Med-Fine Family | KeHui Pharma's Class 1 New Drug ARD-885 Successfully Completes First-in-Human Dosing in Phase I Clinical Trial
Artivila
Innovative Drug Developer
Recently, Artivila announced that its chemical small molecule Class 1 new drug ARD-885 for the treatment of rheumatoid arthritis (RA) has successfully completed the first two dose groups of the single ascending dose (SAD) stage of Phase I clinical trials at the Second Affiliated Hospital of Anhui Medical University. The post-dosing clinical observation and pharmacokinetic (PK) testing have also been completed. During the follow-up period, no serious adverse events occurred in any of the subjects, demonstrating good safety. PK data from the first two dose groups showed that ARD-885 exhibited favorable exposure and a dose-linear relationship in humans.
This study is a Phase I clinical trial with a randomized, double-blind, placebo-controlled design, involving single and multiple ascending doses. It aims to evaluate the safety, tolerability, pharmacokinetic profile, and food effect of ARD-885 tablets in healthy Chinese subjects and patients with rheumatoid arthritis. On December 13, 2024, Artivila and its leading CRO partner convened at the Second Affiliated Hospital of Anhui Medical University to successfully hold the kick-off meeting for the Phase I clinical trial of the novel drug ARD-885, officially launching the project. The completion of the clinical trial initiation and the dosing of the first subject for ARD-885 occurred just over a month after Artivila Biopharma first obtained the IND approval from the National Medical Products Administration (NMPA), significantly faster than the average start-up time for new drug clinical trials. This achievement fully demonstrates the robust communication and collaboration capabilities as well as the efficient and pragmatic work ethic between the company’s clinical development team and the clinical research center.
The successful completion of the first batch of subject dosing marks an important milestone for Artivila's R&D pipeline. Artivila looks forward to its innovative drug ARD-885 benefiting rheumatoid arthritis patients in and outside China as soon as possible, under the trust and support of patients, researchers, collaborators, and investors.
About ARD-885
ARD-885 is a novel dual-target inhibitor developed by Artivila, targeting both IRAK4 and IRAK1. Its efficacy in vitro and in vivo surpasses that of similar single-target drugs, making it one of Artivila's core products. As the first small-molecule dual-target autoimmune drug simultaneously targeting IRAK4 and IRAK1, ARD-885 has the potential to offer a new therapeutic strategy for patients with rheumatoid arthritis. Preclinical efficacy data show that ARD-885 significantly improves clinical symptoms of arthritis in rats, reduces arthritis clinical scores, decreases paw swelling volume, and demonstrates dose-dependent improvement in joint histopathological damage. Preclinical pharmacokinetic and toxicology studies indicate that ARD-885 exhibits favorable pharmacokinetics and safety. In addition to rheumatoid arthritis, ARD-885 can also expand its indications to other autoimmune diseases and holds promise for treating malignant tumors, offering broad prospects for clinical development.
About Artivila
Artivila is a new drug research and development company based on an AI-powered innovative drug platform. Its unique data- and computation-driven drug discovery platform (AI+HI) integrates artificial intelligence, cloud computing, cheminformatics, bioinformatics, drug design, and the team's extensive industry experience, significantly reducing R&D costs and shortening the R&D cycle. The company has an integrated AI/CADD R&D system and a top-tier team of scientists, with research primarily focused on neurodegenerative diseases, oncology, and autoimmune diseases. Artivila currently has five targeted innovative drugs in its pipeline that have reached the preclinical stage, and it has filed nearly 30 patent applications for inventions in China and globally.
Since its establishment, Artivila has completed multiple rounds of financing, gaining recognition from numerous biopharmaceutical professional investors and comprehensive funds, providing a solid guarantee for the company's rapid and steady development. The company's research projects and platform technologies have also received recognition and support from various parties and have won awards in innovation and entrepreneurship competitions multiple times, including the first prize in the biopharmaceutical category of the "Longgang Dual Innovation Star" competition, the Excellent Enterprise Award of the China Innovation and Entrepreneurship Competition, and the "Top 50 Innovative Enterprises in China," among others.
