Antrogen announced on the 4th that it has obtained top-line results from its Phase 1 clinical trial of 'ANT-301,' a cell therapy for the treatment of severe knee osteoarthritis. The company stated that no adverse drug reactions or dose-limiting toxicities (DLTs) were observed in any dose group, confirming the drug's safety and tolerability.

Trial Overview This domestic single-center Phase 1 clinical trial targeted patients with Kellgren-Lawrence (K&L) Grade 3-4 severe knee osteoarthritis and was conducted at Seoul National University Hospital with a total of 6 subjects (up to a maximum of 12). According to the safety evaluation, the primary endpoint, not a single adverse drug reaction related to the investigational product occurred, and no DLTs were observed in any dose group, demonstrating excellent safety and tolerability.

Exploratory Efficacy Results Compared to baseline, the pain indicator VAS improved by 55.3%, the functional assessment WOMAC by 27.6%, and IKDC by 27.9%. Additionally, MRI WORMS and X-ray assessments confirmed that joint condition was either improved or maintained.

Limitations and Future Plans The company noted that these results represent top-line data from an exploratory Phase 1 trial, and the limited number of subjects presents constraints on determining statistical significance. As safety assessment was the primary objective, the company plans to further verify efficacy in subsequent clinical trials. Antrogen intends to secure the final Clinical Study Report (CSR) for the same target group and establish a follow-up clinical development strategy based on these data.

Investment Caution The probability of an investigational drug receiving final marketing approval is statistically known to be approximately 10%, and outcomes during the clinical and product approval processes may differ from expectations. There is also a possibility that commercialization plans may be altered or discontinued. As this Phase 1 trial focused on safety with only 6 subjects, there are limitations in interpreting the efficacy results and differences between dose groups. Investors should carefully make decisions by comprehensively considering the investment risks disclosed in periodic disclosures and business reports.