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Brickell Biotech, Inc. (BBI) is a clinical-stage pharmaceutical company dedicated to developing innovative and differentiated prescription therapeutics for debilitating skin diseases. With a primary focus on its lead asset, sofpironium bromide, Brickell is targeting the treatment of hyperhidrosis, a condition characterized by excessive sweating.
Brickell's executive management team and board of directors are seasoned professionals with significant experience in product development and global commercialization. They have previously held leadership roles at major pharmaceutical companies, contributing to the development and launch of successful products such as Cialis®, Taltz®, Gemzar®, Prozac®, Cymbalta®, and Juvederm®.
Brickell's strategic approach involves leveraging its team's vast experience to in-license, acquire, develop, and commercialize distinctive pharmaceutical products. The company aims to address unmet patient needs and bring transformative solutions to the market.
Recent updates indicate that Brickell is strengthening its cash position while exploring strategic options to maximize shareholder value. Additionally, the company plans to make cash distributions to shareholders, estimated to range between $5 million and $7 million, or $0.84 to $1.17 per share, pending shareholder approval and the filing of the certificate of dissolution.
Brickell Biotech reported that its Phase 3 Cardigan II study has surpassed 50% enrollment and that the Cardigan I study has completed enrollment. Both studies evaluate the efficacy and safety of sofpironium bromide gel, 15%, in treating primary axillary hyperhidrosis. Topline results are anticipated in Q4 2021, with potential New Drug Application submission if results are favorable. The studies aim to enroll approximately 350 subjects each, highlighting Brickell's commitment to addressing this debilitating condition affecting millions.
Brickell Biotech presented positive results from its Phase 3 ARGYLE study on sofpironium bromide gel for treating primary axillary hyperhidrosis. Over 48 weeks, the treatment was well-tolerated, with 86.1% of patients showing a one-point improvement in sweat severity. No serious adverse events were reported, and treatment-related adverse events decreased over time. Upcoming pivotal studies, Cardigan I and II, will further evaluate the 15% gel dose. Results may support a New Drug Application in the U.S. for this condition.
Brickell Biotech, Inc. (Nasdaq: BBI) announced that the results from its Phase 3 safety study of sofpironium bromide gel will be presented at the American Academy of Dermatology’s 2021 Virtual Meeting, taking place April 23-25, 2021. Sofpironium bromide is an investigational treatment for axillary hyperhidrosis, with its 5% formulation already approved in Japan. The company aims to address the significant market need, as hyperhidrosis affects around 15 million individuals in the U.S. alone.
Brickell Biotech announces the publication of results from its Phase 2b study evaluating the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax). This proprietary scale demonstrates reliable measurement of primary axillary hyperhidrosis severity, with a 1-point change signifying a clinically meaningful difference. The findings, published in the Journal of Drugs in Dermatology, support the use of HDSM-Ax in ongoing Phase 3 studies of sofpironium bromide gel, Brickell's investigational treatment for this condition.
Brickell Biotech reported strong progress in its clinical trials, specifically the U.S. pivotal Phase 3 studies for sofpironium bromide gel, achieving over 50% enrollment in the Cardigan I study. Topline results are expected in Q4 2021. Financially, cash and cash equivalents totaled $30.1 million at year-end 2020, with a net loss of $7.4 million for Q4 2020, a reduction from $10.9 million in the same period the previous year. Additionally, the commercial launch of ECCLOCK® in Japan marks significant advancement, contributing to royalty income for Brickell.
Brickell Biotech (Nasdaq: BBI) will host a KOL webinar on March 26, 2021, at 10 am EDT, focusing on the hyperhidrosis market. Dermatologists Adam Friedman, MD, and Joel L. Cohen, MD, will discuss the unmet needs and current treatment options for excessive sweating. The event will include a corporate update from CEO Robert Brown regarding Brickell's lead product, sofpironium bromide, currently in Phase 3 trials. The webinar is open to industry professionals, and registration is available on the Brickell website.
Brickell Biotech, a clinical-stage pharmaceutical company (Nasdaq: BBI), announced CEO Robert Brown's participation in two upcoming conferences: the H.C. Wainwright Global Life Sciences Conference on March 9, 2021, and the Oppenheimer 31st Annual Healthcare Conference on March 18, 2021.
Both events will be held virtually, with opportunities for one-on-one meetings with management. Webcasts of the presentations will be accessible on Brickell's website for 90 days post-event, aiming to advance their mission in treating debilitating skin diseases.
Brickell Biotech, Inc. (Nasdaq: BBI), a clinical-stage pharmaceutical company, is set to report its financial results for Q4 and full-year 2020 on March 9, 2021, post-market. The company will conduct a conference call at 4:30 PM ET to discuss these results and recent highlights. Brickell is focused on developing therapies for skin diseases, particularly highlighting its lead product, sofpironium bromide, intended for hyperhidrosis treatment. The management team boasts significant experience from prior successful product launches.
Brickell Biotech (Nasdaq: BBI) announced the ongoing commercial launch of ECCLOCK® in Japan by its partner Kaken Pharmaceutical. Efficacy and safety results from a pivotal Phase 3 study were published in the Journal of Dermatology, supporting the use of sofpironium bromide for treating primary axillary hyperhidrosis. Japan is the first country to approve this treatment. Brickell also initiated a U.S. Phase 3 clinical program for sofpironium bromide gel and expects to report topline data in Q4 2021.
Brickell Biotech has initiated the Cardigan II study, a pivotal Phase 3 clinical trial for sofpironium bromide gel, 15%, targeting primary axillary hyperhidrosis. This study follows the launch of ECCLOCK in Japan by Kaken Pharmaceutical, marking the first global commercialization of sofpironium bromide. Topline results from both the Cardigan I and II studies are expected in Q4 2021, potentially leading to a New Drug Application in the U.S. The global prevalence of hyperhidrosis affects over 15 million in the U.S. alone, highlighting a significant market opportunity.
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