Brickell Biotech Achieves Positive Phase 2b Results for BBI-4000 for Hyperhidrosis

December 22, 2015

Brickell Biotech, Inc. shared the results of its Phase 2b study of BBI-4000 (sofpironium bromide) for the topical treatment of primary axillary hyperhidrosis, or excessive underarm sweating. The multicenter, randomized, double blind, vehicle-controlled Phase 2b study was designed to evaluate the safety, tolerability, and efficacy of three concentrations of BBI-4000 versus vehicle (placebo) in 189 subjects with primary axillary hyperhidrosis. Results from the study showed BBI-4000 met its primary endpoint by successfully achieving a statistically significant and clinically meaningful 2-grade improvement in the Hyperhidrosis Disease Severity Score (HDSS), in a dose-related fashion. Additionally, BBI-4000 achieved a statistically significant and clinically meaningful 1- and 2-grade improvement in the company’s newly developed patient reported outcome measure, i.e. Hyperhidrosis Disease Severity Measure Axillary (HDSM-Ax). BBI-4000 was well-tolerated at all three concentrations studied.

“We are extremely encouraged by these promising clinical trial results, which represent another important milestone for BBI-4000 and our company,” said Patricia Walker, MD, PhD, President and Chief Scientific Officer of Brickell. “Based upon these results, we look forward to moving BBI-4000 into Phase 3 development. Based upon BBI-4000’s favorable safety profile we remain optimistic about the prospects of developing a novel topical treatment for hyperhidrosis, a debilitating condition that affects millions of people in the United States.”

David Pariser, MD, leading expert on hyperhidrosis, founding board member of the International Hyperhidrosis Society and an advisor to Brickell said, “The results of this Phase 2b study are terrific news for the hyperhidrosis community, which has been frustrated by the lack of effective and convenient treatment options. The possibility of a new treatment alternative that is topical, well-tolerated, effective and non-invasive is truly exciting and would be welcomed amongst patients and physicians.”

In addition to Brickell’s clinical development of BBI-4000 in the United States, Kaken Pharmaceutical Co., Ltd. (“Kaken”) is planning to conduct clinical studies of the drug candidate in Japan in 2016. Earlier this year, Brickell signed an exclusive license and development agreement with Kaken for BBI-4000 in Japan and certain other Asian countries.

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