Sanofi launches five P3 clinical trials for Hanmi’s diabetic drug

Lee Han-soo  Published 2018.12.14  15:17  Updated 2018.12.14 15:17


Hanmi Pharmaceutical said Friday that Sanofi, its global partner for efpeglenatide, a new diabetes drug candidate, has managed to add two more phase 3 trials.

With the two new trials, there are now 6,400 patients participating in five types of research globally. Sanofi plans to complete all clinical trials by the end of the first half of 2021.

Efpeglenatide is a long-acting glucagon-like peptide-1 (GLP-1) biological treatment for diabetes. In 2015, Sanofi obtained a license from Hanmi and had since been conducting multiple phase-3 trials simultaneously around the world.

One of the two clinical trials that Sanofi has recently announced will compare the efficacy of efpeglenatide or placebo on 640 diabetic patients, who witnessed little to no effect while taking a monotherapy of metformin, a broad-spectrum oral diabetic drug) or combination treatment with the drug and sulfonylurea (oral diabetic drug).

Sanofi plans to administer the drug once a week for 30 weeks to compare drug safety with blood glucose and weight control.

The other study will compare the dose efficacy on 400 patients with type 2 diabetes who did not have sufficient blood glucose control, either alone with basal insulin or in combination with an oral diabetic medication, with efpeglenatide or placebo.

The company will compare efpeglenatide and placebo for 56 weeks by administering the drugs once a week to confirm the drug’s safety, blood glucose, and weight control.

“Simultaneous multiple clinical trials for rapid commercialization and the new drug value for efpeglenatide is proceeding smoothly,” Hanmi Pharmaceutical’s President-CEO Kwon Se-chang said. “The company will do its best to work closely with its partners to dramatically improve the quality of life for patients suffering from the disease.”

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