Hanmi Pharmaceutical said on the 2nd that it completed the first patient dosing in a U.S. phase 2 trial of the triple agonist "HM15275."
It comes about three months after receiving approval for the phase 2 investigational new drug (IND) application from the U.S. Food and Drug Administration (FDA) in September last year. The triple agonist is a drug designed to boost weight-loss effects by simultaneously stimulating three different receptors involved in weight control and energy metabolism.
In phase 2, the company will verify differentiated efficacy in reducing weight and improving lean mass in patients with obesity and severe obesity during 36 weeks of long-term dosing. The trial is expected to conclude in the first half of next year.
The target for commercialization is 2030. The indication will also be expanded to diabetes. The company received related phase 2 IND approval from the FDA last month. The trial is scheduled to begin in the first half of this year.
Park Jae-hyun, CEO of Hanmi Pharmaceutical, said, "We will further accelerate new drug development and rise as a global top-tier corporations."