Item 7.01. Regulation FD Disclosure. OnJune 15, 2020 ,Brickell Biotech, Inc. (the "Company") issued a press release, which is furnished as Exhibit 99.1 to this report, announcing the results of a Phase 3 pivotal study for sofpironium bromide conducted by Kaken Pharmaceutical Co., Ltd. ("Kaken"). The information in this Item 7.01, and Exhibit 99.1 attached hereto, is being furnished and shall not be deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, regardless of any general incorporation language in such filing. Item 8.01. Other Events. OnJune 12, 2020 , Kaken, the Company's development partner inJapan , presented the positive results of its Phase 3 pivotal study for sofpironium bromide at the Late-Breaking Research Program during theAmerican Academy of Dermatology (AAD) Virtual Meeting Experience . The Phase 3 pivotal study evaluated a total of 281 Japanese subjects at 22 sites. Subjects were randomized 1:1 to apply sofpironium bromide gel, 5% ("SB") or vehicle gel (placebo) once daily to the axillae for 42 days. All subjects had Hyperhidrosis Disease Severity Scale ("HDSS") scores ? 3, Hyperhidrosis Disease Severity Measure-Axillary ("HDSM-Ax") scores ? 2 and ? 50 mg/5 min gravimetric sweat production ("GSP") in each axilla at baseline. All primary, secondary and exploratory efficacy endpoints were met and demonstrated statistically significant differences between sofpironium bromide and vehicle, with safety and tolerability, as follows: Primary Endpoint:
•Proportion of subjects whose HDSS was improved to a score of 1 or 2 at the end of treatment ("EOT") and > 50% reduction in GSP at EOT was 53.9% (SB) versus 36.4% (vehicle); p-value = 0.003
Key Secondary Endpoints:
•Proportion of subjects whose HDSS was improved to a score of 1 or 2 at the EOT was 60.3% (SB) versus 47.9% (vehicle); p=0.036
•Change in the total GSP mean value for both axillae from baseline to EOT was -157.6 mg (SB) versus -127.6 mg (vehicle); p=0.0151
•Change in the HDSM-Ax-11 score from baseline to EOT was -1.41 (SB) versus -0.93 (vehicle); p=0.001
•Proportion of subjects with ?50% reduction in the rate of GSP from baseline to EOT was 77.3% (SB) versus 66.4% (vehicle); p=0.042
Exploratory Endpoint:
•Proportion of subjects with ?2 point reduction in HDSM-Ax-7 score from baseline to EOT was 27.0% (SB) versus 11.4% (vehicle); p=.00101
Safety and Tolerability:
•Common adverse events (incidence ?5%) in SB group were nasopharyngitis (14.2%), dermatitis at the application site (8.5%), and erythema at the application site (5.7%). The severity of adverse events was predominantly mild.
•2.8% of SB-treated subjects experienced any anticholinergic-class side effects; dry mouth (1.4%), constipation (0.7%) and mydriasis (0.7%).
1 Co-primary efficacy endpoints required by the
--------------------------------------------------------------------------------
•No serious adverse events related to SB were reported in the study.
Earlier this year, Kaken announced submission of a new drug application for
approval in
(d) Exhibits.
9 9 .1 Press release issued by
--------------------------------------------------------------------------------
© Edgar Online, source