French drug giant Sanofi ($SNY) and U.S. biotech Regeneron ($REGN) have provided some impressive evidence that their antibody, dubbed REGN727, helps dramatically reduce levels of LDL cholesterol in multiple patient groups. The companies appear to be very much in the race among developers working on similar drugs that target the PCSK9 pathway.
In one of the midstage trials, the companies tested the drug in patients with high cholesterol and compared how it would impact their LDL, or "bad," cholesterol levels when they changed to higher doses of Pfizer's ($PFE) cholesterol drug Lipitor. Patients who got injections of REGN727 and 80 mg of Lipitor had a 65% drop in cholesterol versus a 17% reduction in patients on Lipitor alone after 8 weeks of therapy. There was also a 65% drop in cholesterol among patients who took REGN727 and only 10 mg of Lipitor.
In another Phase II, REGN727 was put to the test in patients with a genetic disorder that causes high cholesterol and whose LDL-C levels were elevated after they took lipid-lowering drugs. Regeneron and Sanofi's drug at various doses lowered LDL cholesterol levels from baseline 30% to more than 65% compared with only a 10% reduction in the placebo group.
"The preliminary Phase 2 results with our anti-PCSK9 antibody are very encouraging," Elias Zerhouni, Sanofi's president of global R&D, said in a statement. "We look forward to analyzing and presenting the complete data set and remain committed to advancing this program into Phase 3 development as soon as possible."
The companies obviously face the challenge of showing these types of compelling results in larger Phase III trials, but even midstage data like these garner lots of attention in part because of the blockbuster market for LDL-lowering drugs such as Lipitor. With Lipitor soon to lose exclusivity, relatively cheap knockoffs of the drug will enter the picture, and developers of new drugs will be under pressure to show big improvements in patients to gain market share. Sanofi and Regernon's drug also faces potential competition from PCSK9-targeted drugs under development at Amgen ($AMGN) and Pfizer ($PFE), Forbes reported.