GOBiolab Completes Phase 1 Clinical Trial of Microbiome-Based New Drug for Skin Disease Treatment

New Microbiome-Based Immunity Skin Disease Treatment Drug
Clinical Trial Application (IND) for Phase 2 to be Submitted to the U.S. FDA in June

[Asia Economy Reporter Eunmo Koo] GobioLab announced the results of the Phase 1 clinical trial of the new immunological skin disease treatment drug KBLP-001 on the 12th.

A GobioLab representative stated, “Regarding KBLP-001, a new drug for treating immunological skin diseases, the Phase 1 clinical trial results confirmed excellent safety tests and tolerability evaluations, successfully completing the first stage of drug development.” KBLP-001 is a pipeline developed by GobioLab as a new drug for treating immunological skin diseases, with confirmed effects of alleviating skin immune hypersensitivity reactions in cell experiments and animal models.

In this Phase 1 clinical trial, GobioLab demonstrated that the distribution of the drug in the body was proportional to the administered dose in safety and pharmacokinetic evaluations, and that the drug did not remain in the body after discontinuation. Furthermore, comprehensive examinations including physical exams and vital signs were completed for signs appearing after single or multiple doses, and excellent results were obtained in safety and tolerability evaluations. GobioLab plans to accelerate preparations for rapid entry into Phase 2 clinical trials based on additional analyses and results.

A GobioLab representative said, “Among the entire pipeline, two Phase 1 clinical trials will be completed this year, making it the fastest in the domestic industry,” and explained, “The company plans to submit an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) in June to proceed with Phase 2 clinical trials targeting psoriasis patients based on the clinical results.”

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