Hanmi announces positive phase 3 clinical trial results of its diabetes drug candidate
By Shim Woo-hyunPublished : June 29, 2021 - 17:29
Hanmi Pharmaceutical said Tuesday that efpeglenatide, its long-acting diabetes drug candidate, had significantly reduced the incidence of major adverse cardiovascular events and kidney disease, quoting the results of phase 3 clinical trials.
Sanofi, which has purchased the license for efpeglenatide from Hanmi, presented the results of the global, large-scale clinical trial at the American Diabetes Association’s 81st Scientific Sessions.
The phase 3 clinical trial involved 4,076 patients with Type 2 diabetes or cardiovascular disease across 344 regions in 28 countries. Sanofi administered 4 milligrams or 6 milligrams of efpeglenatide to patients on a weekly basis.
According to Sanofi, the long-acting diabetes drug reduced the incidence rates of major cardiovascular diseases by 27 percent and of kidney diseases by 32 percent in Type 2 diabetes patients, compared with a placebo.
The clinical study also showed that efpeglenatide safely reduced glucose, blood pressure and weight in the diabetes patients.
The study results have been published in the New England Journal of Medicine.
During the latest ADA event, Hanmi also presented the results of another phase 3 clinical study, which involved 406 Type 2 diabetes patients who had failed to control their blood sugar levels through diet and exercise.
The study said that Type 2 diabetes patients treated with efpeglenatide showed better blood sugar control and weight loss.
Hanmi also confirmed the efficacy of efpeglenatide in controlling blood sugar levels for an extended period. Efpeglenatide showed improvement in glycated hemoglobin levels in all dosage groups, over a 30-week treatment period. Those patients who received 4 mg and 6 mg dosages, in particular, showed significant improvement in glycated hemoglobin levels, the company added.
Efpeglenatide is a GLP-1 receptor agonist drug that Hanmi developed as a treatment for diabetes mellitus.
Hanmi licensed out the treatment to Sanofi in 2015, and Sanofi had funded clinical trials since then. However, Sanofi last year returned the marketing rights for the drug to Hanmi after announcing a dramatic shift away from its long-term focus on diabetes and CV care.