Medytox announced on the 24th that its affiliate Livbiome has completed the clinical trial application (CTA) for the approval of the Phase 1b clinical trial of the microbiome therapeutic LIV001.
Livbiome is developing the next-generation microbiome therapeutic LIV001 by introducing the immune-modulating peptide VIP gene, based on gene editing technology, into microorganisms for the treatment of inflammatory bowel disease. Considering the characteristics of inflammatory bowel disease, which requires lifelong treatment and maintenance after onset, the goal is to develop an oral drug with excellent safety and a novel mechanism of action.
This Phase 1b clinical trial will be conducted as a multinational study in Europe. It will observe drug safety and exploratory efficacy endpoints in adult patients with mild to moderate active ulcerative colitis. Based on the drug efficacy results obtained from patients in this trial, Livbiome plans to expand global clinical trials to North America and Northeast Asia to confirm the efficacy of LIV001, while accelerating technology commercialization through global partnering.
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