Innovent Biologics, Inc. , a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major disease areas, announced that the first participant has been successfully dosed in a Phase 1 clinical trial of IBI3011, an anti-human Interleukin 1 receptor accessory protein (IL-1RAP) monoclonal antibody developed by Innovent.

This study is a single ascending dose (SAD) study to evaluate the safety, tolerability, and pharmacokinetics of IBI3011 for the first-in-human administration, so as to support the subsequent clinical development of IBI3011. A total of 40 healthy volunteers and 24 patients with gout flares are planned to be enrolled.

With economic development and rising living standards, the number of gout patients in China is increasing. By 2019, the estimated number of patients had exceeded 3 million.^[1],[2] When serum uric acid rises above its saturation point, urate crystals can deposit in joints, triggering local inflammation and tissue damage and causing gout flares.^[3] Recurrent flares can lead to joint destruction and functional impairment, limiting patients' social roles and seriously reducing quality of life.

At present, first-line pharmacologic treatments for gout flare mainly consist of nonsteroidal anti-inflammatory drugs and colchicine, to which certain patients have contraindications or cannot tolerate, lacking targeted therapies. Second-line therapies as glucocorticoids are also associated with numerous adverse effects. In addition, only one IL‑1β–targeted agent has been approved in China for the treatment of gout flare, and there remains a large unmet need in clinical practice.

IL-1RAP, a member of the IL-1 family, serves as a co-receptor that forms receptor complexes with IL-1R1, ST2, and IL-36R and mediates downstream signaling pathways triggered by IL1α/β, IL33 and IL36, respectively. These cytokines are implicated in a broad spectrum of autoimmune and inflammatory diseases including acute gouty arthritis, hidradenitis suppurativa, etc. Compared with anti‑IL‑1β antibodies, targeting IL‑1RAP can simultaneously block multiple IL‑1 family inflammatory pathways, with the potential to rapidly control inflammation, relieve gout symptoms, and enable earlier initiation of urate‑lowering therapy.

IBI3011 is the first anti-IL‑1RAP monoclonal antibody in China aimed to address inflammatory and autoimmune diseases. Preclinical data show that IBI3011 can significantly suppress gout flares in models of acute gouty arthritis, highlighting its clinical potential for the treatment of gout flares. In this therapeutic area, Innovent plans to initiate a Phase 3 trial of IBI128 (tigulixostat) in gout patients with hyperuricemia. Previously, the Phase 2 clinical results of IBI128 were presented at APLAR 2025 showing strong efficacy in reducing serum uric acid in patients with gout. On top of that, IBI3011 has the potential to further suppress gout flares, complementing tigulixostat's uric acid-lowering effect to provide a more comprehensive treatment approach for patients with hyperuricemia and gout. Additionally, Mazdutide could also provide the benefit of reducing blood uric acid in the obesity population. Together, these assets provide more personalized treatment options for patients with gout and hyperuricemia. With IBI3011 now entering the clinical stage, Innovent will further strengthen its pipeline in metabolic and autoimmune diseases.

Dr. Lei Qian, Chief R&D Officer of General Biomedicine of Innovent Biologics, stated, "I am very pleased that the first participant has been dosed in the Phase 1 clinical study of IBI3011, and I look forward to its result supporting the development of treatments for gout flares and other indications. Innovent Biologics' general biomedicine pipeline reflects a well-structured, echeloned and matrix-like strategy across the fields of cardiovascular and metabolic diseases (CVM), autoimmune diseases, and ophthalmology. For gout, a metabolic and immune-related condition, IB3011 complements the promising Phase 2 clinical results of IBI128 (tigulixostat), which demonstrated excellent efficacy in targeting XOI and is now advancing to Phase 3. By focusing on next-generation global innovations, Innovent is accelerating the development of high-potential molecules and the synergy of these products is expected to bring more innovative therapies that improve the quality of life to patients around the world."