Sanofi starts remaining phase 3 clinical trials of Hanmi’s diabetes drug candidate

By Sohn Ji-young

Published : Dec 14, 2018 - 14:21
Updated : Dec 14, 2018 - 14:21

South Korea’s Hanmi Pharmaceutical said Friday that Sanofi has signaled the start of two new phase 3 clinical studies of the Type 2 diabetes drug candidate efpeglenatide by officially listing the plans on ClinicalTrials.gov, a US-based clinical trials registry site.

By doing so, Sanofi has officially executed all five of its planned phase 3 clinical trial agenda for efpeglenatide, which Hanmi licensed out to Sanofi in 2015, according to the Korean drugmaker.

So far, Sanofi has been carrying out three phase 3 clinical studies -- one to discern the effect of efpeglenatide on cardiovascular outcomes, another to compare the drug’s efficacy to a placebo and another to compare efpeglenatide with Dulaglutide.

Hanmi Pharmaceutical’s headquarters in southeastern Seoul (Hanmi Pharmaceutical)


Now, two types of new clinical trials have begun. One study aims to compare efpeglenatide’s efficacy and safety in treating type 2 diabetes that is inadequately controlled with metformin alone or in combination with sulfonylurea.

The other study compares the diabetes drug candidate’s efficacy and safety in treating type 2 diabetes that is inadequately controlled with basal insulin alone or in combination with an oral antidiabetic drug.

Around 6,400 patients will participate in the five Sanofi-led efpeglenatide studies, which will conclude in the first half of 2021, according to the companies.

Developed by South Korea’s Hanmi Pharmaceutical, efpeglenatide is a once-weekly GLP-1 receptor agonist for treating Type II diabetes. The drug candidate was licensed out to Sanofi in November 2015.

Efpeglenatide employs Hanmi’s Lapscovery -- short for Long Acting Protein and Peptide Discovery -- delivery technology, which extends the life of a peptide or protein in the body, extending efficacy and potency.

By Sohn Ji-young (jys@heraldcorp.com)

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The Korea Herald by Herald Corporation