MIAMI, FL December 17, 2015 – Brickell Biotech, Inc. (“Brickell”), a clinical-stage pharmaceutical company focused on the development of innovative and differentiated therapeutics to satisfy medical needs in the global dermatology marketplace, today announced 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.
About Sofpironium Bromide
Sofpironium bromide, a new molecular entity, belongs to a class of drugs called ‘anticholinergics,’ which exert their effect by blocking the action of acetylcholine, a chemical that transmits signals within the nervous system that are responsible for a range of bodily functions, including the activation of sweat glands. Soft-anticholinergics, such as sofpironium bromide, exert their action topically and are rapidly metabolized into a considerably less active metabolite when they reach the blood system, thus potentially allowing for effective doses to be used while reducing the limiting systemic side effects associated with other drugs in this class. Sofpironium bromide was originally developed at Bodor Laboratories, Inc. by Dr. Nicholas Bodor, an internationally recognized leader in retrometabolic drug design approaches.
Hyperhidrosis is a medical condition that affects an estimated 8 million people – or 3% of the population – in the United States. It can affect the axillae (underarms), palms of hands, soles of feet, face and other areas. Hyperhidrosis can frequently and significantly impair social, occupational and emotional well-being.
About Brickell Biotech
Brickell Biotech, Inc. is a clinical-stage pharmaceutical company focused on the development of innovative and differentiated therapeutics for the treatment of skin diseases. Its pipeline consists of five product candidates, including potential novel therapeutics for hyperhidrosis (excessive sweating), atopic dermatitis, allergic contact dermatitis, acne and psoriasis. Brickell’s management team and board of directors have extensive experience in product development, having served in leadership roles at several pharmaceutical and successful start-up companies. Its strategy is to leverage this experience to in-license, acquire, develop and commercialize products that Brickell believes can be successful in the dermatology marketplace. For more information, visit www.brickellbio.com.
About Kaken Pharmaceutical Co., Ltd.
Kaken (Tokyo Stock Exchange: 4521) is a Japanese specialty pharmaceutical company with a strong presence in the dermatology (antifungals) and orthopedics markets. The company’s primary areas of research and development focus include inflammation, immunology (dermatitis, rheumatoid arthritis and osteoarthritis), pain and antifungals.
This press release contains forward-looking statements that involve substantial risks and uncertainties. Words such as “believes” and “planning” or similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to the inherent uncertainties in predicting future results and conditions, many of which are beyond the control of Brickell. Brickell undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.
Patricia L. Bank