Hanmi Pharm said Wednesday that the Independent Data Monitoring Committee (IDMC) has recommended that the phase 2 clinical trial of efocipegtrutide (LAPSTriple agonist), a candidate for treating metabolic dysfunction-associated steatohepatitis (MASH), "continue without modification."

The IDMC was held in April to discuss the continuation of the trial based on interim data from the ongoing global Phase 2 trial of efocipegtrutide in Korea and the United States. The meeting discussed safety data from the 144 patients who received the drug.

In May last year, Hanmi Pharm conducted an interim analysis with IDMC to exclude three doses of efocipegtrutide (2, 4, and 6 mg/week) that could have been deemed ineffective. However, the interim results showed that none of the dose groups met the futility criteria, and the team was advised to continue development without excluding any dose group.

The IDMC expert group independently monitors patient safety and drug efficacy in advanced-stage clinical trials. It operates to ensure safety and scientific validity in randomized, double-blind clinical trials. It is an objective, independent committee that recommends the sponsor to continue the study, delay patient recruitment, modify the study design, or discontinue the study.

Efocipegtrutide is a triple-acting biologic that simultaneously activates glucagon, which increases the body's energy metabolism; GLP-1, which helps to increase insulin secretion and suppress appetite; and GIP receptors, which promote insulin secretion and have anti-inflammatory properties.

In July 2020, the U.S. Food and Drug Administration (FDA) designated efocipegtrutide as a fast-track development drug for treating MASH. The FDA and European Medicine Agency (EMA) have also granted it orphan drug designations for treating idiopathic pulmonary fibrosis (IPF), primary biliary cholangitis (PBC), and primary sclerosing cholangitis (PSC).

Hanmi Pharm is conducting a global Phase 2b study in the U.S. and Korea to determine treatment efficacy, safety, and tolerability compared to placebo in patients with biopsy-confirmed MASH with fibrosis. It will submit an abstract to the American Association for the Study of Liver (AASLD) international conference later this year.

"The IDMC's recommendation for continued development indicates that efocipegtrutide is meeting expectations in terms of efficacy and safety and is an objective indicator of its potential as a global new drug," a Hanmi Pharm official said. "We will continue to work hard to complete the development of the drug for MASH patients with high unmet need."