Primary endpoint met at week 12
Innovent Biologics said its self-developed anti-PCSK9 monoclonal antibody SINTBILO, also known as tafolecimab injection, met the primary endpoint at week 12 in a Phase 3 monotherapy study in Chinese participants with non-familial hypercholesterolemia and mixed hyperlipidemia. The trial, CREDIT-5, was multi-center, randomized, double-blind and placebo-controlled, the company said.
SINTBILO is the first domestically developed PCSK9 antibody therapy commercialized in China and has been on the National Reimbursement Drug List since January 1, 2025, according to the company, which said the drug has reached more than 1 million patients.
The numbers from the study
At week 12, LDL-C fell 65.19% from baseline in the 150 mg every-two-weeks arm against 6.61% in the matching placebo arm, and 64.01% in the 450 mg every-four-weeks arm against 4.31% in its placebo arm, with a p value of < 0.0001 for both comparisons. A significant decrease was observed two weeks after the first dose.
The key secondary endpoints were also met, the company said: the proportion of participants reaching LDL-C < 2.6 mmol/L, LDL-C < 1.8 mmol/L and a reduction of at least 50% from baseline, plus the mean change in LDL-C, all with p values < 0.0001. Reductions in non-HDL-C, vLDL-C, ApoB and Lp(a) were larger than in the placebo groups, with Lp(a) down by nearly 50%.
Who was enrolled
A total of 198 participants were randomized 2:1:2:1 after a four-week run-in period during which lipid-lowering drugs were prohibited; 131 received tafolecimab and 67 received placebo. Mean baseline LDL-C was 3.7 mmol/L in the tafolecimab group and 3.8 mmol/L in the placebo group, and 61.1% and 53.7% respectively had mixed dyslipidemia at baseline.
Safety and the filing plans
No severe or serious treatment-emergent adverse events occurred, no adverse event led to discontinuation or interruption of the study drug, and no new safety signal was seen compared with earlier studies, according to Innovent. The company said it plans to submit a New Indication Application for SINTBILO to China's National Medical Products Administration in the near future.
