US-Korea NASH New Drug, FDA Advisory Committee Decides to Continue Clinical Trials

'Labstriple Agonist' in Phase 2 Clinical Trial
Independent Data Monitoring Committee Recommends "Continue"

Seoul Songpa-gu Hanmi Pharm Headquarters Building Exterior

[Asia Economy Reporter Chunhee Lee] Hanmi Pharmaceutical's new drug for non-alcoholic steatohepatitis (NASH), 'LAPS Triple Agonist,' is progressing smoothly in its global Phase 2 clinical trial.

Hanmi Pharmaceutical recently announced on the 4th that it received a unanimous recommendation from the independent Data Monitoring Committee (iDMC) to "continue the Phase 2 clinical trial without any protocol changes," and plans to proceed continuously with the Phase 2 trial.

The iDMC is an independent advisory committee to the U.S. Food and Drug Administration (FDA), consisting of experts who independently monitor patient safety and drug efficacy during ongoing clinical trials. This independent committee operates to ensure safety and scientific validity in clinical trials, continuously monitoring ongoing trials and advising the trial sponsors on decisions such as "continuing the trial," "delaying patient recruitment," "modifying trial design," or "terminating the trial." The LAPS Triple Agonist received its second unanimous recommendation to continue the trial, following the first in October last year.

The LAPS Triple Agonist is a 'first-in-class' bio-innovative drug that simultaneously activates glucagon, which increases energy metabolism in the body; GLP-1, which aids insulin secretion and appetite suppression; and GIP receptors, which promote insulin secretion and have anti-inflammatory effects. Previously, the FDA designated the LAPS Triple Agonist as a fast-track development drug for NASH treatment in 2020, and later also granted it orphan drug status for the treatment of primary biliary cholangitis, primary sclerosing cholangitis, and idiopathic pulmonary fibrosis.

Hanmi Pharmaceutical is currently conducting a Phase 2 clinical trial in Korea and the United States to evaluate the efficacy, safety, and tolerability of the LAPS Triple Agonist compared to placebo in NASH patients diagnosed via liver biopsy.

Sechang Kwon, CEO of Hanmi Pharmaceutical, stated, "We will consolidate Hanmi's research and development (R&D) capabilities to ensure that the LAPS Triple Agonist, which is being developed for various indications beyond NASH, can ultimately become an innovative drug that dramatically improves patients' quality of life."

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