Item 7.01. Regulation FD Disclosure.
On June 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.
On June 12, 2020, Kaken, the Company's development partner in Japan, presented
the positive results of its Phase 3 pivotal study for sofpironium bromide at the
Late-Breaking Research Program during the American 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 U.S. Food and Drug Administration for the Company's prospective U.S. Phase 3 pivotal trials of sofpironium bromide gel, 15%. While the Kaken Phase 3 pivotal study met each of its efficacy endpoints, no inference should be drawn with respect to the efficacy outcomes of the Company's prospective U.S. Phase 3 pivotal studies due to differences in the design, patient population and product utilized in the studies.

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•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 Japan of manufacturing and marketing of sofpironium bromide gel for primary axillary hyperhidrosis based on these data. In addition to Japan, Kaken has rights to develop and commercialize sofpironium bromide in Korea, China and certain other Asian countries. Under the sublicense agreement with Kaken, the Company is due royalties and sales-based milestone payments under certain events, which events may not occur. Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

9 9 .1 Press release issued by Brickell Biotech, Inc. on June 15, 2020 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

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