Benzinga | Apr 15, 2021 08:12AM EDT

Brickell Biotech Announces Publication of its HDSM-Ax Patient Reported Outcome Scale Validation Results in the Journal of Drugs in Dermatology

Brickell Biotech, Inc. ("Brickell" or the "Company") (NASDAQ:BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, today announced that results from a Phase 2b study evaluating the use of Hyperhidrosis Disease Severity Measure-Axillary(c) (HDSM-Ax), Brickell's proprietary patient reported outcome (PRO) scale, to measure primary axillary hyperhidrosis (AHH) severity were published in the peer-reviewed Journal of Drugs in Dermatology. The article, entitled "Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax): Evaluation of Measurement Performance," can be accessed online here.

The psychometric analyses conclude that HDSM-Ax is a well-defined and reliable measure of primary AHH severity that is expected to improve the assessment of axillary hyperhidrosis treatment effects compared to pre-existing scales, such as the Hyperhidrosis Disease Severity Scale (HDSS). The analyses determine that a 1-point change in HDSM-Ax severity score (on a 0-4 scale) represents a clinically meaningful change in AHH severity.

"We are pleased to publish the evaluation of measurement performance results of the HDSM-Ax scale, which further confirm its ability to more reliably, consistently, and effectively assess the severity of primary AHH as compared to previously used PROs," said Deepak Chadha, M.S. M.B.A., Brickell's Chief Research & Development Officer. "We developed and validated this PRO scale to assess the efficacy of sofpironium bromide gel in reducing sweating severity in patients with primary AHH. The results of the published study demonstrate that the HDSM-Ax is a robust, validated and fit-for-purpose PRO measure of AHH severity. Furthermore, the HDSM-Ax scale forms the basis for one of the co-primary efficacy endpoints in our ongoing U.S. Phase 3 pivotal clinical studies of sofpironium bromide gel for the treatment of primary AHH."