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.


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)