Hanmi files phase 1 FDA IND for their next-gen obesity drug

This represents the second IND submission following the submission to the Ministry of Food and Drug Safety (MFDS)...Hanmi aims to commercialize the drug by 2030

Hanmi will present the research outcomes, including weight management and improvements in cardiovascular diseases, at the 2024 American Diabetes Association (ADA) conference

Hanmi Obesity Pipeline.

Hanmi Pharmaceutical announced on the 1st that it submitted an investigational new drug (IND) to the U.S.

 

FDA on March 29 for its triple-agonist (HM15275), a next-generation obesity drug.

 

Its IND includes a trial goal to assess drug tolerance, pharmacokinetics, and pharmacodynamics of HM15275 in healthy adults and patients with obesity.

 

Hanmi aims to commercialize HM15275 by 2030.

 

On February 29, Hanmi submitted an IND to the Ministry of Food and Drug Safety (MFDS) in Korea and is actively pursuing clinical development.

 

HM15275 is optimized to bind to glucagon-like peptide-1 (GLP-1), gastric inhibitory peptide (GIP), and glucagon (GCG).

 

It is anticipated that HM15275 will have an ‘effect of weight loss of 25% weight loss with minimal muscle loss.' Hanmi plans to present several accounts of their major research results at the 2024 American Diabetes Association (ADA) conference, which is scheduled for June in the United States.

 

At the conference, Hanmi will present the best-in-class potential and the mechanisms of action (MOA) of HM15275 in effective weight loss in obese model.

 

Additionally, the company will present results demonstrating the efficacy of HM15275 in various cardiovascular diseases model, which is known as one of the major causes of obesity.

 

Choi In-young, head of Hanmi Pharmaceutical's R&D Center, emphasized, “Hanmi has been continuously building innovative potential in the field of ‘obesity,’ a globally recognized social issue, based on our R&D capacity in the metabolic syndrome sector for a long period.” And added, “Hanmi is committed to pursuing R&D innovations with passion and tenacity to enhance the pharmaceutical power.” According to the WHO report published in the international research paper Lancet, as of 2022, the world's obese population is over 1 billion, more than double the number since 1990.

 

If current trends continue, it's estimated that the world's obese population will reach 1.9 billion by 2035.