Hanmi Pharm "Epeglenatide Confirms Cardiovascular Risk Reduction in Phase 3 Clinical Trial"

Global Clinical Results from 4,000 Patients Presented at the American Diabetes Association (ADA) Meeting

[Asia Economy Reporter Jihee Kim] Hanmi Pharmaceutical announced on the 29th that its long-acting bio-drug candidate, Epeglenatide, significantly reduced the incidence of major adverse cardiovascular events (MACE) and kidney diseases in a global large-scale clinical trial involving more than 4,000 patients.

According to Hanmi Pharmaceutical, Sanofi held an independent session for Epeglenatide at the American Diabetes Association (ADA) meeting on the same day and presented the results of the global large-scale cardiovascular Phase 3 clinical trial. The Phase 3 trial was conducted on 4,076 patients with type 2 diabetes or cardiovascular disease across 344 sites in 28 countries. Weekly doses of Epeglenatide at 4 mg, 6 mg, or placebo were administered.

The presentation showed that in patients with type 2 diabetes, monotherapy with both 4 mg and 6 mg doses significantly reduced the risk of cardiovascular and kidney disease events. Compared to the placebo group, the Epeglenatide-treated group showed a 27% reduction in major cardiovascular events and a 32% reduction in kidney disease incidence.

Seungjae Baek, Executive Vice President and Chief Medical Officer (MD) at Hanmi Pharmaceutical, stated, “Epeglenatide, which underwent rights reversion, has created a new opportunity to generate another innovation. We are focusing our company’s capabilities on expanding and concretizing the potential of Epeglenatide, as proven through the large-scale global Phase 3 clinical trial.”

Epeglenatide is a once-weekly GLP-1 receptor agonist diabetes treatment developed by Hanmi Pharmaceutical and licensed to Sanofi in 2015. Sanofi returned the rights last year due to changes in management strategy, and Hanmi Pharmaceutical currently holds the rights.

Additionally, Hanmi Pharmaceutical introduced another global Phase 3 clinical trial result of Epeglenatide at this ADA meeting, conducted on 406 patients with type 2 diabetes whose blood sugar was not controlled by diet and exercise. This double-blind trial divided patients into three dose groups (2 mg, 4 mg, 6 mg) of Epeglenatide over 56 weeks, with HbA1c as the primary endpoint at week 30, and HbA1c, weight loss, and safety compared to placebo at week 56.

The study results confirmed excellent blood sugar control and weight loss effects when Epeglenatide was administered to patients with type 2 diabetes. The therapeutic effects were stably maintained over a long period. At week 30, all doses showed statistically superior improvement in HbA1c compared to placebo. Significant weight loss was observed at the 4 mg and 6 mg doses, and the therapeutic effects on blood sugar control and weight loss were stably maintained for 56 weeks.

Sechang Kwon, CEO of Hanmi Pharmaceutical, said, “Many metabolic disease treatments marketed worldwide show potential cardiovascular risks during long-term follow-up, so cardiovascular safety is a critical factor that enhances a drug’s global competitiveness. The cardiovascular safety of Epeglenatide was proven in this large-scale clinical trial, enabling us to seek new innovations and business opportunities.”

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