GobioLab Applies to US FDA for Clinical Trials of Microbiome New Drug

[Asia Economy Reporter Minwoo Lee] Gobiolab announced on the 4th that it has submitted an application for a Phase 2a clinical trial plan for its microbiome drug KBL697 to the U.S. Food and Drug Administration (FDA).

This Phase 2a clinical trial will be conducted in Australia, targeting patients with mild to moderate ulcerative colitis. After pre-treatment with vancomycin, KBL697 will be administered, and its efficacy and safety will be evaluated to confirm the therapeutic effect.

The company stated, "KBL697 demonstrated safety and tolerability in the Phase 1 trial with no clinically significant adverse reactions, suggesting it can be developed as an ulcerative colitis treatment with low toxicity and side effects."