Aprogen Signs Clinical CRO Contract and Begins Production of Clinical Trial Drug for Arthritis

Aprogen is accelerating the commercialization of its arthritis new drug.

On the 23rd, Aprogen announced that it has signed a clinical trial outsourcing contract with LSK Global Pharma Services Co., Ltd. (hereinafter ‘CRO’), a contract research organization, for the new drug AP209, which has shown the potential to be the first fundamental treatment for arthritis.

Currently, AP209 is undergoing preclinical trials on 104 monkeys through Japan’s Shin Nippon Biomedical Laboratories (SNBL). Production of the AP209 clinical trial drug is also underway at Aprogen Biologics’ factory located in Osong, Chungcheongbuk-do.

AP209 is one of the first-in-class new drugs developed using Aprogen’s proprietary bispecific receptor technology. In tests conducted by an external animal testing specialized CRO, a groundbreaking therapeutic effect was confirmed, enabling beagle dogs that could barely put their feet on the ground due to arthritis to run normally. It showed not only pain reduction and recovery of walking function but also remarkable improvement in joint lesions.

Professors and specialists advising Aprogen and the CRO that conducted the test evaluated these results as encouraging, proving the possibility that AP209 could become the first disease-modifying osteoarthritis drug (DMOAD) that fundamentally treats osteoarthritis.

LSK, selected as the clinical CRO for AP209, has conducted over 1,500 clinical contract research projects as of March this year. It is known as a highly reliable institution, having not received a single critical finding in the Ministry of Food and Drug Safety’s clinical trial inspections for product approvals over the past 22 years.

The AP209 clinical trial will be conducted on osteoarthritis patients. Accordingly, it plans to verify not only the safety of the drug but also the therapeutic effects of AP209. Early next month, at BioUSA to be held in Boston, USA, Aprogen plans to hold several individual meetings with major pharmaceutical companies from the US, Japan, and other countries that have shown interest, sharing detailed plans for these clinical trials.

A company official stated, “If the clinical trial conducted on arthritis patients verifies not only the safety of the drug but also pain relief and functional improvement effects, AP209 is expected to become a global blockbuster in the osteoarthritis market, where there is currently no fundamental treatment other than pain relief.”

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