Published : Nov. 28, 2017 - 14:04
Sanofi will start next month phase 3 clinical trials of efpeglenatide -- a diabetes drug candidate licensed from South Korea’s Hanmi Pharmaceutical two years ago, the companies said Tuesday.
The phase 3 trials for efpeglenatide, to be conducted on 400 patients with Type II diabetes, will start in the US on Dec. 4, according to updated postings by Sanofi on ClincalTrials.gov. Sanofi plans to complete the study by January 2020.
Hanmi Pharmaceutical's headquarters located in Jamsil of southeastern Seoul (Hanmi Pharmaceutical)
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.
The start of final-stage trials of efpeglenatide comes as competitive products are on the way, most notably Novo Nordisk’s weekly injectable GLP-1 treatment semaglutide. The drug received a positive recommendation approval from the US Food and Drug Administration in October.
Semaglutide is also under review by the European Medicines Agency and Japanese Pharmaceuticals and Medical Devices Agency.
Local analysts said that Sanofi may seek to conduct additional tests showing that the drug candidate can be administered in longer intervals -- once monthly instead of once weekly -- to give its drug a competitive edge over other existing GLP-1 treatments in the market.
By Sohn Ji-young (
jys@heraldcorp.com)