Liveome, an affiliate of Medytox, said it completed the phase 1 clinical trial in Australia for its gene-recombinant microbiome drug, LIV001.

The drug is being developed as a treatment for inflammatory bowel disease, a chronic immune disorder that has been challenging to manage with existing therapies.

LIV001 represents the first gene-recombinant microbiome drug developed in Korea, utilizing microbial engineering to incorporate the immune-regulating peptide VIP gene into microbes.

Gene-recombinant microbiome therapies introduce specific genes into microbes to create live probiotic treatments. The clinical trial of LIV001 was carefully designed with a focus on safety, given the drug's reliance on genetically modified organisms (GMOs) for expressing foreign genes and aiming for increased effectiveness.

The trial involved 36 healthy volunteers and used a randomized, double-blind method to assess the drug's safety, tolerability, and pharmacokinetics with both single and multiple ascending doses.

Following a review by the Safety Review Committee, LIV001 was found to have a favorable safety and tolerability profile.

Based on these results, Liveome intends to proceed with multinational clinical trials to evaluate the efficacy of LIV001 further.

The company has already initiated discussions with the U.S. FDA in a Pre-investigational new drug (IND) meeting to review the requirements for global clinical trials.

"With the excellent safety and tolerability of LIV001 confirmed in this study, we are now focused on entering multinational clinical trials to confirm efficacy," Liveome CEO Song Ji-yoon said. "We will continue to accelerate the development of LIV001 to help position Liviome as a leader in the next generation of microbiome therapeutics."