SHENZHEN, China, June 30, 2026 - Artivila Biopharma, a clinical‑stage biotech company pioneering AI-driven drug discovery and development, today announced that the first patient has been dosed in its Phase 2 clinical trial of ARD-885, a first-in-class dual inhibitor targeting IRAK4 and IRAK1 for the treatment of moderate-to-severe active rheumatoid arthritis (RA).

The multicenter, randomized, double-blind, placebo-controlled Phase 2 trial is designed to evaluate the efficacy and safety of ARD-885 in patients with moderate-to-severe active RA across more than 20 clinical sites in China.

ARD-885 is the first IRAK4 and IRAK1 dual-target small molecule inhibitor to have initiated Phase 2 trial for autoimmune diseases. IRAK4 is a key player in TLR/IL-1R-mediated inflammatory signaling, while IRAK1 not only relays IRAK4 signal transduction but also has its independent roles in inflammatory responses. By inhibiting both IRAK4 and IRAK1, ARD-885 can achieve more efficacious modulation of inflammatory pathways and potentially superior clinical outcomes.

In a Phase 1 study completed in August 2025, ARD-885 demonstrated favorable safety and tolerability, with no Grade 3 adverse events (AEs) or any serious adverse events (SAEs) across all dose cohorts. It exhibited consistent linear and dose-proportional pharmacokinetics with robust systemic exposure. In accompanying PK/PD studies, ARD-885 achieved significant inhibition of pro-inflammatory biomarkers. These encouraging Phase 1 results established a solid foundation for advancing ARD-885 into the next stage of clinical development. Beyond RA, Artivila plans to expand ARD-885's therapeutic scope to include other autoimmune and inflammatory indications, such as cutaneous lupus erythematosus (CLE), systemic lupus erythematosus (SLE), atopic dermatitis (AD) etc.

About Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a chronic autoimmune disease affecting an estimated 17.6 million people worldwide, with more than 5 million patients in China alone.

Despite the availability of multiple treatment options, approximately 5% to 20% of RA patients are considered difficult-to-treat (D2T), failing to achieve adequate disease control despite receiving multiple biologics or targeted synthetic DMARDs. For patients refractory to TNF-α inhibitors—the current standard of care—treatment options remain limited, representing a substantial unmet need. Additional challenges, including cardiovascular and infection risk, systemic involvement, and management of patients with comorbidities, highlight the need for additional treatment strategies to improve efficacy.

About Artivila Biopharma

Artivila Biopharma is a clinical-stage biotech company with a diversified portfolio of therapeutic pipelines across autoimmune diseases, neurodegenerative diseases and oncology. Founded in 2018 by Dr. Zhendong Zhu and Dr. Deqiang Niu — each with over 20 years of pharmaceutical R&D experience — Artivila integrates artificial intelligence with proven drug R&D capabilities to accelerate the development of transformative medicines.

Leveraging its unique "AI + HI" (Artificial Intelligence + Human Intelligence) dual-driven model, the company combines a modular AI R&D platform with the deep scientific expertise of its core team to build, with exceptional efficiency and cost-effectiveness, a pipeline of First-in-Class (FIC) and Best-in-Class (BIC) candidates across a broad range of indications. With multiple programs among the global front-runners, Artivila is committed to delivering innovative therapies to patients worldwide.

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