Brickell Biotech Inc. (NASDAQ:BBI) has dosed the first patient in the second US vital Phase 3 clinical trials (“Cardigan II study”). The study is evaluating sofpironium bromide gel, 15% in around 350 subjects with primary axillary hyperhidrosis aged above nine years.
Brickell commences Cardigan II study of sofpironium bromide gel
The phase 3 program comprises of two vital studies which are the Cardigan I and Cardigan II studies that are currently enrolling participants. Brickell expected to release top-line results from the two studies in Q4 2021. If the studies are successful, results from the studies will form the basis for a potential New Drug Application for sofpironium bromide gel, 15% in the US for primary axillary hyperhidrosis treatment.
Deepack Chadha, the company’s Chief Research and Development Officer said that they are delighted to announce the commencement o the Cardigan II study. This will be the company’s second trial in the US for its pivotal third phase clinical study of sofpironium bromide gel, 15%. Chadha said that this is an important milestone for the company and they are encouraged by the progress they have made in the Phase 3 programs especially considering the current circumstances. He added that the company is looking forward to offering enrolment updates for the cardigan studies in the coming days.
Kaken launches sofpironium bromide in Japan
Recently the company’s Japanese development partner Kaken pharmaceuticals Co. Ltd. launched ECCLOC® commercial sales in Japan for treatment of primary axillary hyperhidrosis. This is the first sofpironium bromide commercialization globally. Under its sublicense agreement with Kaken, the company will receive sales milestone payments and also tiered royalties according to the net sales in Japan. Additionally, Kaken has exclusive development and commercialization rights in China, South Korea, and other Asian countries with Brickell entitled to sales royalties based on percentage net sales in the countries.
Sofpironium bromide is a novel experimental new chemical entity under the anticholinergics class of medications. Anticholinergics block acetylcholine action which is the chemical responsible for signal transmission within the nervous system supporting bodily functions.