BioSolution announced on the 14th that it has received approval from the Ministry of Food and Drug Safety (MFDS) for the Investigational New Drug (IND) application for its Phase 1/2a clinical trial of 'Sperocure,' an allogeneic chondrocyte spheroid therapy.

This trial is a multi-center Phase 1/2a clinical study designed to evaluate the safety, tolerability, and efficacy of Sperocure in patients diagnosed with Kellgren & Lawrence (K&L) Grade 2 or 3 knee osteoarthritis. The clinical trial plan was submitted on November 10, 2025, and approved by the MFDS on July 13, 2026.

Phase 1: Confirming Maximum Tolerated Dose Through Dose Escalation

Phase 1 will be conducted as a multi-center, dose-escalation, open-label study. Doses will be administered sequentially from a low-dose group to a mid-dose group and then a high-dose group, applying the traditional '3+3' dose-escalation design to determine the Maximum Tolerated Dose (MTD). Each dose group will consist of 3 to 6 subjects, with a total of up to 18 participants expected. The primary endpoint of Phase 1 is the determination of the MTD through Dose-Limiting Toxicity (DLT) assessment.

Phase 2a: Evaluating Safety and Efficacy via Placebo-Controlled, Double-Blind Method

Phase 2a will be conducted as a multi-center, placebo-controlled, dose-expansion, randomized, double-blind study. The MTD identified in Phase 1 and one dose level below it will be compared with a placebo group to evaluate safety and efficacy, with a target of 41 to 68 total subjects. The primary efficacy endpoints for Phase 2a are the change in pain scores on the 100mm Visual Analog Scale (VAS) and the change in WOMAC function scores at 24 weeks post-administration.

The clinical trial period will span 24 months from the date of the first subject enrollment following Institutional Review Board (IRB) approval to the final visit of the last subject, with an expected completion date of January 31, 2029.

Through this trial, BioSolution plans to evaluate the safety, tolerability, and efficacy of an intra-articular injection of Sperocure into the knee joint and to confirm its future development potential.

Meanwhile, through its investment precaution notices, the company informed that the statistical probability of the investigational drug receiving final product approval is approximately 10%, and that if the results during the clinical trial and approval process fall short of expectations, there is a possibility that commercialization plans may be altered or discontinued.