Regulator rejects Medipost's application to expand Cartistem's indication for ankle joint treatment

The Korean regulator has put on hold Medipost's plan to launch Cartistem, its stem cell therapy, as a treatment for the ankle joint.

Medipost announced on Tuesday that the Ministry of Food and Drug Safety (MFDS) has rejected its application to amend the license for Cartistem, its allogeneic cord blood-derived mesenchymal stem cell product, to include the indication for talus/osteochondral defects of the ankle joint.

According to the company’s public disclosure, the MFDS rejected the application because, although the statistical significance of the efficacy endpoint in the phase 3 clinical trial was confirmed, it was not sufficient to demonstrate clinical utility.

The phase 3 study aimed to evaluate the effectiveness of Cartistem in combination with the existing treatment, micropuncture, for patients with ankle joint injuries. A total of 102 patients (50 in the test group and 52 in the control group) were treated across six hospitals in Korea between March 2020 and June 2022.

The results showed that the ICRS cartilage repair assessment score at 48 weeks post-surgery was 10.541±0.326 in the test group and 9.547±0.312 in the control group, indicating a statistically significant difference (p=0.0309).

Medipost stated that, based on the ministry’s review and the phase 3 results, it is in discussions with the clinical trial licensee, Hyundai Bioland, regarding the possibility of conducting an additional phase 3 study to confirm clinical utility.

In January 2019, Medipost entered into an exclusive domestic distribution agreement with SK Bioland for Cartistem's ankle joint indication. Under the agreement, Medipost was set to receive a minimum order value of 15.6 billion won and 15 years of sales royalties for a 10-year period following approval.