Artivila Biopharma Announces Clearances of IND Applications for ARD-885 by Chinese NMPA and US FDA for the Treatment of Rheumatoid Arthritis

ShenZhen, Guangdong, China. December 11, 2024- Artivila Biopharma today announced that the Chinese National Medical Products Administration (NMPA) and the United States Food and Drug Administration (FDA) have approved its Investigational New Drug (IND) applications for its small molecule new drug ARD-885 for the treatment of rheumatoid arthritis (RA). It marks Artivila ’s advancement from pre-clinical stage into a clinical stage company formally.

About Rheumatoid Arthritis (RA)

RA is a common chronic, inflammatory and systemic autoimmune disease with a global incidence of 0.5% to 1%, and there are more than 5 million RA patients in China alone. RA is also a highly disabling disease, making it an important health issue causing disability in the Chinese population. Furthermore, with the prolongation of the disease, the disability rate of RA patients continues to rise. Despite recent developments in RA therapies, there are still a large number of RA patients, especially those with moderate to severe active RA, whose treatment needs have not been met, and RA drugs with new mechanisms need to be developed urgently.

About ARD-885

ARD-885 is a class 1 new drug of dual-target inhibitor for IRAK4 and IRAK1 developed by Artivila. Its in vivo and in vitro efficacies are superior to those of similar single-target drugs. It is one of the core products of Artivila, and its successful IND application is an important milestone for Artivila in the research and development of new drugs.

ARD-885, as the first dual-target small molecule Class 1 auto-immunotherapy drug targeting IRAK4 and IRAK1 at the same time, is expected to provide a new treatment strategy for rheumatoid arthritis patients. Pre-clinical in vivo efficacy data have shown that ARD-885 could significantly ameliorate clinical symptoms of arthritis, inhibit arthritic clinical scores, reduce volume of foot swelling, and improve pathological damages of joint tissues in a dose-dependent manner. Preclinical pharmacokinetic and toxicological studies showed that ARD-885 has a good pharmacokinetic and safety profile.

In addition to rheumatoid arthritis, ARD-885 can also be extended to other inflammatory diseases and autoimmune diseases, and is expected to be used in the treatment of tumors, so its clinical development prospects are broad.

About Artivila Biopharma

Artivila Biopharma is a drug discovery and development company based on its AI innovative drug discovery platform. The unique data and computing driven drug discovery platform (AI+HI) integrates artificial intelligence，cloud computing, cheminformatics, bioinformatics, drug design and the scientific leaders‘ rich industry experience into one team, which significantly reduces research and development (R&D) costs and shorten the R&D cycle. Artivila has an integrated AI/CADD R&D system and a team of top scientists focused on the fields of neurodegenerative diseases, oncology and autoimmune diseases. The company has five targeted innovative drugs entered the preclinical stageand has applied nearly 30 Chinese and global invention patents.

Since its establishment, Artivila has completed several rounds of financing and won the recognition of many professional investors and comprehensive funds in biomedicine, ensuring the rapid and steady development of the company. Artivila's projects and platform technology have also been recognized and supported by many parties and won numerous awards in innovation and entrepreneurship competitions.

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.