Brickwell Biotech Inc. (NASDAQ:BBI) has released encouraging the third phase pivotal study results from Kaken Pharmaceuticals Co. Ltd. its Japanese-based development partner.
Phase 3 Kaken study met primary and secondary endpoints
The study met all the primary as well as secondary efficacy endpoints. The company presented the results at the American Academy of Dermatology (AAD) Virtual conferences as part of the Late-Breaking Research Program. The title of the presentation was, “A Phase 3, Randomized, Double-Blinded, vehicle-controlled Study to Evaluate the Safety and Efficacy of Topically Applied Sofpironium Bromide Gel, 5% in Japanese Patients with Primary Axillary Hyperhidrosis.”
At the beginning of this year, Kaken submitted a new drug application for manufacturing and commercial approval in Japan for sofpironium bromide gel in primary axillary hyperhidrosis. The company’s Chief R&D Officer Deepak Chadha said that the company was encouraged by the positive third phase study results by Kaken as well as the submission of the Japanese New Drug Application. Chadha added that there is growing interest in the medical community globally for therapeutic alternatives for primary axillary hyperhidrosis. Therefore the positive data will offer more clinical backing for sofpironium bromide being a potentially first in class treatment for the condition.
The study enrolled 281 subjects
The pivotal third phase study evaluated 281 subjects in Japan that were randomized 1:1. The subjects applied 5% sofpironium bromide gel (SB) or the placebo vehicle gel for 42 days to the axillae. Results indicated that the subjects achieved both primary as well as secondary efficacy endpoints with statistically noteworthy differences between the vehicle and sofpironium bromide.
There were adverse effects observed in the cohort treated with sofpironium bromide, which included nasopharyngitis, erythema, and dermatitis at the site of application. Around 2.8% of the subjects experience some anticholinergic side effects that included constipation, mydriasis, and dry mouth. The adverse effects were not that severe and were only mild with no serious adverse effect shown on the study.
Besides Japan, Kaken also has rights for developing and marketing sofpironium bromide in China, Korea, and some other Asian countries.