Brickell Biotech Announces Initiation of U.S. Phase 3 Program Evaluating Sofpironium Bromide Gel, 15% for the Treatment of Primary Axillary Hyperhidrosis

Nachrichtenquelle: globenewswire
06.10.2020, 13:00  |  160   |   |   

Primary axillary hyperhidrosis is estimated to affect over 10 million people in the U.S.

Sofpironium bromide is a retrometabolically designed investigational new chemical entity

BOULDER, Colo., Oct. 06, 2020 (GLOBE NEWSWIRE) -- Brickell Biotech, Inc. (“Brickell”) (Nasdaq: BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, announced today the initiation of its first pivotal U.S. Phase 3 clinical study evaluating sofpironium bromide gel, 15% as a potential treatment for primary axillary (underarm) hyperhidrosis (“Cardigan I Study”).

“This continues to be an exciting time for Brickell, with initiation of our first pivotal U.S. Phase 3 study coming just on the heels of the regulatory approval in Japan of sofpironium bromide gel, 5% for the treatment of primary axillary hyperhidrosis,” commented Robert Brown, Chief Executive Officer of Brickell. “The start of the Cardigan I Study is an important step towards achieving our goal of developing a potentially best-in-class treatment to improve the lives of millions of patients suffering with primary axillary hyperhidrosis in the U.S. We look forward to providing updates on the progress of our Phase 3 program later this year, including the initiation of the second pivotal U.S. Phase 3 clinical study (Cardigan II).”

The Cardigan I Study, which is expected to enroll up to 350 subjects aged 9 years and older with primary axillary hyperhidrosis, is a multicenter, randomized, double-blinded, vehicle (placebo)-controlled Phase 3 study to evaluate the safety and efficacy of topically applied sofpironium bromide gel, 15%. Subjects will apply the investigational product once daily at bedtime to their underarms for 6 consecutive weeks, with a 2-week post-treatment follow-up. The co-primary efficacy endpoints include the proportion of subjects achieving at least a 2-point improvement on the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) scale, a proprietary and validated patient-reported outcome measure, and change in gravimetric sweat production (GSP), each from baseline to end of treatment (EOT). In addition, safety and tolerability assessments will be performed throughout the study.

Seite 1 von 4
Brickell Biotech Aktie jetzt über den Testsieger (Finanztest 11/2020) handeln, ab 0 € auf Smartbroker.de



Diesen Artikel teilen

0 Kommentare

Schreibe Deinen Kommentar

Bitte melden Sie sich an, um zu kommentieren. Anmelden | Registrieren

 

Disclaimer

Brickell Biotech Announces Initiation of U.S. Phase 3 Program Evaluating Sofpironium Bromide Gel, 15% for the Treatment of Primary Axillary Hyperhidrosis Primary axillary hyperhidrosis is estimated to affect over 10 million people in the U.S. Sofpironium bromide is a retrometabolically designed investigational new chemical entity BOULDER, Colo., Oct. 06, 2020 (GLOBE NEWSWIRE) - Brickell …

Meistgelesene Nachrichten des Autors

Titel
Titel
Titel
Titel