Tafolecimab monotherapy reduced low-density lipoprotein cholesterol by more than 60% at week 12 in phase 3 CREDIT-5 results

1. Tafolecimab monotherapy reduced low-density lipoprotein cholesterol (LDL-C) by 65.19% with 150 mg every 2 weeks (Q2W) and 64.01% with 450 mg every 4 weeks (Q4W) at week 12, versus placebo.

2. The study met its secondary lipid endpoints, with no severe or serious treatment-emergent adverse events, adverse-event-related discontinuations or new safety signals reported.

Evidence Rating Level: 2 (Good)

2MM Brief: Innovent Biologics reported topline results from CREDIT-5, a phase 3 study evaluating tafolecimab monotherapy for Chinese participants with non-familial hypercholesterolemia and mixed hyperlipidemia. The multi-center, randomized, double-blind, placebo-controlled study enrolled 198 participants after a 4-week run-in period during which lipid-lowering drugs or products were prohibited. Participants were randomized in a 2:1:2:1 ratio to subcutaneous tafolecimab 150 mg Q2W, placebo Q2W, tafolecimab 450 mg Q4W, or placebo Q4W. The primary endpoint was the percent change in LDL-C from baseline at week 12. At week 12, LDL-C decreased by 65.19% with tafolecimab 150 mg Q2W versus 6.61% with placebo Q2W, and by 64.01% with tafolecimab 450 mg Q4W versus 4.31% with placebo Q4W; both comparisons had P<0.0001. The company reported that the prespecified secondary endpoints were also met: the proportions of participants reaching LDL-C levels below 2.6 mmol/L or below 1.8 mmol/L, the proportion achieving at least a 50% LDL-C reduction, and mean LDL-C change were all higher with tafolecimab than with the corresponding placebo groups, with all between-group P values <0.0001. Reductions in non-high-density lipoprotein cholesterol (non-HDL-C), very-low-density lipoprotein cholesterol (vLDL-C), apolipoprotein B (ApoB) and lipoprotein(a) (Lp(a)), among other lipid measures, were also greater with tafolecimab. No severe or serious treatment-emergent adverse event (AE) (TEAE) occurred, no adverse event led to study-drug discontinuation or interruption, and no new safety signal was observed. The results have not been peer reviewed, and the release did not report confidence intervals or detailed event counts. As topline results from one company-reported trial, CREDIT-5 supports tafolecimab monotherapy as an LDL-C-lowering treatment in this studied population, while longer-term clinical outcomes and the full safety and efficacy findings remain to be established.

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