Brickell Biotech, Inc. (BBI) stock announced positive topline results from the Phase 3 pivotal clinical studies of Sofpironium Bromide Gel,15% after which it soared in the premarket. BBI stock price saw an uptrend of 27.58% to reach 0.84 a share at the time of this writing. The stock was gloomy in the previous trade and went down by 3.61% at closing. Let’s take a closer look at this stock.
Brickell Biotech, Inc is the clinical-stage biopharmaceutical stock that develops and commercializes therapeutics to treat skin diseases in the U.S. Its lead product candidate is sofpironium bromide that is intended for the treatment of patients suffering from primary axillary hyperhidrosis.
Phase 3 Pivotal Clinical Studies:
In phase 3 pivotal clinical program for sofpironium bromide gel, 15% consisted of Cardigan I and Cardigan II studies. 350 and 351 subjects participated in Cardigan I and Cardigan II studies respectively. The patients were nine-year-old and older with primary axillary hyperhidrosis. The main purpose was to evaluate the efficacy and safety of bromide gel, 15%. Sofpironium bromide gel, 15% showed well tolerance in both clinical studies. Overall, 89% of the patients completed the six weeks of treatment. The study team observed no serious adverse events during the study.
The encouraging data from the study has paved the way for bromide gel, 15% to become a potential treatment for millions with axillary hyperhidrosis. The management is now anticipating submitting the New Drug Application to FDA in the mid of 2022.
Appointment by BBI stock:
On September 1, 2021, BBI stock announced the appointment of Monica Luchi, MD, FACR, MBA as the Chief Medical Officer. Luchi is now handling the clinical development strategy and medical affairs functions of Brickell stock. Dr. Luchi has a profound experience of 20 years in the biopharmaceutical industry.
BBI stock contracted with Voronoi Inc.
Brickell also signed a definitive agreement with Voronoi Inc, which is the company developing new kinase inhibitors. According to the agreement, BBI stock had been granted the exclusive, global rights for research, development, and commercialization of therapeutics generated from the DYRK1A inhibitor platform. DYRK1A inhibitors restore the immune balance of patients with a dysregulated immune system.
The market is liking the recent announcement of positive topline results from Phase 3 of Cardigan I and Cardigan II studies. These results support the sofpironium bromide gel, 15% to become the potential treatment for patients with axillary hyperhidrosis. In a nutshell, long-term investors should keep an eye on this stock.