Sanofi announced Wednesday that it plans to conduct two phase 3 clinical trials related to Hanmi Pharmaceutical’s Efpeglenatide, a diabetes drug candidate, this year.
Efpeglenatide is a once-weekly Glucagon-like peptide-1 (GLP-1) receptor agonist for treating type-2 diabetes. The drug candidate was licensed out to Sanofi in 2015. Following the result of the two clinical trials, Sanofi plans to apply for sales approval in the U.S. by 2021.
One of phase 3 clinical trials to be added in the fourth quarter of this year is a combination therapy study of Efpeglenatide and basal insulin. The combination of the two mechanisms, along with positive blood glucose lowering effects, can offset the hypoglycemia and weight gain burdens that are disadvantages of insulin.
The company also plans to conduct additional phase 3 clinical trials that will compare the combination of Efpeglenatide and Metformin, an oral treatment that used in the treatment of type 2 diabetes, versus the compare drug Trulicity (Ingredient: Dulaglutide).
“A variety of clinical trials will be conducted to confirm the global competitiveness of Efpeglenatide,” Hanmi CEO Kwon Se-chang said. “The company plans to work closely with our partners to carry out U.S. Food and Drug Administration's application for sales approval in 2021 as planned.”