Antrogen Receives Approval for Phase 3 Clinical Trial Plan in Japan for Treatment of Skin Blistering Diseases
[Asia Economy Reporter Oh Ju-yeon] Antrogen announced on the 8th that it has received approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for a Phase 3 clinical trial plan to evaluate the efficacy and safety of ALLO-ASC-SHEET in patients with dystrophic epidermolysis bullosa.
Dystrophic epidermolysis bullosa is a genetic disorder caused by a defect in collagen 7, resulting in persistent blistering of the skin. The company explained that it is a fatal disease with a very high mortality rate, with many patients dying in infancy and childhood, and it is a rare disease that prevents patients from leading a normal life.
The company stated, "The purpose of this clinical trial is to develop a treatment that improves the quality of life for patients with dystrophic epidermolysis bullosa."
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They added that the Phase 2 clinical trial conducted under the approval of the Japanese PMDA confirmed the safety and tolerability of ALLO-ASC-SHEET and met the efficacy evaluation criteria for the Phase 3 trial.
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