Botanix Pharmaceuticals (ASX:BOT) has announced the acquisition of a novel dermatology asset known as Sofpironium Bromide gel.
The company said the product has been developed to treat primary axillary hyperhidrosis – a medical condition which results in excessive underarm sweating.
The acquisition is from Brickell Biotech which developed the product through successful pivotal studies in late 2021.
Botanix president and executive chair Vince Ippolito said, “We are very excited to complete the acquisition of Sofpironium Bromide, which represents the first and only new chemical entity developed for primary axillary hyperhidrosis.
“Having demonstrated statistically significant efficacy and favourable safety in pivotal studies, we are well advanced in preparing Sofpironium Bromide for FDA approval in the second half of this year and look forward to accelerating Botanix into a commercial dermatology company much sooner than we originally expected.”
Sofpironium Bromide is a new chemical entity that is a once-daily, topically administered therapy for the treatment of primary axillary hyperhidrosis. It works by blocking sweating at the gland, by binding to the receptor and thereby blocking the sweat signal. It is delivered to the underarms as a gel formulation, using a patent-pending applicator that allows the patient to avoid direct contact with the drug on their hands.
Botanix chief medical adviser Dr Patricia Walker said, “The data demonstrates that once-daily topical Sofpironium Bromide achieved early, sustained, and significant improvements in primary axillary hyperhidrosis signs and symptoms consistent across all efficacy measures and was generally well-tolerated over six weeks of treatment.
“There is a real need for new and improved hyperhidrosis treatment options, and the results from these pivotal Phase 3 studies further support the potential for Sofpironium Bromide to become a first-line therapy of choice for patients with primary axillary hyperhidrosis.”
Botanix said it is currently working with Brickell to complete the filing of Sofpironium Bromide for FDA approval. It added it expects this to occur in the second half of 2022.