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SAN FRANCISCO and SUZHOU, China, April 3, 2022 /PRNewswire/ — Innovent Biologics, Inc. (Innovent) (HKEX: 01801), 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 that the results of a phase 3 clinical trial (Study code: CREDIT-2) of recombinant full-human anti-PCSK-9 monoclonal antibody (R&D code: IBI306, independently developed by Innovent) in Chinese patients with heterozygous familial hypercholesterolemia (HeFH) have been accepted as an abstract presented (E-poster #: 1188-005) at the American College of Cardiology Annual Congress 2022 (ACC 2022).
PCSK-9 inhibitors, which can potently reduce LDL-C levels with a good safety profile, have been gradually recognized by clinicians as novel therapeutic regimens in recent years. Although there are various imported PCSK-9 inhibitors marketed in the Chinese market, there are some limitations in terms of economy and convenience. IBI306 is an innovative drug independently developed by Innovent. It is the PCSK-9 inhibitor that take the lead in carrying out long-term, large-scale, randomized and double-blind phase III clinical studies in China (CREDIT-1, CREDIT-2 and CREDIT-4), and explored and optimized the treatment regimen with long-interval dosing.
The AAC 2022 presentation is based on CREDIT-2, a randomized, double-blind, placebo-controlled phase 3 study, evaluating the efficacy and safety of IBI306 in Chinese patients with heterozygous familial hypercholesterolemia (ClinicalTrials.gov, NCT04179669). During the 12 -week double-blind treatment period, patients previously received a stable lipid-lowering therapy for at least 4 weeks were randomized 2:1:2:1 to receive subcutaneous injection of IBI306 or placebo 150 mg Q2W, or IBI306 or placebo 450 mg Q4W respectively. In week 12-24, patients in control groups continued to receive IBI306 with the previous regimens; while patients in placebo groups were crossed over to receive open-label IBI306 150 mg Q2W or 450 mg Q4W, respectively. The primary endpoint was the percent change in LDL-C levels from baseline to week 12.
The results of study showed that both IBI306 150 mg Q2W or 450 mg Q4W yielded significant reduction in LDL-C levels in Chinese patients with HeFH. As for the Primary endpoint: IBI306 significantly reduced LDL-C levels (treatment difference versus placebo: −57.4 % [97.5% CI, −69.2% to −45.5%] for 150 mg Q2W; −61.9% [−73.4% to −50.4%] for 450 mg Q4W; P<0 0001 for both comparisons). And for the key secondary endpoint: significantly more patients treated with IBI306 achieved ≥50% LDL-C reductions at week 12 as compared with corresponding placebo groups (58.5% [97.5% CI, 42.2% to 74.8%] for 150 mg Q2W; 73.4% [58.5% to 88.4%] for 450 mg Q4W; P<0 0001 for both comparisons). IBI306 significantly reduced Lp(a) levels (treatment difference versus placebo: -43.3% [95% CI, −58.9% to -27.6%] for 150 mg Q2W; −34.1% [−47.1% to −21.1%] for 450 mg Q4W; P<0 0001 for both comparisons). In addition, IBI306 treatment induced various improvements including LDL-C < 1.8 mmol/L response rate, non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB) and other Lipid parameters after 12 weeks of treatment. At the same time, the LDL-C reduction in the IBI306 groups was well maintained at 50% and above throughout 24 weeks. The overall safety profile of IBI306 in the study was favorable and similar to the safety profile of other marketed PCSK-9 inhibitors.
Prof. Yujie Zhouprincipal investigator of CREDIT-2 study and Vice President of Anzhen Hospital, from the …
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