[Edaily Reporter Kwon Oh Seok ] Aprogen(007460)is accelerating its entry into full-scale clinical trials after completing the first phase of clinical procedures for “AP209,” a new drug candidate for degenerative arthritis currently under development.

Aprogen announced on the 30th that, following its recent approval of the Investigational New Drug (IND) application for AP209 from the Ministry of Food and Drug Safety, it submitted the necessary documents to the Institutional Review Board (IRB) at Kyung Hee University Hospital on the 29th to initiate the clinical trial. The submitted documents included the clinical trial protocol, patient consent forms, a list of trial sites and investigators, case report forms (CRFs), and the investigator’s brochure, thereby completing the paperwork required to begin the trial.
After launching the first clinical trial at Kyung Hee University Hospital, the company is currently in discussions with three additional university hospitals regarding their participation. The strategy is to accelerate the development timeline by shortening patient recruitment and trial duration through a multi-center clinical trial.
Aprogen is focusing on the joint-protective and functional improvement effects of AP209 confirmed in preclinical trials. According to the company, AP209 demonstrated results in a beagle model of arthritis that reduced pain, restored walking function to normal levels, and improved joint damage.
In particular, since the drug’s efficacy was more pronounced in animals with larger joints, the company expects that similar therapeutic effects can be achieved in Saramin—whose knee joint surface area is approximately 13 times larger than that of beagles—using relatively lower doses and longer dosing intervals.
AP209 is a new drug candidate featuring a “bispecific receptor” structure that utilizes two types of human-derived receptors that bind to growth factors; it is characterized by adopting a platform different from that of existing bispecific antibodies. Aprogen announced that, based on its own research, AP209’s bispecific receptor platform replicates the binding characteristics of arthritis-related growth factors in a manner closer to physiological conditions, demonstrating superior therapeutic effects in terms of pain relief and joint protection compared to bispecific antibodies targeting the same target.
This clinical trial is scheduled to be conducted at three to four university hospitals, including Kyung Hee University Hospital, with 16 patients with osteoarthritis. Patients will be monitored for approximately 13 weeks following intra-articular administration of the drug into the knee joint; the initial trial will focus on confirming and verifying safety, pharmacokinetics (PK), and therapeutic efficacy.
The company also emphasizes the significance of AP209’s mechanism of action. An Aprogen official stated, “AP209 works by inhibiting the excessive proliferation of sensory neurons and inflammatory immune cells—which cause pain in osteoarthritis—while simultaneously suppressing osteoclasts that destroy cartilage and activating osteoblasts that induce cartilage formation.” The official added, “We expect it to become an innovative osteoarthritis treatment that not only alleviates pain but also prevents and repairs joint damage itself.”