Liveome has received approval from the Australian Human Research Ethics Committee (HREC) for the phase 1 clinical trial of its microbiome drug LIV001 to treat inflammatory growth disorders.

Liveome is an affiliate of Medytox, the Korean botulinum toxin maker. 

In September, Liveome plans to start a phase 1a study in Australia to confirm the safety, tolerability, and pharmacokinetics of LIV001. It will then conduct a multinational phase 1b study in patients with inflammatory growth diseases to evaluate its efficacy.

LIV001, which Liveome is developing, is a microbiome therapy based on gene recombination technology developed to enhance the therapeutic effect on immune diseases by introducing immunomodulatory efficacy genes into microorganisms.

"The clinical approval of LIV001 means that we have proven our outstanding technology and R&D capabilities in the global market by solving the strict clinical entry barriers required for gene recombination-based microbiome therapies with our capabilities," Liveome CEO Song Ji-yoon said. "We will focus on the successful clinical progress of LIV001 and deriving various new drug candidates to become a leading company in next-generation microbiome therapies."

LIV001 was also selected as a new National New Drug Development Program project organized by the Korea Drug Development Fund (KDDF) in July and has since received related research and development subsidies.