Korea-US NASH New Drug 'Labs Triple' Recommended for Continued Clinical Trials by IDMC

Hanmi Pharmaceutical announced on the 15th that the Independent Data Monitoring Committee (IDMC) has recommended to "continue without modification" the ongoing global Phase 2 clinical trial of the non-alcoholic steatohepatitis (NASH) treatment candidate, LAPSTriple Agonist.

Hanmi Pharmaceutical Headquarters Exterior [Photo by Hanmi Pharmaceutical]

The company explained, "This recommendation from the IDMC goes a step further than the previous three recommendations, which were based solely on the safety profile," adding, "It is significant because it was made based on an interim analysis that additionally evaluated the efficacy of the ongoing Phase 2 clinical trial."

Hanmi Pharmaceutical is currently conducting a Phase 2 clinical trial in the United States and Korea involving NASH patients confirmed by liver biopsy and accompanied by fibrosis, to assess treatment efficacy, safety, and tolerability compared to placebo.

The purpose of the IDMC's recommendation was initially to exclude any dose groups among the three doses under trial that might be deemed ineffective in terms of efficacy, alongside safety evaluation. However, the interim results showed no dose groups meeting futility criteria, allowing the trial to proceed to completion without excluding any specific dose groups.

A Hanmi Pharmaceutical representative stated, "Detailed data cannot be disclosed as the trial is being conducted in a double-blind manner," but added, "The IDMC recommendation suggests that the drug meets expected levels of efficacy and safety." However, the company also noted that the interim analysis results do not guarantee the final outcome, and no definitive conclusions can be drawn until the final clinical results are announced.

The IDMC is an expert group that independently monitors patient safety and drug efficacy during ongoing clinical trials. It operates to ensure safety and scientific validity in randomized, double-blind trials. As an objective independent committee, it advises the trial sponsors on continuing the trial, delaying patient recruitment, modifying the trial design, or stopping the trial.

The LAPSTriple Agonist is a triple agonist biopharmaceutical that simultaneously activates glucagon, which increases energy metabolism in the body; glucagon-like peptide-1 (GLP-1), which promotes insulin secretion and suppresses appetite; and glucose-dependent insulinotropic polypeptide (GIP) receptors, which stimulate insulin secretion and have anti-inflammatory effects.

In July of last year, the U.S. Food and Drug Administration (FDA) designated LAPSTriple Agonist as a Fast Track development drug for NASH treatment. It was also granted Orphan Drug Designation (ODD) for the treatment of primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), and idiopathic pulmonary fibrosis (IPF).

A Hanmi Pharmaceutical representative said, "Through this interim analysis and the IDMC recommendation, we were able to confirm the drug’s efficacy, safety, and potential for global new drug development," adding, "This will provide hope for patients seeking new treatment options and serve as an opportunity for related institutions and medical professionals to pay closer attention to future research processes."

This content was produced with the assistance of AI translation services.