Brickell Biotech Doses First Subject in Phase 1 Study of DYRK1A Inhibitor BBI-02

Brickell Biotech, Inc. (“Brickell” or the “Company”) (Nasdaq: BBI), a clinical-stage pharmaceutical company striving to transform patient lives by developing innovative and differentiated prescription therapeutics for the treatment of autoimmune, inflammatory, and other debilitating diseases, today 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.

“I am thrilled to see BBI-02 move into the clinic, which will expand our understanding of DYRK1A’s potential as a promising, novel mechanism in autoimmunity and inflammation,” commented Dr. Bernard Khor, MD, PhD, Principal Investigator and Assistant Member at the Benaroya Research Institute for Translational Medicine and Affiliated Assistant Professor at the University of Washington. “Since reporting DYRK1A as a potential novel target to regulate immune homeostasis, encouraging data have been generated exploring DYRK1A inhibition across several autoimmune conditions. Brickell’s trial marks an important step forward for the field, and I look forward to keeping a close eye on the progress and results from this study.”

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. Additional information on this clinical trial can be found on under identifier NCT05382819.

“We are excited to announce initiation of the BBI-02-101 study for our lead DYRK1A inhibitor candidate, BBI-02, which marks the first time a DYRK1A inhibitor intended for patients with autoimmune diseases has been administered in humans,” commented Dr. Monica Luchi, Chief Medical Officer of Brickell. “I am proud of Brickell’s efforts to quickly progress BBI-02 into the clinic following our acquisition of this program in the third quarter of last year. We look forward to building on the promising preclinical results generated to-date by evaluating the clinical safety, tolerability, PK, and PD of BBI-02 throughout this year.”

Fidn out more in the press release.

Categories: Ecosystem News