Brickell Biotech, Inc. announced that the first subjects were dosed in the single ascending dose (“SAD”) portion of the Company's Phase 1 clinical trial evaluating BBI-02 in healthy adult subjects and patients with atopic dermatitis (“AD”). BBI-02 is a potential first-in-class, highly selective, orally bioavailable small molecule DYRK1A inhibitor that aims to restore immune balance through modulating adaptive and innate immune responses in patients with autoimmune and inflammatory diseases. The first-in-human Phase 1 trial of BBI-02 (“BBI-02-101”) is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics (“PK”), and pharmacodynamics (“PD”) of BBI-02 capsules in both healthy adult subjects and patients with AD.

Part 1A of the study is a SAD assessment of BBI-02 or placebo in healthy adult subjects, and Part 1B of the study will be a multiple ascending dose (“MAD”) assessment of BBI-02 or placebo administered once daily for 14 days in healthy adult subjects. After completing the SAD and MAD cohorts, Brickell plans to enroll Part 2 of the study, which will compare BBI-02 to placebo in patients with moderate-to-severe AD over 28 days of dosing and will include a preliminary assessment of efficacy. Topline results from the SAD and MAD parts of the Phase 1 trial are expected to be announced by early 2023.