Zenas BioPharma Announces First Subject Dosed in Phase 1 Clinical Trial of ZB021, a Novel, Potentially Best-in-Class Oral IL-17AA/AF Inhibitor

About this update from Zenas Biopharma, Inc.

- Phase 1 trial designed to evaluate the safety, tolerability, and pharmacokinetic properties of ZB021 in healthy volunteers and to establish proof-of-concept in patients with plaque psoriasis - - Phase 1 SAD and MAD data expected by year-end 2026, with proof-of-concept data in psoriasis patients anticipated in 2027 - WALTHAM, Mass., May 13, 2026 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc. (“Zenas” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative therapies for patients living with autoimmune diseases, today announced that the first subject has been dosed in the Phase 1 trial of ZB021, a novel potentially best-in-class oral IL-17AA/AF inhibitor. “Dosing the first subject in our Phase 1 trial of ZB021 marks an important milestone for Zenas as we rapidly advance our earlier-stage pipeline and broaden our presence in autoimmune and inflammatory diseases,” said Lonnie Moulder, Founder and Chief Executive Officer of Zenas. “The IL-17 pathway is well validated across a broad range of rheumatic and dermatologic indications, yet no oral therapies directed toward this pathway are approved or in late-stage clinical development. The strength of this established mechanism may support an accelerated path toward registration-directed trials, and we expect to report initial clinical data by year-end.” The ZB021 Phase 1 trial is supported by robust preclinical data demonstrating a desirable pharmacology and toxicology profile. In addition to potent inhibition of IL-17AA/AF signaling, and anti-inflammatory activity demonstrated in animal models, excellent oral bioavailability was observed across multiple preclinical species, including non-human primates. Together, these data support the potential of ZB021 to be a differentiated oral therapy for autoimmune and inflammatory diseases associated with dysregulated IL-17 signaling. The Phase 1 study is designed to evaluate the safety, tolerability, and pharmacokinetic profile of single ascending doses (SAD) and multiple ascending doses (MAD) of ZB021 in healthy volunteers and is being conducted in partnership with InnoCare Pharma in China. These data are expected by year-end 2026. Upon completion and evaluation of the SAD and MAD study, Zenas plans to initiate a proof-of-concept (POC) trial in North America to ...

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