Brickell Biotech, Inc. (BBI) has experienced a decline of 2.08% in the premarket after BBI Announces Positive Topline Results. However, the last trading session concluded at $0.63 with a decrease of 4.86%.
BBI Announces Positive Topline Results
On 7th September 2021, BBI reported Positive Topline Results, Achieving Statistical Significance on all Primary and Secondary Endpoints. Cardigan I and Cardigan II trials reported favourable topline findings (excessive underarm sweating). Firstly, two pivotal clinical trials made up 15% of the Phase 3 pivotal clinical programme. Secondly, the Cardigan I and Cardigan II trials recruited 350 and 351 participants with primary axillary hyperhidrosis, respectively. Thirdly, the trials evaluated the effectiveness and safety of topically applied sofpironium bromide gel, 15 per cent, and were multicenter, randomised, double-blind, and vehicle (placebo)-controlled. Lastly, subjects were given either 15% sofpironium bromide gel or placebo gel to apply to their underarms.
BBI expands leadership team
On 1st September 2021, BBI announced Monica Luchi is the Chief Medical Officer. This is a newly formed position within the company. Dr Luchi will be in charge of the Company’s clinical development strategy as well as medical affairs duties in this new position. Furthermore, her extensive expertise in creating and implementing clinical strategies for new medicines will be invaluable as the company accelerates the pipeline development and expansion. BBI anticipates a number of exciting novel diagnostic development-stage opportunities as it widens the primary direction into autoimmune and inflammatory diseases.
Exclusive Rights to Phase 1-Ready DYRK1A Inhibitor Program
On 1st September 2021, BBI has signed a definitive agreement with Voronoi Inc. The company focuses on developing new kinase inhibitors. Under this, BBI will have exclusive worldwide rights to research, develop, and commercialize novel therapeutics. Moreover, these new DYRK1A inhibitors restore immunological balance in individuals who have dysregulated immune systems. Hence have a wide range of applications in autoimmune and inflammatory disorders.
Brickell’s first lead initiative is BBI-02 that has shown promising effects in preclinical models of atopic dermatitis and rheumatoid arthritis, among others. When compared to existing standard-of-care treatments like JAK inhibitors and anti-TNF biologics, BBI-02 demonstrated promising reductions in disease severity and pro-inflammatory cytokines in these animals.
