Innovent Biologics, a leading biopharmaceutical firm, has revealed Phase-3 clinical trial outcomes of recombinant human anti-PCSK-9 monoclonal antibody in the patients with HeFH (heterozygous familial hypercholesterolemia) in China.

PCSK-9 inhibitors are known for strongly reducing LDL-C levels with a good protection profile and have been recognized gradually by clinicians as novel therapeutic regimens for some years.

While several imported PCSK-9 inhibitors are sold in the Chinese market, they have some limitations in terms of convenience and economy.

Moreover, IBI306 is a top leading drug developed independently by Innovent. It is a PCSK-9 inhibitor that is taking the lead in bringing out large-scale, randomized, long-term and double-blind phase III clinical studies in China (CREDIT-1, CREDIT-2 and CREDIT-4), and discovered and augmented the treatment routine with long-interval dosing.

The presentation of AAC 2022 is based on CREDIT-2, a double-blind, randomized and placebo-controlled phase 3 study assessing the safety and efficacy of IBI306 in Chinese patients with HeFH (heterozygous familial hypercholesterolemia).

The study results witnessed that IBI306 450 mg Q4W or 150 mg Q2W substantially reduced LDL-C levels in Chinese patients with HeFH.

Prof. Yujie Zhou, Vice President of Anzhen Hospital and principal investigator of CREDIT-2 study, stated that CREDIT-2 is the first phase 3 large-scale trial in China to demonstrate the safety and efficacy of PCSK-9 inhibitors in Chinese patients with HeFH.

IBI306, being a native innovative PCSK-9 inhibitor, can substantially decrease LDL-C and enhance other lipid limitations to an extent. As per the demonstration of comprehensive data, the IBI306 has essential therapeutic benefits, and it offers favorable safety to patients suffering from HeFH in China.

He further said that the university has confidence that this will be an alternate and accessible treatment option for patients of China with HeFH.

Source Credit - https://www.prnewswire.com/news-releases/innovent-releases-results-of-a-phase-3-clinical-study-of-ibi306-pcsk-9-inhibitor-in-chinese-patients-with-heterozygous-familial-hypercholesterolemia-at-the-american-college-of-cardiology-annual-congress-2022-301516245.html