Sanofi will start phase 3 clinical trials of a long-lasting diabetes treatment candidate on Dec. 4, after bagging a license from Hanmi Pharmaceutical two years ago, according to registry disclosure site clinicaltrials.gov on Nov. 28.
The late-stage study will evaluate the efficacy and safety of efpeglenatide, a once-weekly glucagon-like peptide-1, in patients with type 2 diabetes inadequately controlled with diet and exercise. Sanofi plans to enroll 400 patients and complete the study by January 2020, its statement said.
“Uncertainties (surrounding efpeglenatide) have been resolved with the clinical trials registration,” Seo Keun-hee, an analyst at KB Securities said. Sanofi initially had planned to embark on the final-stage trials in 2016 but delayed the program as production of the drug fell behind schedule.
Shares of Hanmi Pharmaceutical increased 3.16 percent to 587,000 won (US$538.43) as of 11:30 a.m. Sanofi’s willingness and timetable to commence the study of efpeglenatide are being closely watched by investors as they witnessed a big drop in share price when the French firm returned rights to one of three new long-lasting diabetes treatment developed by Hanmi in December 2016.
In November 2015, the Korean drug maker licensed out three potential diabetes therapies -- efpeglenatide, a week-lasting insulin and a combination of efpeglenatide and LAPS-insulin115 -- to Sanofi.
To compete with rival products in the market, Sanofi needs to push efpeglenatide to be available for a wide range of therapeutic indications, according to Seo.
“In order to improve the commerciality, it should be prescribed for various patient groups,” she said.
She expected that Sanofi may test the drug with longer dose-free intervals to once-monthly and seek to prove its efficacy in weight loss as big pharma competitors are poised to or have already launched once-weekly GLP-1 diabetes medications.
Novo Nordisk is on track to win approval from the US Food and Drug Administration later this year to market its once-weekly type 2 diabetes treatment semaglutide while Eli Lilly’s rival product Trulicity is quickly increasing its market share.
By Park Han-na (email@example.com