ShengZhen, Sep 22, 2025, Artivila , a clinical stage biopharmaceutical company (“Artivila”), announced the successful completion of a Phase I clinical study of ARD-885, a novel Class 1 small molecule drug developed by the company for the treatment of autoimmune diseases in healthy subjects with excellent results. This marks another important milestone for Artivila in its innovative drug research and development endeavor.

This randomized, double-blind and placebo-controlled Phase I study included single ascending dose and multiple ascending dose to evaluate the safety, tolerability, pharmacokinetic (PK) characteristics, pharmacodynamics (PD) and food effects of ARD-885 tablets in healthy Chinese subjects. The study included eight single-dose and three multiple-dose regimens, and the last healthy subject completed the study and was discharged on August 14, 2025.

The Artivila team is excited about the results of the Phase I clinical study, which showed that ARD-885 exhibited excellent safety and tolerability in healthy subjects. No serious adverse events (SAE) occurred in any subjects during the study. PK data showed that ARD-885 had a good linear relationship between dose and exposure. PD data showed that ARD-885 significantly inhibited the release of multiple pro-inflammatory cytokines. These findings have demonstrated great potential of ARD-885 as a novel anti-inflammatory drug.

The positive Phase I clinical study results were in line with expectations and support the advancement of ARD-885 to the next stage of clinical trials. Artivila has already initiated preparations for Phase II clinical trials, with the initial indication being rheumatoid arthritis, while also actively expanding its indications to other autoimmune and inflammatory diseases. The company will accelerate the clinical development of ARD-885, striving for an early market launch to provide new and improved treatment options for patients worldwide.

About ARD-885

ARD-885 is a novel Class 1 dual-target small molecule inhibitor against IRAK4 and IRAK1 developed by Artivila. It exhibits superior in vitro and in vivo efficacy compared to similar single-target drugs and is one of the core products of Artivila. As a highly selective IRAK4 and IRAK1 dual inhibitor, ARD-885 has the potential to provide a novel treatment strategy for patients with autoimmune/inflammatory diseases such as rheumatoid arthritis and systemic lupus erythematosus.

About Artivila

Artivila is a biotechnology company focused on using artificial intelligence (AI) platforms to empower innovative pharmaceutical R&D. Its unique data- and computation-driven drug discovery platform (AI+Human Intelligence) integrates AI with cloud computing, cheminformatics, bioinformatics, drug design, and the team's extensive industry experience to significantly reduce R&D costs and shorten development cycles. The company boasts an integrated AI/CADD R&D system and an international team led by top scientists. Its R&D focuses on autoimmune diseases, neurodegenerative diseases and oncology. Artivila currently has five innovative targeted drugs in its pipeline entering preclinical/clinical stages and has filed for over 60 patents in China and globally.

Artivila has raised nearly 300 million yuan in funding, earning recognition from numerous biopharmaceutical investors and other investment funds, providing a solid foundation for the company's rapid and steady development. The company's pipeline projects and platform technologies have also garnered widespread recognition and support, and have earned numerous awards in innovation and entrepreneurship competitions, including recognition as one of the Top 50 Chinese Innovative Enterprises, the Outstanding Enterprise Award at the China Innovation and Entrepreneurship Competition,  first prize in the biopharmaceutical category at the "Longgang Double Entrepreneurship Star" Innovation and Entrepreneurship Competition, etc.

The company is also seeking various forms of BD cooperation (such as overseas license-out, co-development, etc.) to help the rapid advancement of the first pipeline and the expansion of other blockbuster pipelines, thereby enhancing the company's overall strength.

Forward-Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “extended,” “expected,” “may,” among others. These forward-looking statements are based on Artivila’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the initiation, timing, progress, activities, goals and reporting of results of any preclinical programs and clinical trials and research and development programs.