Hanmi Pharm Applies for Phase 1 Clinical Trial in the US of Next-Generation Obesity Treatment with 'Triple Action'

Hanmi Pharmaceutical announced on the 1st that it submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) on the 29th of last month (local time) to enter Phase 1 clinical trials for HM15275, a next-generation triple-action obesity treatment.

Hanmi Pharmaceutical Headquarters Exterior [Photo by Hanmi Pharmaceutical]

This clinical trial will be conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HM15275 in healthy adults and obese patients. Hanmi Pharmaceutical aims to commercialize HM15275 by 2030 and submitted an IND to the Korea Food and Drug Administration in February.

HM15275 is a next-generation obesity drug currently under development following Epeglenatide, which is in Phase 3 clinical trials. It combines three mechanisms of action: glucagon-like peptide-1 (GLP-1) receptor agonists, which have recently caused a sensation due to their strong weight loss effects, along with glucose-dependent insulinotropic polypeptide (GIP) and glucagon receptor agonists. In particular, it is designed to optimize the action on each receptor to achieve “more than 25% weight loss while minimizing muscle loss.”

Hanmi Pharmaceutical plans to present several key research results on HM15275 at the 2024 American Diabetes Association (ADA) conference to be held in the U.S. this June.

Choi In-young, Head of Hanmi Pharmaceutical’s R&D Center, said, “Based on our long-standing R&D capabilities in the metabolic disease field, we continue to create new innovative possibilities in the obesity area, which has become a global social issue. Hanmi’s R&D innovation, filled with passion and determination toward becoming a pharmaceutical powerhouse, will never stop.”

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