Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, announces today that the primary endpoint was met in the phase 3 study CREDIT-2 of recombinant fully human anti-PCSK-9 monoclonal antibody (R&D code: IBI306, independently developed by Innovent) for the treatment of Chinese heterozygous familial hypercholesterolemia (HeFH).
The analysis showed that after 12 weeks of continuous treatment with IBI306 in Chinese patients with heterozygous familial hypercholesterolemia who have been previously treated with statins and/or ezetimibe, their low-density lipoprotein cholesterol (LDL-C) levels were significantly reduced compared with the placebo arm. Throughout the study, IBI306 demonstrates a favorable safety profile, similar to the reported safety profiles of other marketed PCSK-9 inhibitors.
The principal investigator of the CREDIT-2 study, Prof. Yujie Zhou, Vice President of Anzhen Hospital, from the Capital Medical University stated, "Although the prevalence of familial hypercholesterolemia is relatively low, due to the large population in China, the absolute number of patients still ranks among the highest in the world. Heterozygous patients often progress rapidly with an early onset, resulting in the significant increase of the serum total cholesterol (TC) and low density lipoprotein (LDL-C) levels. Patients may experience severe atherosclerotic cardiovascular disease (ASCVD) or even death in early and middle ages. Recently, PCSK-9 inhibitors, as a new class of effective therapy to treat familial hypercholesterolemia, have been recommended by the US, EU and China guidelines. Although there are imported PCSK-9 inhibitors on the China market, there is a lack of evidence in Chinese heterozygous familial hypercholesterolemia. We are very pleased to announce that as one of the key registration studies of a Chinese innovative anti-PCSK-9 monoclonal antibody IBI306, CREDIT-2 has met its primary endpoint. For the first time, Chinese researchers have confirmed that anti-PCSK-9 monoclonal antibody can significantly reduce LDL-C levels with an overall favorable safety profile in such patient population through a randomized, double-blind, controlled study. This study provides new high-quality clinical evidence for the treatment of Chinese heterozygous familial hypercholesterolemia population."
Dr. Lei Qian, Executive Director of Medical Sciences and Strategies of Special Diseases of Innovent, stated: " There remains a great unmet medical need in Chinese patients with heterozygous familial hypercholesterolemia. As a novel PCSK-9 inhibitor developed by Innovent with independent intellectual property rights, previous study results showed that IBI306 could effectively reduce TC and LDL-C levels in patients with hypercholesterolemia, and the success of CREDIT-2 further validated the efficacy of IBI306 and was also a key step in the registration of IBI306. We hope to provide clinicians with an effective, safe, and more accessible treatment option through innovative development strategies and solid research design, so as to achieve the goal of benefiting more patients with hypercholesterolemia. I am confident and looking forward to the results of other pivotal registrational studies of IBI306."
About CREDIT-2 study
The CREDIT-2 study is a randomized, double-blind, placebo-controlled phase 3 study to evaluate the efficacy and safety of IBI306 in Chinese subjects with heterozygous familial hypercholesterolemia (ClinicalTrials.gov, NCT04759534). A total of 148 eligible patients were enrolled. The primary efficacy endpoint was the percentage reduction from baseline in LDL-C after 12-week treatment.
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