GobioLab Initiates Global Clinical Trial for Second Microbiome New Drug

[Asia Economy Reporter Eunmo Koo] GobioLab announced on the 23rd that it has obtained approval for the Phase 1 clinical trial of its microbiome drug candidate ‘KBLP-002’ in Australia.

A GobioLab representative explained, “KBLP-002 is the second drug candidate discovered through our proprietary microbiome platform technology, SMARTiome™, and is a therapeutic candidate showing efficacy in various allergic immune diseases such as atopic dermatitis and asthma.”

Following the immune skin disease drug candidate 'KBLP-001', GobioLab has entered Phase 1 clinical trials for 'KBLP-002', accelerating the clinical progress of its key pipeline. The company stated, “GobioLab is the only domestic company conducting global clinical trials for microbiome drugs, and we expect to secure market leadership through new drug development.”

The first drug candidate, KBLP-001, has completed Phase 1 dosing and is preparing to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Phase 2 clinical trials. The company explained that through a Pre-IND meeting with the FDA last year, it has preemptively met the requirements necessary for global clinical trials of KBLP-001, so approval for the Phase 2 IND is expected to be straightforward.

A company representative added, “KBLP-002 will also undergo Phase 1 clinical trials to confirm safety, tolerability, and pharmacokinetics, and plans to submit an IND for Phase 2 clinical trials targeting patients with atopic dermatitis or asthma in the U.S. during the first half of 2021.”

GobioLab is a specialized company developing innovative microbiome-based new drugs, focusing on treatments for areas with high unmet medical needs such as autoimmune diseases (asthma, atopy, ulcerative colitis) and metabolic diseases (diabetes, non-alcoholic steatohepatitis).

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