Innovent Biologics has reported a major clinical milestone for its cholesterol-lowering drug SINTBILO (tafolecimab injection).

 

This was after the treatment met the primary endpoint in a Phase 3 trial, demonstrating more than 60% reductions in LDL cholesterol (LDL-C) when used as a standalone therapy.

 

Results from the CREDIT-5 study showed that the drug reduced LDL-C levels by 65.19% with the 150 mg every-two-weeks regimen and 64.01% with the 450 mg every-four-weeks regimen after 12 weeks of treatment. The reductions were significantly greater than those recorded in the placebo groups, with both comparisons achieving p-values below 0.0001.

 

The findings strengthen the case for tafolecimab as a potential first-line monotherapy option for patients with non-familial hypercholesterolemia and mixed hyperlipidemia, particularly those who cannot tolerate statins or do not achieve adequate cholesterol control with existing treatments.

 

Innovent said it plans to submit a New Indication Application to China's National Medical Products Administration (NMPA) in the near future, potentially expanding the drug's use among patients requiring standalone lipid-lowering treatment.

 

The multicentre, randomised, double-blind, placebo-controlled Phase 3 trial enrolled 198 Chinese participants. Of these, 131 received tafolecimab, while 67 received placebo. Participants were assigned to one of two dosing schedules or corresponding placebo regimens following a four-week run-in period during which lipid-lowering drugs and products were prohibited.

 

The trial met not only its primary endpoint but also all key secondary endpoints. Patients receiving tafolecimab were significantly more likely than those receiving placebo to achieve LDL-C levels below 2.6 mmol/L and 1.8 mmol/L, as well as reductions of at least 50% from baseline.

 

The drug also demonstrated a rapid response, with significant LDL-C reductions observed just two weeks after the first dose.

 

Beyond LDL cholesterol, tafolecimab delivered improvements across several other important lipid indicators, including non-HDL-C, total cholesterol-to-HDL-C ratio, very-low-density lipoprotein cholesterol (VLDL-C), apolipoprotein B (ApoB) and lipoprotein(a) [Lp(a)]. Lp(a) levels fell by nearly 50%, according to the study results.

 

These findings point to the drug's potential to address multiple lipid-related risk factors associated with atherosclerotic cardiovascular disease (ASCVD), although the trial did not establish a reduction in cardiovascular events.

 

Safety results were also encouraging. Innovent reported favourable safety and tolerability, with no severe or serious treatment-emergent adverse events, no adverse events leading to treatment discontinuation or interruption, and no new safety signals compared with earlier studies.

 

Professor Yida Tang of Peking University Third Hospital, the study's lead principal investigator, said the results address an important gap in cholesterol management, particularly for patients who cannot rely on statins.

 

"For a long time, statins have been the first-line standard of care for hypercholesterolemia. However, some patients still suffer from poor efficacy of statin monotherapy or combination therapy due to statin intolerance, insufficient long-term medication compliance, etc. Therefore, there is an urgent clinical need for more non-statin monotherapy options with sufficient evidence-based evidence. 

 

"This Phase 3 clinical study met the primary and secondary endpoints, confirming that for patients with non-familial hypercholesterolemia and mixed hyperlipidemia, tafolecimab monotherapy can bring clinically significant reductions in LDL-C and improve lipid-related risk factors of ASCVD, without the need for combination therapy with statins. 

 

"This not only further validates the therapeutic value of PCSK9 monoclonal antibody as an independent lipid-lowering regimen, but also provides new clinical evidence for patients and clinicians who need non-statin treatment. It is expected to expand the options for individualized treatment of hyperlipidemia, help more patients achieve effective control of blood lipids, and better meet the challenges of long-term blood lipid management."

 

Lei Qian, Innovent's Chief R&D Officer (General Biomedicine), said the findings reinforce the company's efforts to expand treatment options for patients with hyperlipidemia.

 

"As the first innovative drug in Innovent's general biomedicine portfolio to receive regulatory approval and be included in China's NRDL, SINTBILO has been developed with a strong focus on addressing the unmet medical needs of patients with hyperlipidemia. 

 

"This Phase 3 clinical study further demonstrated the therapeutic value of SINTBILO in achieving significant lipid-lowering as monotherapy, providing robust clinical evidence for treatment of hyperlipidemia. We will continue to work closely with clinical experts to accelerate the translation of research findings into clinical practice, so that more patients can benefit from innovative therapist, contributing to improved long-term management of hyperlipidemia in China."

 

The trial results come amid a substantial and growing dyslipidemia burden in China. National survey data from 2020 to 2022 put the prevalence of dyslipidemia among Chinese adults aged 18 and above at 38.1%.

 

Despite the widespread use of statins as the foundation of cholesterol-lowering treatment, awareness, treatment and control rates remain low. Patients who fail to achieve their cholesterol targets may require additional therapies, including cholesterol absorption inhibitors or PCSK9 inhibitors.

 

PCSK9 inhibitors work by preventing the degradation of low-density lipoprotein receptors (LDLR), enabling the liver to clear more LDL cholesterol from the bloodstream. Tafolecimab is a fully human IgG2 monoclonal antibody that specifically targets PCSK9.

 

Innovent said the treatment has benefited more than one million patients since its launch and has been recommended in multiple Chinese clinical guidelines and expert consensus statements.