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Bio Solution has unveiled the final results from its phase 3 clinical trial of CartiLife (autologous chondrocytes), an autologous chondrocyte therapy intended to determine its approval for marketing. Earlier this year, the company received a warning from the Ministry of Food and Drug Safety (MFDS) for poor clinical trial quality control.
In a public filing on Thursday, Bio Solution announced that it has received the final clinical study report (CSR) for CartiLife's phase 3 clinical trial in Korea. The study was conducted at 19 medical centers, including Kyung Hee University Hospital, and involved 104 patients with knee articular cartilage defects. Participants were divided into a test group (52 patients) and a control group (52 patients) to compare the efficacy and safety of autologous-derived chondrocyte therapy (CartiLife) implantation and conventional micro-drilling.
(Source: Bio Solution's website)
(Source: Bio Solution's website)
The primary endpoints were MRI imaging assessment (MOCART total score) and knee function assessment (KOOS total score change) at 48 weeks postoperatively. The trial aimed to demonstrate superiority for the MOCART score and non-inferiority for the KOOS score.
In the full analysis (FA), the CartiLife treatment group had a MOCART total score of 55.81±17.35 at 48 weeks, compared to 46.16±19.47 in the micropuncture control group, a statistically significant difference (p=0.0196).
The KOOS total score of the 84 patients in the per-protocol (PP) analysis also showed a significant improvement in the CartiLife treatment group, with a 30.26-point increase from baseline compared to a 28.64-point increase in the control group. The lower bound of the score difference between the two groups was -6.41, which is above the -8 point threshold for non-inferiority, statistically confirming CartiLife's non-inferiority to the control group.
Following the positive results from CartiLife's 48-week primary efficacy trial in April last year, which met the primary endpoint, Bio Solution stated that the final analysis also confirmed CartiLife's superiority through 96 weeks of long-term follow-up, with favorable outcomes on secondary efficacy endpoints and various patient population analyses.
Bio Solution will submit the results to the MFDS and proceed with the formal approval process. The company received conditional approval for CartiLife from the MFDS in April 2019, and the product is currently on the market. Since receiving conditional approval, Bio Solution has been further verifying CartiLife’s efficacy and safety through a domestic phase 3 study and completed 96 weeks of long-term follow-up for the last patient in December last year.
Bio Solution plans to present the trial results at the upcoming American Academy of Orthopaedic Surgeons (AAOS) meeting on March 10 in San Diego, the U.S.
In January, Bio Solution was sanctioned by the MFDS for quality issues related to its clinical trials. The MFDS issued a warning to the company, citing insufficient quality control of clinical trial materials, including records related to the trials, and a failure to continuously evaluate the safety of investigational drugs.
In a subsequent statement, Bio Solution CEO Lee Jung-sun said that an investigation into the CartiLife clinical trials had been conducted, and there were demands for improvement. He also emphasized that Bio Solution, along with the CRO and 13 clinical trial sites, submitted implementation plans and related documents in response to the MFDS's concerns.
“The points were mostly related to some non-compliance with the relevant regulations of the MFDS and the lack of SOP (Standard Operating Procedure) procedures,” Lee said, adding, “This warning does not affect the reliability of the clinical trial or the approval process.”
Bio Solution reported 2024 revenue of 12.9 billion won ($8.9 million), a 3.42 percent year-on-year increase. However, the operating loss was 5.1 billion won, marking a 1.3 percent year-on-year widening. The net loss amounted to 12 billion won, a surge of 857.03 percent from 1.2 billion won in the previous year.
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Kim Chan-hyuk kch@docdocdoc.co.kr
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