The injectable drug for knee osteoarthritis developed by MEDIPOST has entered phase 2 of full-scale clinical trials in Korea.

MEDIPOST (CEO: Yang Yoon-sun, KOSDAQ 078160) announced on the 22nd that the phase 2 clinical trials of the injectable drug for knee osteoarthritis SMUP-IA-01, which received approval from the Ministry of Food and Drug Safety in October, have been initiated. The phase 2 clinical trials in Korea were started at Seoul National University Hospital and will be continued at Severance Hospital and Seoul National University Hospital in Bundang.

This clinical trial will involve 90 patients with mild to moderate knee osteoarthritis (K&L grade 2-3). The clinical trials are designed to administer a single injection of SMUP-IA-01 into the knee joint cavity for each of the 30 subjects in low-dose groups, medium-dose groups, and active control groups. Following this, safety and exploratory efficacy will be evaluated through an observation period of one year. The optimal dose to be used in phase 3 of clinical trials will also be confirmed.

In SMUP-IA-01’s phase 1 clinical trials in Korea, 12 patients with knee osteoarthritis were given a single injection into their knee joint cavity at Seoul National University Hospital. The response to the drug was then evaluated for 6 months, and the results were shown to demonstrate the safety and improvement of joint function and pain.

Meanwhile, the SMUP-Cell, the active ingredient of SMUP-IA-01, is a highly efficacious allogeneic cord blood-derived mesenchymal stem cell produced with stem cell platform technology independently developed by MEDIPOST. SMUP-IA-01 not only has excellent therapeutic efficacy but also can be mass-produced through a bioreactor, making it possible to reduce both production time and cost. Furthermore, SMUP-IA-01 is rated to have overcome the difficulties in the commercialization and entry into the global market processes of first-generation cell therapy products; these difficulties were resolved by using a frozen formulation, which solves issues in the drug’s storage and distribution.

[Glossary]

· SMUP-IA-01: This is an injectable drug for knee osteoarthritis developed with SMUP-Cell, a “high-efficiency and low-cost” cell culture platform technology that enables the selection, separation, and mass-production of high-efficiency cells through bioreactors, as well as storage under normal refrigeration for easy transportation and long-term storage. This has allowed the company to overcome limitations in production, storage, and commercialization that existed for first-generation cell therapy.

· Kellgren Lawrence (K&L) Classification: The degree of osteoarthritis symptoms is evaluated through a knee X-ray. Depending on the gap between the knee bones, the symptom is rated in grades from 0 to 4. When the cartilage between the knee bones is normal, the symptom is rated as 0. The grade increases as the cartilage wears out and the gap between the knee bones narrows. Grade 1 can be treated with drugs, and grades 2-3 can be treated by injection, surgery, or CARTISTEM^®. Grade 4 requires arthroplasty.