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Kangstem Biotech strives to develop an innovative new drug for patients suffering from rare and incurable diseases.
Expectation of results in OA Phase 1 medium-dose group
16
2024.05
The mid-dose arm of the Phase 1 clinical trial of Furestem-OA Kit Kangstem Biotech's osteoarthritis treatment, has entered the finalization phase.
The mid-dose arm of the Phase 1 clinical trial of Furestem-OA Kit Kangstem Biotech's osteoarthritis treatment, has entered the finalization phase. We plan to complete patient observation and begin MRI-based imaging analysis by the end of May.
In the mid-dose arm, where we have high expectations for a radical treatment, pain reduction was rapid in all patients early in the study and has been sustained since the single dose. In particular, as time passes, the clinical patients are showing clear therapeutic effects, such as significant improvement in joint function, which is expected to have a significant impact on the fundamental treatment of osteoarthritis.
In addition, the MRI-based imaging assessment of patients in the low-dose arm, announced in April, confirmed that all patients in the study showed localized cartilage regeneration, and all three patients showed improvement in synovial inflammation on the Osteoarthritis Overall Rating Scale (WORMS). In addition, two of the subjects demonstrated cartilage regeneration and improvement in the structure of the subchondral bone, and one patient demonstrated improvement in most subcategories, including WORMS total score.
The low-dose arm of the trial, which is the lowest dose of stem cells, has demonstrated pain control, cartilage regeneration, and positive imaging results that exceeded expectations. The mid-dose and high-dose trials, which are currently in their final stages, are showing significantly greater improvement than the low-dose trial, with the potential for even greater structural improvement and a breakthrough treatment.
In the mid-dose arm, which is expected to be completed by the end of May, a single injection has been shown to reduce pain and improve by more than 60-70% compared to pre-dose, resulting in structural improvements such as cartilage regeneration in the knee joint that are more pronounced than in the low-dose arm. In addition, all patients who completed the treatment from the low to high dose have not experienced any significant side effects, and as the injected cells differentiate into chondrocytes and directly contribute to the regeneration of cartilage tissue, we expect a fundamental treatment effect for osteoarthritis that is safe without surgery.
We expect to complete patient observation in the mid-dose arm within the month and will rapidly move forward with MRI image analysis to accelerate ongoing out-licensing discussions.
Based on the top-line data from the Phase 3 clinical trial for atopic dermatitis, which is expected in June, and the results of the MRI imaging evaluation of the mid-dose arm of the Phase 1 clinical trial for osteoarthritis, Kangstem Biotech will apply for a marketing authorization for atopic dermatitis and pursue early technology export for osteoarthritis.