Brickell Biotech Presents Data from Study of Sofpironium Bromide as Treatment for Excessive Underarm Sweating at AAD 2018.
M2 PHARMA-February 23, 2018-Brickell Biotech Presents Data from Study of Sofpironium Bromide as Treatment for Excessive Underarm Sweating at AAD 2018
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- Boulder, Colorado-based clinical-stage medical dermatology company Brickell Biotech, Inc. has presented positive confirmatory Phase 2b study (CL-203) results with sofpironium bromide for the topical treatment of primary axillary hyperhidrosis at the 76th American Academy of Dermatology annual meeting in San Diego, California, the company said.
The multicenter, randomized, double-blinded, vehicle-controlled Phase 2b study was designed to evaluate the safety and efficacy of three doses of sofpironium bromide delivered as a topically applied gel vs. vehicle in 227 subjects with primary axillary hyperhidrosis.
Sofpironium bromide met its primary efficacy endpoint of achieving at least a 1-point improvement in the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) score.
Statistically significant treatment responses were observed as early as Day 8 for both the 5% dose group and 15% dose group and the response was maintained throughout the treatment period.
The proportion of subject responders at the end of treatment was 70.2% for the 5% dose group and 75.9% for the 15% dose group, compared to 54.4% for the vehicle group.
Sofpironium bromide was well-tolerated at all three doses, with side effects that were transient and primarily mild to moderate in severity. The most common anticholinergic adverse event was dry mouth. No serious treatment-related adverse events were reported.
Sofpironium bromide, a new molecular entity and "soft" drug, is an anticholinergic medication that blocks the action of acetylcholine activation of sweat glands.
Soft drugs exert their action topically and are rapidly metabolised once absorbed into the blood, which allows for effective doses to be used while reducing limiting systemic side effects.
Brickell Biotech is focused on the development of innovative and differentiated therapeutics for the treatment of skin diseases. Its pipeline consists of potential therapeutics for hyperhidrosis, allergic contact dermatitis, cutaneous t-cell lymphoma, and psoriasis.
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|Date:||Feb 23, 2018|
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