Kangstem Biotech Makes Progress in Developing World's First Stem Cell Therapy for Atopic Dermatitis

Over 110 Patients Dosed in Phase 3 Clinical Trial
Targeting Completion of Dosing for 308 Moderate or Severe Patients Within the Year
"Expecting Significant Clinical Results Next Year"

[Asia Economy Reporter Hyungsoo Park] Kangstem Biotech announced on the 21st that the world’s first atopic dermatitis stem cell treatment, ‘Purestem-ADju,’ is progressing smoothly in its domestic Phase 3 clinical trial.

The Phase 3 trial aims for a fundamental treatment of atopic dermatitis through a single administration of Purestem-ADju. As of the 20th, administration has been completed for 110 patients. The company plans to complete administration within this year for a total of 308 patients with moderate or higher chronic atopic dermatitis across 21 institutions.

Atopic dermatitis is a chronic inflammatory skin disease characterized by repeated exacerbations and remissions accompanied by itching. Approximately 20?46% of all patients are reported to be in moderate to severe condition. When it reaches moderate to severe stages, it causes severe itching that interferes with daily life. Some patients hesitate to participate in clinical trials due to concerns about being assigned to the placebo group.

Kangstem Biotech’s Phase 3 trial has adopted a crossover design so that all participating patients can receive Purestem-ADju. The experimental drug group receives the drug first and then the placebo after 12 weeks, while the placebo group receives the placebo first and then the experimental drug after 12 weeks. This design reduces patients’ anxiety and effectively controls conditions that could affect efficacy analysis, such as rescue medications and concomitant drugs, thereby enhancing the objectivity of the results.

Yohan Bae, Head of Clinical Development at Kangstem Biotech, said, "Currently, it has been confirmed through clinical trial researchers that Purestem-ADju shows sustained effects even after a single administration and positive responses in patients who did not respond to existing treatments."

He added, "With the smooth progress of the clinical trial, expectations for a new mechanism of atopic dermatitis stem cell treatment are growing," emphasizing, "An environment conducive to participant recruitment is being established."

He also stated, "Clinical trials are expected to accelerate in the second half of the year," and "Meaningful clinical results are anticipated next year."

This content was produced with the assistance of AI translation services.