Date: 2014-04-01
Type of
information: Results
phase: 2
Announcement: results
Company: Sanofi (France) Regeneron Pharmaceuticals (USA - NY)
Product: alirocumab (SAR236553/REGN727)
Action
mechanism:
- monoclonal antibody/PCSK9 inhibitor.Alirocumab (SAR236553/REGN727) is a subcutaneously administered, fully-human antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) in clinical development. By inhibiting PCSK9, a determinant of circulating LDL-cholesterol levels in the blood, REGN727 increases the number of free LDL receptors which can bind to circulating LDL and clear it from the bloodstream. REGN727 was created using Regeneron's VelocImmune® technology and is being developed by Regeneron in collaboration with Sanofi.
Disease: patients with primary hypercholesterolemia with elevated LDL-C
Therapeutic
area: Cardiovascular diseases
Country: Japan
Trial
details: This multicenter, placebo-controlled Phase 2 study randomized approximately 100 patients with LDL-C greater than or equal to 100 mg/dL receiving lipid-modifying therapy. 25 patients per group were randomized to receive one of three doses of alirocumab dosed subcutaneously every other week (Q2W) -- 150 milligrams (mg), 75 mg or 50 mg, or placebo, all in combination with statin therapy. The primary study endpoint was the percentage change in calculated LDL-C from baseline to Week 12. The secondary study endpoints included absolute change in calculated LDL-C from baseline to Week 12 and percent and absolute changes in other lipid parameters at Week 12.
Latest
news:
- • On April 1, 2014, Sanofi and Regeneron have announced that the first Phase 2 study with alirocumab, in Japanese patients met its primary endpoint. The results demonstrated that the mean low-density lipoprotein-cholesterol (LDL-C, or "bad" cholesterol) percentage reduction from baseline to week 12, the primary efficacy endpoint of the study, was significantly greater in patients randomized to receive one of three doses of alirocumab administered every other week (Q2W) -- 150 milligrams (mg), 75 mg, and 50 mg, in combination with statin therapy, compared to patients receiving placebo. At Week 12, the mean percentage reduction in LDL-C from baseline in patients receiving alirocumab 50 mg Q2W was 55 percent, alirocumab 75 mg Q2W was 62 percent and alirocumab 150 mg Q2W was 72 percent, compared to 3 percent in the placebo group (p < 0.0001 vs. placebo for all treatment arms). All patients in each of the alirocumab groups achieved LDL-C levels of < 100 mg/dL, compared to 8 percent of patients in the placebo group.
- Treatment emergent adverse events (TEAEs) in this study were reported by 52 percent of patients in the alirocumab 50 mg group, 48 percent of patients in the 75 mg group, 64 percent of patients in the 150 mg group, compared to 32 percent in the placebo group. The most frequently reported TEAEs were nasopharyngitis, injection site reaction, back pain, cystitis and ligament sprain.
Is
general: Yes
