Hanmi Science reported on Monday that its key subsidiary, Hanmi Pharmaceutical, has successfully administered the first dose to a patient in its Phase 2 clinical trial for HM15275, a next-generation triple-action obesity treatment. This milestone comes just over three months after receiving FDA approval for the Investigational New Drug (IND) application last September.
The 36-week Phase 2 trial aims to rigorously evaluate HM15275’s unique ability to reduce weight and improve lean body mass in patients with obesity and severe obesity. Patient enrollment has been progressing smoothly since the trial’s inception, with expectations that the recruitment momentum will further accelerate the overall clinical timeline.
Hanmi projects the Phase 2 trial to conclude in the first half of 2027, with a target commercialization date set for 2030. The company is committed to expediting the clinical development process. Industry analysts suggest that if the Phase 2 trial yields positive results, HM15275 could potentially overcome the limitations of current GLP-1-based therapies, positioning itself as a best-in-class treatment for severe obesity.
In a parallel development, Hanmi is broadening the scope of HM15275 to include diabetes treatment. The company secured the U.S. Food and Drug Administration (FDA) approval on January 2 for a separate Phase 2 IND to assess the drug’s efficacy in blood sugar control among diabetic patients. This trial is slated to begin in the first half of this year.
HM15275 is engineered to optimize the receptor actions of glucagon-like peptide-1 (GLP-1), gastric inhibitory peptide (GIP), and glucagon (GCG), potentially offering a comprehensive solution for obesity and various metabolic disorders.
GLP-1 receptor agonists are known to enhance satiety, promote weight loss, and improve insulin function, leading to better glycemic control. GIP complements these effects by amplifying the pharmacological benefits of GLP-1 receptor agonists while mitigating common gastrointestinal side effects such as nausea, vomiting, and diarrhea. Glucagon contributes to satiety regulation, energy expenditure, and lipid metabolism.
Hanmi believes that by leveraging these three pharmacological mechanisms, HM15275 could revolutionize the treatment landscape for obesity, type 2 diabetes, and cardiovascular diseases. The company aims to achieve weight loss results surpassing those of gastric bypass surgery, which typically yields up to 25% body weight reduction. Moreover, HM15275 is designed to preserve muscle mass through optimized metabolic pathways, potentially enhancing the quality of weight loss outcomes.
The pharmaceutical industry has recently seen a surge in the development of next-generation triple-action drugs, underscoring the growing importance of innovative approaches that synergize multiple pharmacological mechanisms.
Hanmi Pharmaceutical’s Chief Executive Officer (CEO), Park Jae-hyun, expressed his enthusiasm: The rapid progression of HM15275’s Phase 2 trial, from FDA submission to first patient dosing, showcases our efficiency. It is committed to accelerating its drug development pipeline, leveraging Hanmi’s unique creative prowess and cutting-edge research and development (R&D) capabilities to cement our position as a global pharmaceutical leader.