New Drug Application (NDA) Ready Product

Botanix has acquired the rights for a novel product called Sofpironium Bromide, a drug in development for the treatment of primary axillary hyperhidrosis, where excessive sweating occurs beyond what is needed to maintain normal body temperature. The product has promising potential as a best-in-class solution, backed by positive results from a Phase 3 pivotal clinical program, and has already been approved in Japan and launched by Botanix’s partner Kaken Pharmaceutical Co., Ltd. (Ecclock®️ Sofpironium Bromide 5%).

Sofpironium Bromide is a new chemical entity for which Botanix is preparing to submit a New Drug Application (NDA) for US regulatory approval with the United States Food and Drug Administration (FDA) as a self-administered, once-daily, topical gel therapy in 2H 2022.

Sofpironium Bromide is an anticholinergic/antimuscarinic drug that blocks sweating at the gland by binding to the receptor and thereby blocking the sweat signal. Sofpironium Bromide is delivered to the underarms as a gel formulation using a patented applicator that allows the patient to avoid direct contact with the drug on their hands.  Approximately 85% of patients using Sofpironium Bromide gel 15% experienced a clinically meaningful improvement in their condition over the course of the Phase 3 studies.

Positive results from Phase 3 clinical studies were reported in late 2021 for Sofpironium Bromide, with all primary and secondary endpoints achieving statistical significance. More than 700 patients were enrolled in the two Phase 3 studies and approximately 300 patients participated in a 48-week safety study of Sofpironium Bromide.  There were no treatment related serious adverse events in any of the studies and adverse events were transient and mild to moderate in nature.

Positive Clinical Results

As announced in October 2021, Sofpironium Bromide gel 15% achieved all of its primary and secondary endpoints with statistical significance in a US Phase 3 clinical program.

The US Phase 3 pivotal clinical program was comprised of two pivotal clinical studies, Cardigan I and Cardigan II. The studies were multi-center, randomised, double-blinded, vehicle (placebo)-controlled, evaluating the efficacy and safety of topically applied Sofpironium Bromide gel, 15%. Each Cardigan study enrolled approximately 350 subjects nine years of age and older for the treatment of primary axillary hyperhidrosis, and subjects applied Sofpironium Bromide gel, 15% or placebo to their underarms once daily at bedtime for six consecutive weeks, with a two-week post-treatment follow-up.

Phase 3 Pivotal Clinical Program Highlights

85% of the subjects had a clinically meaningful 1-point change in the patient reported outcome measure (HDSM-Ax)

55% of patients met a more rigorous 2-point change (HDSM-Ax)

Over 60% of those subjects had both a 50% or greater reduction in sweat production and the clinically meaningful 1-grade change (HDSM-Ax)

Average reduction in sweat at week 6 was ~ 138mg

New Drug Application

Based on the results from the Phase 3 pivotal clinical program, we expect to submit a New Drug Application (NDA) for Sofpironium Bromide gel 15% to the US FDA in 2H 2022.

Our development partner, Kaken Pharmaceutical Co., Ltd., has received regulatory approval to market and sell Sofpironium Bromide gel, 5% under the brand name ECCLOCK® for the once-daily treatment of primary axillary hyperhidrosis in Japan. Kaken launched ECCLOCK® commercially in November 2020, marking the first commercialisation of Sofpironium Bromide for any indication worldwide.