Brickell Biotech closes enrollment for final U.S. clinical trial

BOULDER — Brickell Biotech Inc. (Nasdaq: BBI) said it ended enrollment for its pivotal Phase III trial for its flagship anti-underarm-sweating treatment, with plans to issue initial results this year.

The Boulder company made the announcement alongside its first-quarter earning reports, where it posted a net loss of $9 million and reported having $34.78 million in cash and equivalents on hand. It has yet to receive approval from drug regulators in the U.S. to sell any of its treatments and thus has no substantial revenues.

Its net losses increased nearly 120% from the same period last year, driven primarily by a surge of research spending from $2.66 million in the first quarter of 2020 to just more than $6 million in the first three months of 2021.

Approximately $10 million of that cash on hand came from at-the-market sales that the company announced in March in order to fund the Phase III trial.

The company said it intends to release top-line data from the trial in the fourth quarter of 2021.

Brickell’s key product is sofpironium bromide, a gel meant to stop extreme armpit sweating. The product passed primary targets in a long-term safety study that concluded last month and will likely be included in a future application to the U.S. Food and Drug Administration to allow the treatment for use in the country.

Sofpironium bromide is already available for commercial use in Japan through a licensing agreement.

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