[E-Daily Reporter NA EUN-KYUNG ] ANTEROGEN CO., LTD.(065660)announced on the 13th that, following the approval in Japan of “ALLOSTEM,” a treatment for dystrophic epidermolysis bullosa (DEB), it will now move full steam ahead with a Phase 2 clinical trial in the U.S. and global development.

The Japanese approval was secured jointly with Ishin Pharma, ANTEROGEN CO., LTD.’s licensing partner in Japan and Taiwan. The full Common Technical Document (CTD) was submitted for the approval application, with ANTEROGEN CO., LTD. responsible for preclinical and CMC (Chemistry, Manufacturing, and Controls) data, and Ishin Pharma responsible for clinical data.

ANTEROGEN CO., LTD. has received approval from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug (IND) application for the DEB indication and has also secured approval from the Institutional Review Boards (IRBs) at Stanford University Hospital and the University of Miami Hospital. Professor M. Peter Marinkovich of Stanford University School of Medicine and Professor Schmidt of the University of Miami will serve as principal investigators for the U.S. Phase 2 clinical trial.

The company has set “Complete Wound Closure” as the primary endpoint for the U.S. Phase 2 clinical trial and plans to discuss a global Phase 3 clinical development strategy with the FDA based on the clinical results.

Additionally, following a review of Alostem’s mechanism of action, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) approved indications not only for DEB but also for junctional epidermolysis bullosa (JEB) and severe EB. Based on this, the company plans to pursue entry into the U.S. and European markets in the future.

ANTEROGEN CO., LTD. official stated, “Based on the Japanese approval, we are now fully launching our entry into the U.S. and European markets,” adding, “We will objectively demonstrate the therapeutic value of Allostem through global clinical trials.”