Hanmi Pharmaceutical said on the 6th that it has begun a phase 1 clinical trial to develop a new-concept obesity breakthrough drug that reduces body weight while increasing muscle mass.
The company said it received approval for an investigational new drug (IND) application on the 4th (local time) from the U.S. Food and Drug Administration (FDA) to enter a phase 1 trial for a new-concept obesity treatment (code name HM17321). Through this trial, the safety, tolerability, pharmacokinetics, and pharmacodynamics of HM17321 will be evaluated in healthy adults and patients with obesity.
HM17321 is one of six pipelines in Hanmi Pharmaceutical's obesity new drug project H.O.P and is the third obesity drug candidate being developed, following the "efpeglenatide," for which the company recently released key topline results from a domestic phase 3 trial, and a triple-acting obesity treatment. Hanmi Pharmaceutical plans to advance clinical development of HM17321 with a commercialization target of 2031.
According to the company, HM17321 is a UCN2 analog that selectively targets the corticotropin-releasing factor 2 (CRF2) receptor, a neural receptor, rather than incretin receptors for blood glucose control hormones such as glucagon-like peptide (GLP)-1. UCN2 is a protein hormone that stimulates the CRF2 receptor to suppress appetite, increase energy expenditure and insulin sensitivity, and alleviate stress responses.
The company said, "HM17321 is designed as a peptide-based molecule, offering convenient administration and competitiveness in terms of expense," adding, "If developed as a combination therapy, it can be administered at the same time as existing incretin-class drugs, which are in the same peptide form."
Choi In-young, head of the R&D Center (executive director), said, "HM17321 is fundamentally differentiated from existing therapies in that it does not simply aim to lose weight but simultaneously pursues an integrated efficacy of 'fat reduction, muscle gain, and improvement of exercise and metabolic functions,'" adding, "We will open a new horizon in obesity treatment by providing patient-centered, customized solutions."