhancing user convenience and hygiene.
The effectiveness of Sofdra™ gel is supported by robust data from its Phase 3 clinical trials, which demonstrated that the treatment met all primary and secondary endpoints with statistical significance.
These trials, named Cardigan 1 and Cardigan 2, were multicenter, randomised, double-blind, vehicle-controlled studies. They evaluated the efficacy and safety of Sofdra gel in reducing sweat production in subjects aged nine and older.
Each study involved about 350 participants who applied the gel to their underarms daily at bedtime over six weeks, followed by a two-week post-treatment phase.
Results from these studies showed that approximately 85% of participants experienced a clinically meaningful improvement. The long-term safety of Sofdra™ gel was also confirmed in a 48-week study involving around 300 patients, with no serious treatment-related adverse events reported. The reported side effects were transient and ranged from mild to moderate.
Sofdra™ gel has already been approved and launched in Japan under the brand name Ecclock® (Sofpironium Bromide 5%) by Botanix’s partner, Kaken Pharmaceutical Co., Ltd.