Innovent’s PCSK-9 Antibody Meets Primary Endpoints in Two Phase 3 Studies

Innovent announced that IBI306, its PCSK-9 antibody, has met the primary endpoints of two Phase 3 trials in hypercholesterolemia, or high cholesterol. The Suzhou-based biopharma is laying down plans to submit a new drug application to the National Medical Products Administration (NMPA) this year. 

Lowering Cholesterol Levels 

Credit-1 and Credit-4 were the second and third registrational trials on IBI306 to meet their primary endpoints as of February 2022. Credit-1 assessed the drug in patients with non-familiar hypercholesterolemia (non-FH). The other study, Credit-4, assessed the drug in non-FH and heterozygous familial hypercholesterolemia (HeFH). 

In Credit-1, a 48-week treatment course of IBI306, dosed every four weeks at 450 mg, reduced levels of low-density lipoprotein cholesterol (LDL-C) by 65.04% versus placebo. A dose of 600 mg every 6 weeks saw reductions of 57.31% against placebo. 

In Credit-4, a 12-week treatment course of IBI306, dosed every four weeks at 450 mg, saw a statistically significant reductions of 63.02% from baseline. 

During both studies, IBI306 showed a similar safety profile to other marketed PCSK-9 inhibitors. 

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Hypercholesterolemia is Prevalent in China

Up to 26.3% of China’s population suffer from high blood cholesterol. Hypercholesterolemia increases the risk of atherosclerosis, heart disease and stroke. The condition is mainly treated with statins, but patients may not see considerable reductions in blood cholesterol, and long-term treatment may result in safety concerns. 

PCSK-9 inhibitors have been gaining attention for their ability to bring down blood cholesterol while maintaining a good safety profile. Two PCSK9 antibodies were approved by the USFDA in 2015: Praulent, developed by Sanofi and Regeneron, and Repatha by Amgen.

Repatha gained approval in China in 2018, while Praulent launched there in 2020. However, Innovent notes that available PCSK-9 inhibitors have “some limitations in terms of economy and convenience”, hinting at rollout issues gated by high prices. 

The company believes that IBI306 will provide a “friendlier and accessible treatment option for patients with hypercholesterolemia in China.”

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Joy Lin

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