Brickell Biotech Inc. (NASDAQ: BBI) has announced Q3 2021 financial results and also offered a corporate update about its development programs.
Positive topline results were reported during the quarter from two Phase 3 pivotal clinical trials of sofpironium bromide gel, 15% in the United States. Each study involved around 350 patients with primary axillary hyperhidrosis aged nine years and older. All primary and secondary efficacy endpoints in both studies were statistically significant, and data showed that sofpironium bromide gel, 15%, was generally well tolerated. As a result, the company anticipates submitting an NDA for sofpironium gel, 15% by mind 2022.
Positive Phase 3 sofpironium bromide gel, 15% study results
CEO Robert Brown commented, “ This has been an exciting period for Brickell, as we announced positive data from our Phase 3 pivotal clinical studies of sofpironium bromide gel, 15% and expanded our pipeline with the acquisition of a Phase 1-ready DYRK1A inhibitor and cutting-edge platform with broad potential in autoimmune and inflammatory disorders. We look to build on this momentum by focusing on several near-term clinical, regulatory, and operational milestones that we believe can drive our growth.”
Brown added, “We were pleased to announce last month that the Phase 3 Cardigan I and Cardigan II studies of sofpironium bromide gel, 15% in patients with primary axillary hyperhidrosis, or excessive underarm sweating, achieved statistical significance on all primary and secondary efficacy endpoints. Based on the positive results from these studies, we expect to submit an NDA for sofpironium bromide gel, 15% to the FDA in mid-2022. As we plan the commercial strategy for sofpironium bromide gel, 15%, if approved, we are evaluating all available options to maximize commercial product success and long-term value for the company.”
Brickell Biotech acquired rights to develop and market DYRK1A therapeutics
The company obtains exclusive research, development, and commercialization rights for novel therapeutics for the DYRK1A inhibitor platform. The acquisition includes DYRK1A inhibitors BBI-02 and BBI-03.
In Q3 2021, the company had revenue of $0.1 million realized as royalty revenue from the sale of ECCLOCK sales in Japan.
