China-based Innovent Biologics, Inc. (HKG: 1801) announced the results of the Phase III CREDIT-1 study for tafolecimab (IBI306), a recombinant fully human anti-PCSK-9 monoclonal antibody (mAb), in Chinese patients with non-familial hypercholesterolemia (non-FH). The findings were presented at the American Heart Association (AHA) Scientific Sessions 2022 as an e-poster (VP173).
Study Design and Results
CREDIT-1 is a randomized, double-blind, placebo-controlled Phase III clinical study (ClinicalTrials.gov, NCT04289285) designed to assess the efficacy and safety of tafolecimab in Chinese subjects with non-familial hypercholesterolemia. Patients on stable lipid-lowering therapies for at least four weeks were randomized 2:2:1:1 to receive 450 mg of subcutaneous tafolecimab every four weeks (Q4W), 600 mg of tafolecimab every six weeks (Q6W), or placebo Q4W or placebo Q6W for 48 weeks. The primary endpoint was the percent change from baseline to week 48 in LDL-C levels.
The results showed that compared with placebo, the treatment difference in mean change in LDL-C level from baseline to week 48 was -65% in the tafolecimab 450 mg Q4W group and -57.3% in the tafolecimab 600 mg Q6W group (both P < 0.0001).
Detailed Outcomes
- In the 450 mg Q4W group, 87.8% of subjects achieved ≥50% reduction in LDL-C levels from baseline to week 48; 91.7% achieved LDL-C <1.8 mmol/L; 83.4% achieved LDL-C <1.4 mmol/L.
- In the 600 mg Q6W group, 82.1% of subjects achieved LDL-C <1.8 mmol/L; 68.7% achieved LDL-C <1.4 mmol/L.
Additionally, significant reductions in non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), and lipoprotein(a) levels were observed with both dose regimens of tafolecimab versus placebo at week 48. Tafolecimab was well-tolerated, with a safety profile similar to other PCSK9 monoclonal antibodies.
Tafolecimab Profile
Developed by Innovent, IBI306 is an IgG2 fully human monoclonal antibody that specifically binds to PCSK-9, reducing LDL-C levels by inhibiting PCSK-9-mediated low-density lipoprotein receptor (LDLR) endocytosis and enhancing LDL-C clearance. Three pivotal trials for IBI306 have been completed, and the drug is awaiting regulatory decisions in China, with a market filing made in June this year for the treatment of primary hypercholesterolemia and mixed dyslipidemia.-Fineline Info & Tech
