Innocare Announces First Patient Dosed in Phase 1 Trial for Oral IL-17 Inhibitor ICP-054 (ZB021)

Innocare (09969) announced that the first participant has been dosed in the Phase 1 clinical trial for ICP-054 (ZB021), a novel oral, potential best-in-class IL-17AA/AF inhibitor. ICP-054 is a new, highly potent and selective oral IL-17AA/AF inhibitor with significant therapeutic potential in autoimmune and inflammatory diseases. It effectively blocks the signaling of both IL-17AA homodimers and IL-17AF heterodimers, thereby inhibiting the release of pro-inflammatory cytokines and chemokines to exert an anti-inflammatory effect. It also reduces excessive proliferation of skin keratinocytes and inflammatory cell infiltration, improving skin lesions and inhibiting the onset of autoimmune and inflammatory diseases. Preclinical studies have shown that ICP-054 demonstrates strong anti-inflammatory effects and a favorable safety profile both in vitro and in vivo, exhibiting high potency and excellent ADME (absorption, distribution, metabolism, and excretion) properties in vitro. The IL-17 signaling pathway has demonstrated broad application value in various rheumatological and dermatological indications. Currently, there are no oral IL-17 inhibitors approved globally or in late-stage development. The oral small-molecule nature of ICP-054 offers potential advantages over currently approved biologic IL-17 therapies in terms of dosing convenience, patient compliance, and clinical accessibility. Preclinical data for ICP-054 show promising pharmacological and safety characteristics, providing strong support for the initiation of the Phase 1 trial. In preclinical animal models, ICP-054 effectively inhibited the IL-17AA/AF signaling pathway and demonstrated anti-inflammatory activity. Furthermore, ICP-054 exhibited excellent oral bioavailability in multiple preclinical animal models, including non-human primates. All these data indicate that ICP-054 could provide a novel treatment option for autoimmune and inflammatory diseases associated with abnormal activation of the IL-17 signaling pathway. In October 2025, the company's wholly-owned U.S. subsidiary, InnoCare Pharma Inc., granted Zenas BioPharma, Inc. (Zenas; Nasdaq: ZBIO) an exclusive license to develop, manufacture, and commercialize ICP-054 (ZB021) in all regions outside Greater China and Southeast Asia. The single ascending dose (SAD) and multiple ascending dose (MAD) parts of the Phase 1 trial, conducted in collaboration with Zenas in China, aim to evaluate the safety, tolerability, and pharmacokinetics of ICP-054 (ZB021) in healthy volunteers. Upon completion of this study, the company plans to advance the clinical development of ICP-054 (ZB021) to establish proof-of-concept in the field of autoimmune diseases.