Excessive Sweating

June 13, 2016

Dermira released results from phase III ATMOS-1 and ATMOS-2 pivotal trials for DRM04, a topical anticholinergic product candidate in development for patients with primary axillary hyperhidrosis. ATMOS-1 and ATMOS-2 were designed as identical, multicenter, randomized, double-blind, vehicle-controlled trials to assess the safety and efficacy of DRM04 at a concentration of 3.75% compared to vehicle in adolescent and adult patients (aged 9 and older). The ATMOS-1 trial enrolled 344 patients at 29 sites in the U.S. and Germany, and the ATMOS-2 trial enrolled 353 patients at 20 sites in the U.S. In ATMOS-1, the proportion of patients who achieved at least a four-point improvement in sweating severity, as measured by the Axillary Sweating Daily Diary (ASDD), was 52.8% in DRM04-treated patients, compared to 28.3% in patients who received the vehicle only (p<0.001). The average reduction in sweat production was 104.9mg in patients treated with DRM04 as compared to 91.9mg in vehicle-treated patients based on the overall dataset from the intent-to-treat population (p=0.065). The proportion of patients who achieved at least a two-grade improvement in Hyperhidrosis Disease Severity Scale (HDSS) score, a secondary endpoint, was 56.5% in patients treated with DRM04 as compared to 23.7% in patients who received the vehicle only (p<0.001). The proportion of patients with at least a 50% reduction from baseline in gravimetrically-measured sweat production, a secondary endpoint, was 72.4% in patients treated with DRM04 as compared to 53.2% in patients who received the vehicle only (p<0.001). In ATMOS-2, the proportion of patients who achieved at least a four-point improvement in sweating severity, as measured by the ASDD, was 66.1% in DRM04-treated patients, compared to 26.9% in patients who received the vehicle only (p<0.001). The average reduction in sweat production was 110.3mg in patients treated with DRM04 as compared to 92.2mg in patients who received the vehicle only (p<0.001). The proportion of patients who achieved at least a two-grade improvement in HDSS score was 61.6% in patients treated with DRM04 as compared to 27.8% in patients who received the vehicle only (p<0.001). Dermira plans to submit an NDA to the FDA for DRM04 in the second half of 2017. 

March 14, 2016

Brickell Biotech released results of a phase IIb study of BBI-4000 (sofpironium bromide) for the topical treatment of primary axillary hyperhidrosis. The multicenter, randomized, double blind, placebo-controlled study three concentrations of BBI-4000 versus vehicle (placebo gel) in 189 people with primary axillary hyperhidrosis. Study participants were randomized to apply either 5%, 10% or 15% of BBI-4000 or placebo gel to their underarms once daily for 28 days. At baseline, all subjects had Hyperhidrosis Disease Severity Scale (HDSS) scores of 3 or 4 (scale, 1-4) and =50mg/5min sweat per axilla (underarm). Results showed BBI-4000 met its primary endpoint (ITT analysis) by successfully achieving a statistically significant 2-grade improvement in the HDSS, in a dose-related fashion. At the maximum dose (15%), 38.3% of participants improved more than 2 points on HDSS at day 29 versus 12.2% with vehicle (p<0.01). Additionally, BBI-4000 achieved a statistically significant 1- and 2-grade improvement in a newly developed patient reported outcome measure, the Hyperhidrosis Disease Severity Measure Axillary (HDSM-Ax). Using this measure (ITT analysis), 44.7% achieved a greater than 2-point improvement at day 29 in the 15% treatment group versus 19.5% for vehicle (p=0.01), while 72.3% for the 15% treatment group versus 43.9% vehicle achieved a greater than 1-point improvement (p=0.01). BBI-4000 was well-tolerated at all three concentrations studied. 

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