Hanmi Pharm’s investigational non-alcoholic hepatosteatosis (NASH) drug has gained a new boost for clinical development with unanimous recommendation from an expert panel of U.S. Food and Drug Administration (FDA) for the continuation of a Phase 2 global study.

The Korean pharmaceutical company said on Wednesday the members of the FDA’s Independent Data Monitoring Committee (IDMC) unanimously recommended that the Phase 2 global clinical trial of its LAPSTriple Agonist, a fatty liver disease drug, should continue as planned after review of unblinded data from randomized patients.

LAPSTriple Agonist is a candidate for a triple-acting first-in-class drug that simultaneously activates glucagon, which increases energy metabolism, GLP-1 that promotes insulin secretion and suppresses appetite, and GIP receptors that regulate adipose inflammation.

The drug was granted fast track designation from the FDA in 2020 to expedite drug development for NASH treatment. In 2021, orphan drug designation was added for the treatment of idiopathic pulmonary fibrosis.

Hanmi Pharm is conducting Phase 2 clinical trials across the U.S. and Korea to evaluate the drug’s efficacy, safety and tolerability in patients diagnosed with NASH by liver biopsy.

By Chung Seul-gi and Minu Kim

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