Innovent Announces the Results of the Phase 1/2 Clinical Study of PCSK9 Antibody Tafolecimab at the European Society of Cardiology Annual Conference
SAN FRANCISCO and SUZHOU, China, Aug. 31, 2020 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent" or "the Company") (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, today announced that the Phase 1 (NCT03366688) and Phase 2 (NCT03815812) clinical study results of the recombinant fully human monoclonal antibody Tafolecimab (IBI306) were successfully presented in the 2020 European Society of Cardiology (ESC) annual conference (August 29 to September 1, Central European Summer Time) as e-Poster. This is the first time that domestic PCSK9 monoclonal antibody recognized by the international academic.
The accepted results were from CIBI306A101 and CIBI306B101, which demonstrated satisfactory safety and efficacy profiles of Tafolecimab. The incidence rates of treatment-emergent adverse events were comparable between Tafolecimab treated group and placebo treated group; Among all Tafolecimab treated subjects, LDL-C reductions were observed, which were (-52.2%, -72.1%) and (-54.30%, -72.26%) respectively in healthy subjects and hypercholesterolemia patients. Specially, compared with the marketed PCSK9 inhibitors, Tafolecimab preliminarily demonstrated longer dosing interval, which is 6 or even up to 8 weeks.
Prof. Yong Huo, the director of the Department of Cardiology at Peking University First Hospital and the leading PI of CIBI306B101 study, stated: "Tafolecimab, an innovative PCSK9 inhibitor developed locally with good safety and tolerability profile, can significantly reduce LDL-C levels according to current clinical study. This may provide more treatment options for Chinese patients with hypercholesterolemia, especially familial hypercholesterolemia patients and non-familial hypercholesterolemia patients with high/very high cardiovascular risks. The acceptance of this early phase clinical results from the ESC annual conference reflects the continuous improvement of innovative capacity of Chinese clinical research, which brings us with reputation in global academic field."
Professor Yimin Cui, director of the clinical trial center and the director the Institute of Pharmacology in Peking University First Hospital and the leading PI of CIBI306A101 study, stated: "Although statins are currently the first choice for lipid-lowering, and more and more new types of lipid-lowering drugs came to the market in recent years, many patients cannot achieve treatment standards because of drug efficacy and safety problems. With preferable efficacy and safety profile, PCSK9 inhibitors like Tafolecimab have attracted more and more attention focus in recent years. The study results of CIBI306A101/CIBI306B101 indicated a potential longer dosing interval of Tafolecimab compared with those imported drugs of the same type, which may bring more benefits to patients in need."
Dr. Michael Yu, Chairman and CEO of Innovent, stated: "Tafolecimab is an innovative drug independently developed by Innovent for the treatment of hypercholesterolemia. The acceptance of the results of this trial from the ESC Conference reflects the innovation and clinical application prospects of Tafolecimab. Currently, we are conducting three pivotal studies (CREDIT-1, CREDIT-2, CREDIT-3) of Tafolecimab, and hope to provide more personalized and convenient lipid-lowering options to doctors and patients in the near future."
Tafolecimab (IBI306) is a recombinant fully human monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9) developed by Innovent for the treatment of hypercholesterolemia. PCSK9 binds the LDL-R/LDL-C complex and prevents LDL-R dissociation, make it to degrade with LDL-C and thus cannot circulate back to the hepatic cell surface. As the amount of LDL-R expression on the cell surface decreases, the level of LDL-C in the blood will accumulate and increase.
Tafolecimab targets PCSK9 and inhibits its binding to LDL-R on the liver cell surface, maintaining the expression of LDL-R on the hepatocyte surface, thereby reducing LDL-C levels. Early phase clinical trials have preliminarily demonstrated that Tafolecimab has good safety, tolerability and efficacy. Moreover, it can be administered at longer intervals, thereby brings more convenient options to patients in need.
About CIBI306A101/CIBI306B101 study
IBI306A101 and IBI306B101 aims to investigate the safety, tolerability, recommended dose, PK/PD profile and the preliminary efficacy of Tafolecimab in healthy and patients hypercholesterolemia subjects.
Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of cancer, metabolic, autoimmune and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.
Since its inception, Innovent has developed a fully-integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 23 valuable assets in the fields of oncology, metabolic, autoimmune diseases and other major therapeutic areas, with 2 products, TYVYT® (sintilimab injection) and BYVASDA® (bevacizumab injection), on market, 2 assets under NDA review with priority review status, 4 assets in Phase 3 or pivotal clinical trials, and additional 15 molecules in or close to clinical trials. TYVYT® has been the only PD-1 inhibitor included in the NRDL since 2019.
Innovent has built an international team with expertise in cutting-edge biological drug development and commercialization, including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly, Adimab, Incyte, Alector, MD Anderson Cancer Center, Hanmi and other international partners. For more information, please visit: www.innoventbio.com.
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