Brickell Biotech Announces Final Patient Completed in First US Phase 3 Pivotal Clinical Study & Patient Enrollment Completed in Second US Phase 3 Pivotal Clinical Study
Brickell Biotech, Inc. recently announced the final patient has completed the Phase 3 pivotal Cardigan I study, and that all planned patients have been enrolled in the Phase 3 pivotal Cardigan II study. Both studies are evaluating sofpironium bromide gel, 15% in patients with primary axillary (underarm) hyperhidrosis.
“This is truly an exciting time for the Brickell team, as we have now completed enrollment in both of our Phase 3 pivotal clinical studies of sofpironium bromide gel, 15%. Also, since completing enrollment in the Cardigan I study in April, the last hyperhidrosis patient enrolled has completed the study,” said Deepak Chadha, Chief Research and Development Officer of Brickell. “On behalf of Brickell, I want to take this opportunity to thank the patients and investigators who participated in the Cardigan I study, as well as those currently participating in the Cardigan II study. We remain focused on completing the Cardigan II study as planned and reporting topline results from the Phase 3 program in the fourth quarter of 2021. We look forward to sharing updates on the progress of the Phase 3 pivotal clinical studies over the coming months.”
Brickell’s U.S. Phase 3 clinical program for sofpironium bromide gel, 15% is comprised of two pivotal clinical studies, Cardigan I and Cardigan II. Each study has enrolled approximately 350 subjects nine years of age and older with primary axillary hyperhidrosis. The studies are multicenter, randomized, double-blinded, vehicle (placebo)-controlled studies evaluating the efficacy and safety of topically applied sofpironium bromide gel, 15%. Subjects will apply sofpironium bromide gel, 15% or placebo to their underarms once daily at bedtime for 6 consecutive weeks, with a 2-week post-treatment follow-up. The co-primary efficacy endpoints of both studies include the proportion of subjects achieving at least a 2-point improvement on the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) scale, a proprietary and validated patient-reported outcome measure, and change in gravimetric sweat production (GSP), each from baseline to end of treatment. Safety and tolerability assessments will be performed throughout the studies.
The company expects to announce topline results from the Cardigan I and Cardigan II clinical studies in the fourth quarter of 2021. If successful, the results from the studies are expected to form the basis of a prospective New Drug Application (NDA) in the U.S. for sofpironium bromide gel, 15% for the treatment of primary axillary hyperhidrosis. Additional details of the Cardigan I and II studies can be found on https://clinicaltrials.gov under identifiers NCT03836287 and NCT03948646, respectively.
Sofpironium bromide is Brickell’s lead investigational product candidate and is a new chemical entity that belongs to a class of medications called anticholinergics. Anticholinergics block the action of acetylcholine, a chemical that transmits signals within the nervous system that are responsible for a range of bodily functions, including activation of the sweat glands. Sofpironium bromide was retrometabolically designed. Retrometabolic drugs are intended to exert their action locally and are potentially rapidly metabolized into a less active metabolite once absorbed into the blood. Sofpironium bromide gel, 15% is currently being evaluated in a US pivotal Phase 3 clinical program for the treatment of primary axillary hyperhidrosis, and sofpironium bromide gel, 5% is approved in Japan for the same indication under the brand name ECCLOCK. Sofpironium bromide was discovered at Bodor Laboratories, Inc. by Dr. Nicholas Bodor DSc, dhc (multi), HoF, Graduate Research Professor Emeritus, University of Florida.
Hyperhidrosis is a debilitating, life-altering medical condition where a person sweats beyond what is physiologically required for thermoregulation of the body. More than 15 million people, or 4.8% of the population of the US, and 12.76% of the population in Japan, are believed to suffer from hyperhidrosis. Primary axillary (underarm) hyperhidrosis is the targeted first indication for sofpironium bromide and is the most common site of occurrence of hyperhidrosis, affecting an estimated 65% of patients with hyperhidrosis in the US. Additional information can be found on the International Hyperhidrosis Society website: https://www.sweathelp.org/.
Brickell Biotech, Inc. is a clinical-stage pharmaceutical company focused on the development of innovative and differentiated prescription therapeutics for debilitating skin diseases with a focus on its lead asset sofpironium bromide for the treatment of hyperhidrosis. Brickell’s executive management team and board of directors bring extensive experience in product development and global commercialization, having served in leadership roles at large global pharmaceutical companies and biotechs that have developed and/or launched successful products, including several that were first-in-class and/or achieved iconic status, such as Cialis, Taltz, Gemzar, Prozac, Cymbalta, and Juvederm. Brickell’s strategy is to leverage this experience to in-license, acquire, develop and commercialize innovative and differentiated pharmaceutical products that Brickell believes can be successful in the marketplace and transform lives by solving currently unmet patient needs. For more information, visit https://www.brickellbio.com.
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