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

– BBI-02 is a potential first-in-class, oral DYRK1A inhibitor with strong preclinical validation and broad potential to treat debilitating autoimmune and inflammatory diseases –

– Topline results from the SAD and MAD parts of the Phase 1 study expected to be announced by early 2023 –

BOULDER, Colo., May 19, 2022 (GLOBE NEWSWIRE) -- 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.”

About BBI-02

BBI-02 is a highly selective and orally bioavailable DYRK1A (dual specificity tyrosine-phosphorylation-regulated kinase 1A) inhibitor that has demonstrated promising results in various preclinical models, including atopic dermatitis and rheumatoid arthritis. In these models, BBI-02 showed encouraging decreases in disease severity and reduction of pro-inflammatory cytokines compared to current standard-of-care agents, such as Janus kinase (JAK) inhibitors and anti-tumor necrosis factor (TNF) biologics. Notably, many current therapies for autoimmune disorders are broadly immunosuppressant, which may lead to severe side effects, such as increased infection risk. Preclinical data have shown BBI-02 to drive regulatory T-cell differentiation while dampening pro-inflammatory TH17 cells and myeloid differentiation primary response 88 (“MyD88”)/IRAK4-related signaling pathways. Regulatory T-cells serve to maintain tolerance and keep the autoreactive, pro-inflammatory T-cells in check, thus inhibiting autoimmune disease and limiting chronic inflammation. The MyD88 protein is normally spliced into a long form and a short form. DYRK1A inhibition shifts the balance to produce more MyD88 short form, which leads to IRAK4, a protein kinase involved in signaling immune responses from toll-like receptors, not being phosphorylated and so appears to deactivate downstream cascades of certain pro-inflammatory cytokines. Based on current understanding, this inhibition of the release of excess cytokines can be achieved by re-establishing the role of MyD88 short form as a negative regulator of this pathway. Unlike many existing therapies for autoimmune diseases, as well as those currently being investigated, BBI-02 may have the ability to target both the adaptive and innate immune imbalance simultaneously, potentially resulting in, or substantially achieving, restoration of immune homeostasis that, if proven, would represent a paradigm shift in the treatment of certain autoimmune and inflammatory diseases.

About Brickell

Brickell Biotech, Inc. is 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. Brickell’s pipeline consists of several development-stage candidates and a cutting-edge platform with broad potential in autoimmune and inflammatory disorders. Brickell’s executive management team and board of directors bring extensive experience in product development and global commercialization, having served in leadership roles at large global pharmaceutical companies and biotechs that have developed and/or launched successful products, including several that were first-in-class and/or achieved iconic status, such as Cialis®, Taltz®, Gemzar®, Prozac®, Cymbalta®, and Juvederm®. Brickell’s strategy is to leverage this experience to in-license, acquire, develop, and commercialize innovative pharmaceutical products that Brickell believes can meaningfully benefit patients who are suffering from chronic, debilitating diseases that are underserved by available therapies. For more information, visit

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Brickell Investor Contact:
Dan Ferry
LifeSci Advisors
(617) 430-7576