Brickell Biotech, Inc. (BBI) stock prices were down by a marginal 0.52% as of the market closing on June 29th, 2021, bringing the price per share down to USD$0.93 at the end of the trading day. Subsequent pre-market fluctuations saw the stock rally by 5.91%, bringing it up to USD$0.98.
Sofpironium Bromide Gel, 15%, Study
The company’s U.S Phase 3 clinical program is comprised of two pivotal studies designed to evaluate sofpironium bromide gel, 15%. Cardigan I and Cardigan II each have approximately 350 subjects enrolled, each of which is above the age of 8 and has primary axillary hyperhidrosis. The efficacy and safety of topically applied sofpironium bromide gel will be evaluated in the multicenter, randomized, double-blinded, vehicle-controlled studies, with safety and tolerability assessments being performed throughout the studies.
Details of the Study
The regimen consists of subjects applying the treatment or a placebo to their underarms once daily before sleeping at night for a period of six consecutive weeks, with a 2-week post-treatment follow up. The co-primary efficacy endpoints of both studies include the demographic of patients that exhibited at least a 2-point improvement on the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) scale, which is a proprietary and validated patient-reported outcome measure. The studies will also evaluate changes in gravimetric sweat production (GSP) from baseline to the end of treatment.
Scope of Clinical Study
Topline results from each of the Cardigan clinical studies is expected for the fourth quarter of 2021. The success of these results will form the basis of a potential NDA in the U.S for sofpironium bromide gel, 15% for the treatment of primary axillary hyperhidrosis.
Phase 1 PPH Clinical Study
June 24th, 2021 had seen the company announce that its development partner, Kaken Pharmaceutical, had initiated a Phase 1 clinical study to assess the pharmacokinetics of sofpironium bromide gel. The Study would assess the efficacy and safety of the treatment in patients with primary palmoplantar hyperhidrosis in Japan. PPH is a medical disorder that is very common, resulting in excessive sweating from the palms and soles. Primary palmar hidrosis is estimated to affect 5.33% of the Japanese population, while primary plantar hyperhidrosis is thought to affect 2.79% of the population. With no existing approved topical prescription treatments available for PPH in Japan, the study’s scope is potentially massive.
Future Outlook for BBI
Armed with a solid liquidity position, BBI is poised to capitalize on the strides made in its clinical studies, with the company pushing for the commercialization and proliferation of sofpirinium bromide gel, 15%. Current and potential investors are hopeful that management will continue to leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.
