Innovent reports positive Phase 3 results for tafolecimab monotherapy

The randomized, double-blind, placebo-controlled study enrolled 198 participants, assigned in a 2:1:2:1 ratio to receive tafolecimab 150 mg every two weeks, placebo every two weeks, tafolecimab 450 mg every four weeks, or placebo every four weeks. Lipid-lowering drugs and products were prohibited during a four-week run-in period.

At week 12, LDL-C had fallen 65.19% in the 150 mg group and 64.01% in the 450 mg group. The corresponding placebo reductions were 6.61% and 4.31%; between-group differences were statistically significant, with p-values below 0.0001. Innovent said the LDL-C reduction was significant two weeks after the first dose. Key secondary endpoints—including reaching LDL-C levels below 2.6 mmol/L or 1.8 mmol/L and achieving at least a 50% reduction—also favored tafolecimab, with p-values below 0.0001.

The company reported greater reductions than placebo in non-HDL-C, the TC/HDL-C ratio, vLDL-C, ApoB, the ApoB/ApoA1 ratio and Lp(a); Lp(a) fell by nearly 50%. Innovent said the treatment had a favorable safety and tolerability profile, with no severe or serious treatment-emergent adverse events, no adverse events leading to study-drug discontinuation or interruption, and no new safety signals.

SINTBILO is a fully human PCSK9 monoclonal antibody already approved in China for adults with primary hypercholesterolemia, including heterozygous familial and non-familial forms, and mixed dyslipidemia. Innovent said the drug has been included in China’s National Reimbursement Drug List since January 1, 2025, and has benefited more than 1 million patients. The company plans to submit a new indication application to the National Medical Products Administration. Trial results do not, by themselves, establish that the new use has been approved.