Company & Product Overview - Brickell Biotech's sofpironium bromide (SB) is a novel topical treatment for primary axillary hyperhidrosis, currently in Phase 3 clinical trials in the U S [5] - SB gel, 5% (ECCLOCK®) is approved and commercially launched in Japan by Kaken Pharmaceutical for primary axillary hyperhidrosis [5] - The company estimates a large market opportunity of over 15 million people in the U S alone suffering from hyperhidrosis [5, 9] - In Japan, the estimated market opportunity represents approximately 12.7% of the population [5, 8] Clinical Trial Results & Development - U S Phase 2b study showed statistically significant response for SB gel, 15% in Gravimetric Sweat Production (GSP) change from baseline [16] - All doses in the U S Phase 2b study demonstrated statistically significant responses for HDSM-Ax improvement [16] - In the U S Phase 2b study, subjects reporting at least one adverse event ranged from 15.8% in the vehicle group to 51.9% in the SB 15% group [18] - Kaken's Japan Phase 3 study achieved statistically significant results for primary and secondary efficacy endpoints with SB gel, 5% [25] Market & Therapeutic Context - Hyperhidrosis affects 8.8% of individuals aged 18-39 and 17.1% of those aged 12-17 in the U S [11] - Approximately 51% of U S hyperhidrosis sufferers have consulted a healthcare professional, with about 23% currently receiving treatment [11]
Fresh Tracks Therapeutics(FRTX) - 2020 Q4 - Earnings Call Presentation