Phase III CREDIT-1 study of IBI 306 in non-familial hypercholesterolemia presented at the American Heart Association (AHA) Scientific Sessions

A total of 618 subjects (baseline LDL-C level: 2.85mmol/L) were enrolled and 614 received at least one dose of the study treatment. Results show that both regimens of tafolecimab treatment induced significant reductions in LDL-C levels.

Compared with placebo, the treatment difference of mean change in LDL-C level from baseline to week 48 was –65.0% with tafolecimab 450 mg Q4W group and –57.3% with tafolecimab 600 mg Q6W group (both P < 0.0001). About the 450mg Q4W of the tafolecimab group: 87.8% of subjects receiving tafolecimab achieved at least 50% reduction from baseline to week 48 in LDL-C levels; 91.7% of subjects receiving tafolecimab achieved LDL-C <1.8 mmol l; 83.4% of subjects receiving tafolecimab achieved ldl-c><1.4 mmol l. about the 600mg q6w of the tafolecimab group: 82.1% of subjects receiving tafolecimab achieved ldl-c><1.8 mmol l; 68.7% of subjects receiving tafolecimab achieved ldl-c><1.4 mmol l. meanwhile, significant reductions in non-high-density lipoprotein cholesterol (non-hdl-c), apolipoprotein b (apob) and lipoprotein(a)lp(a) levels were achieved with both dose regimens of tafolecimab versus placebo at week 48. tafolecimab was well tolerated and the safety profile was similar to those of other pcsk9 monoclonal antibodies.

To conclude, tafolecimab administered at either 450 mg Q4W or 600 mg Q6W yielded significant and durable reductions in LDL-C levels and showed a favorable safety profile in Chinese patients with non-familial hypercholesterolemia. In June 2022, the China's National Medical Products Administration (NMPA) has formally accepted the New Drug Application (NDA) for tafolecimab injection for the treatment of primary hypercholesterolemia (including heterozygous familial hypercholesterolemia and non-familial hypercholesterolemia) and mixed dyslipidemia. Tafolecimab will potentially be the first approved locally-developed PCSK9 monoclonal antibody in China.

CREDIT-1 is a randomized, double-blind, placebo-controlled phase III clinical study (ClinicalTrials.gov, NCT04289285) to assess the efficacy and safety of tafolecimab in Chinese subjects with non-familial hypercholesterolemia. Patients on stable lipid-lowering therapies for at least 4 weeks were randomized 2:2:1:1 to receive subcutaneous tafolecimab 450 mg every 4 weeks (Q4W), tafolecimab 600 mg every 6 weeks (Q6W), placebo Q4W or placebo Q6W for 48 weeks. The primary endpoint was the percent change from baseline to week 48 in LDL-C levels.