SCM Lifescience, a company specializing in the research and development of cell therapies, said on Tuesday that its stem cell therapy for atopic dermatitis, SCM-AGH, demonstrated efficacy and safety in phase 2 clinical trials.

The phase 2 study was conducted on 72 patients with moderate or severe atopic dermatitis with an Eczema Area and Severity Index (EASI) score of 16 or higher where half of the cohort was given the placebo. Three doses of SCM-AGH were administered two weeks apart and observed for 24 weeks.

The proportion of patients with a 50 percent reduction in EASI score (EASI-50) at 12 weeks was designated as the primary endpoint. Accordingly, the treatment group showed a statistically significant difference compared to the placebo group, meeting the primary objective and no serious adverse events were observed.

Additionally, the secondary endpoint, achieving EASI-90 at 24 weeks, also showed a statistically significant difference in the treatment group over the placebo.

Likewise, the proportion of subjects with an Investigator's Global Assessment (IGA) score of 0 or 1 and a 2-point or greater decline at 12, 16, and 24 weeks also improved significantly over the placebo.

Overall, the body surface area (BSA) measurement also demonstrated significant differences at 12 and 16 weeks, demonstrating the effectiveness of SCM-AGH in achieving the primary and secondary endpoints.

"The demonstration of efficacy at 12 weeks with SCM-AGH is significant for the treatment of moderate to severe atopic dermatitis that requires long-term treatment,” the company official explained. “We are refining the trial design to increase the likelihood of success in phase 3, with the ultimate goal of developing a successful stem cell therapy that is safe for patients and shows long-term therapeutic benefit beyond six months.”