MediPost Receives Approval for Phase 2 Clinical Trial Plan of Injectable Knee Osteoarthritis Treatment

[Asia Economy Reporter Lee Chun-hee] Medipost's injectable knee osteoarthritis treatment 'SMUP-IA-01' is entering Phase 2 clinical trials in South Korea.

Medipost announced on the 27th that the Phase 2 clinical trial plan for the next-generation injectable knee osteoarthritis treatment SMUP-IA-01, submitted to the Ministry of Food and Drug Safety last July, has been approved.

The main ingredient of SMUP-IA-01, 'SMUP Cell,' is a high-efficacy allogeneic umbilical cord blood-derived mesenchymal stem cell produced using Medipost's next-generation stem cell platform technology. SMUP-IA-01 not only demonstrates excellent therapeutic efficacy but can also be mass-produced through bioreactors, enabling reductions in production time and cost. Additionally, its frozen formulation resolves storage and distribution issues, which is expected to overcome challenges in commercialization and entry into the global market.

The domestic Phase 2 clinical trial will involve 90 patients with mild to moderate (K&L grade 2?3) knee osteoarthritis. SMUP-IA-01 will be administered once via intra-articular injection into the knee joint, followed by a one-year observation period to evaluate safety and exploratory efficacy. The optimal dosage for Phase 3 clinical trials will also be determined. This trial will be conducted at three institutions: Seoul National University Hospital, Severance Hospital in Sinchon, and Bundang Seoul National University Hospital.

According to the Health Insurance Review and Assessment Service, the number of knee osteoarthritis patients in South Korea was estimated to be 2.78 million as of last year. The number is increasing annually as the society ages. However, patients with mild to moderate (K&L grade 2?3) knee osteoarthritis, who account for 65% of all patients, can only expect temporary symptom relief through conservative treatments such as painkillers or hyaluronic acid (HA) injections. Regenerative medicine, including stem cell therapies like SMUP-IA-01, is emerging as a new strategy for developing fundamental treatments.

A Medipost representative stated, “SMUP-IA-01 is expected to be an alternative for patients experiencing treatment gaps who do not respond to drug therapy or hesitate to undergo surgery,” adding, “Together with Cartistem, the blockbuster first-generation cell therapy, it will contribute to improving the quality of life for osteoarthritis patients.”