Innovent PCSK9 monoclonal antibody reaches the end point of Phase 3 clinical trial and plans to launch

On February 17, Innovent announced that two key registration clinical studies in China of the company's self-developed recombinant fully human anti-proprotein convertase subtilisin 9 (PCSK-9) monoclonal antibody (R&D code: IBI306)— —CREDIT-1 study (treatment of non-familial hypercholesterolemia [non-FH] with high/very high cardiovascular risk) and CREDIT-4 study (treatment of non-familial hypercholesterolemia type of familial hypercholesterolemia [HeFH]), all met the primary endpoint of the study

Up to now, the three major key registration clinical studies of IBI306 have all been completed and have successfully reached the primary study endpoints, of which the CREDIT-2 study (treatment of heterozygous familial hypercholesterolemia [HeFH]) has reached the clinical stage in August 2021.

IBI306 is an innovative biological drug independently developed by Innovent Biopharmaceuticals.

To date, three registered clinical studies of IBI306 have met their primary endpoints

The CREDIT-1 study is a randomized, double-blind, placebo-controlled Phase III clinical trial evaluating the efficacy and safety of IBI306 in Chinese patients with non-familial hypercholesterolemia (hypercholesterolemia with high/very high risk cardiovascular risk) study (ClinicalTrials.

The results of the CREDIT-1 study showed that in Chinese non-familial hypercholesterolemia (non-FH) patients with high-risk/very high-risk cardiovascular risk, after 48 weeks of continuous treatment with each dose group of IBI306, low-density lipoprotein cholesterol (LDL- C) Compared with the baseline reduction level, there was a significant improvement compared with the placebo group (450 mg Q4W group: the least squares estimated between-group difference was -65.

The CREDIT-4 study is a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of IBI306 in Chinese patients with hypercholesterolemia (including non-familial hypercholesterolemia and heterozygous familial hypercholesterolemia).

The results of the CREDIT-4 study showed that in Chinese non-FH and HeFH patients, the relative baseline reduction of LDL-C after 12 weeks of IBI306 treatment was also significantly improved compared with the placebo group (450 mg Q4W group The least squares estimated between-group difference was - 63.

The CREDIT-2 study is a randomized, double-blind, placebo-controlled Phase III clinical study evaluating the efficacy and safety of IBI306 in Chinese heterozygous familial hypercholesterolemia subjects (ClinicalTrials.

The CREDIT-2 study showed that after 12 weeks of continuous treatment with IBI306 in Chinese heterozygous familial hypercholesterolemia patients receiving statin and/or ezetimibe, LDL cholesterol ( LDL-C) levels were significantly improved

Hypercholesterolemia is an independent risk factor for cardiovascular diseases such as atherosclerosis, coronary heart disease, and stroke, which seriously threatens people's health.

PCSK-9 inhibitors are gradually recognized by clinicians as a new treatment plan that can effectively reduce LDL-C levels and have good safety in recent years.

(Original abridged)