Aprogen's Arthritis Drug Clinical Trial Preparation Progresses Smoothly... Drawing Attention by Making a Limping Dog Run

Aprogen is accelerating preparations for clinical trials of its arthritis new drug.

Aprogen announced on the 7th that preparations for clinical trials of AP209, an arthritis new drug that gained attention for enabling dogs limping from degenerative arthritis to run, are progressing smoothly. This new drug is a bispecific receptor innovative drug (First in Class) developed independently by Aprogen.

The drug showed pain relief, recovery of walking function, and remarkable improvement of joint lesions in an osteoarthritis beagle model test. The company expects it to become the first fundamental treatment for degenerative arthritis.

Preclinical toxicity tests of AP209 are being conducted on 104 monkeys by the global CRO company Japan SNBL (Shin Nippon Biomedical Laboratories). So far, no toxicity caused by AP209 has been observed in single and repeated dose toxicity tests, and the preclinical test report is scheduled to be submitted to Aprogen by September.

In a recent human tissue cross-reactivity test, Aprogen also secured results showing that AP209 does not exhibit nonspecific cross-reactivity with human tissues. A company official explained, “These results suggest that the possibility of AP209 binding to cells or tissues other than the target substance and causing toxicity is very low.”

The production of the master cell bank (MCB) and working cell bank (WCB) for the AP209 active pharmaceutical ingredient and their characterization analysis were completed by the US company BioReliance at the end of last year and delivered to Aprogen Biologics Osong Plant. Aprogen has completed the culture, purification, finished product process, and formulation development necessary for clinical trial drug production and has transferred the technology to Aprogen Biologics, which is in charge of production. Currently, Aprogen Biologics is preparing for trial operation for AP209 production and plans to complete clinical sample production within the first half of the year.

Aprogen aims to apply for clinical trial approval within this year. Over the past few months, it has been selecting a CRO from six domestic and international clinical trial organizations and recently finalized the candidate. The AP209 clinical trial will be conducted on patients starting from Phase 1. The company expects that upon completion of Phase 1, not only the drug’s safety but also the therapeutic effect of AP209 can be primarily verified.

A company official said, “If the safety of the drug is proven and effects such as pain relief and structural improvement of joint lesions are verified in future clinical trials, AP209 is expected to become a blockbuster-level bio new drug that can change the landscape of the osteoarthritis market, where no treatment currently exists.”