KangStem Biotech said it has failed to prove the efficacy of Furestem-AD, an investigational stem cell therapy for atopic dermatitis, in a local phase-3 clinical trial.
The biotech firm said Thursday it could not secure statistical significance in the evaluation of Eczema Area and Severity Index-50 (EASI-50), the primary endpoint result, in the phase-3 study on 197 patients at 11 medical institutions last year, in comparison to the placebo group. EASI-50 refers to the percentage of patients whose eczema area shrank by more than 50 percent, compared to the baseline.
The trial tested stem cell therapy on patients with moderate to severe chronic atopic dermatitis (over 12 EASI scores). It divided patients into the placebo group and the treatment group half and half and observed for 12 weeks after one administration. The treatment group received a high dose of Furestem-AD that was highly effective in the phase-2 study.
However, only 31.82 percent of the treatment group achieved EASI-50, not statistically significant compared to 27.16 percent of the placebo group.
“Secondary endpoints, including mean change in EASI score and change in lesion involvement at week 12, significantly improved in the treatment group compared to the placebo group,” KangStem Biotech said.
The company added that data analysis at the fourth week showed significant changes in the mean EASI-50 scores and EASI scores in the treatment group, compared to the placebo group. This confirmed the responsiveness of Furestem-AD, it said.
KangStem Biotech said it would push ahead with trials for stem cell therapy.
“In July, we will conduct repeated-dose clinical trials for patients with atopic dermatitis and another study for various dosages, including combination therapy, at the same time. We hope to yield optimized results on efficacy within two years,” an official at KangStem Biotech said.
The company is working on a repeated-dose phase-2 study on Furestem-RA in patients with rheumatoid arthritis and an animal test on Furestem-OA targeting degenerative arthritis.
In the phase-2 study on Furestem-RA, the company completed administering the therapy to nine out of 30 participants. It is now jointly developing Furestem-OA with Heraeus Medical, a German medical device maker.
KangStem Biotech emphasized that it would do its best in winning trials in Europe and licensing-out deal with a foreign firm.