(Reuters) – French drugmaker Sanofi SA said it and partner Regeneron Pharmaceuticals Inc have begun enrolling more than 20,000 patients for late-stage trials of their cholesterol fighter REGN727 and hope the medicine will be approved by late 2015.
The injectable drug works by blocking PCSK9, a naturally occurring protein that coaxes the body to retain LDL cholesterol.
In small earlier trials, REGN727 slashed LDL levels by 40% to 70% without any serious side effects. That is comparable to the largest LDL reductions typically seen with statins.
REGN727 would be geared to patients who cannot tolerate statins, as well as to millions of others who do not get their LDL levels down to target levels with statins.
“The studies could allow us to have a global launch in 2016, but our goal is for the first launch by the fourth quarter of 2015,” Jay Edelberg, head of Sanofi’s development program for REGN727, said in an interview.
Other drugmakers, including Merck & Co and Amgen Inc, are racing to develop their own PCSK9 inhibitors, spurred in part by stellar results seen in earlier small mid-stage trials of REGN727.
Roche Holding AG also has an anti-PCSK9 drug in development, known as RG7652, that is due to enter phase III trials in 2013, according to a recent article in an internal Roche newsletter.
Edelberg said patients in phase III studies of REGN727 would receive injections every two weeks. Most will take it in combination with statins. It will also be tested in separate trials among patients who cannot tolerate statins, as well as in patients with familial hypercholesterolemia.
“Only a few hundred patients have been enrolled, but we hope to roll out all the studies this year,” he said.
Edleberg said one of the phase III trials will test the safety of REGN727 over an extended period, while another especially long study will evaluate the drug’s potential to reduce the incidence of heart attacks and other cardiovascular problems.