Tafolecimab significantly reduces LDL-C, confirms Phase 1/2 Clinical Study
Tafolecimab, an innovative PCSK9 inhibitor developed locally with good safety and tolerability profile, can significantly reduce LDL-C, find phase 1/2 clinical trial.
SAN FRANCISCO and SUZHOU, China - Researchers have announced Phase 1 (NCT03366688) and Phase 2 (NCT03815812) clinical study results of the recombinant fully human monoclonal antibody Tafolecimab (IBI306) which 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.The results depicted that Tafolecimab, an innovative PCSK9 inhibitor developed locally with good safety and tolerability profile, can significantly reduce LDL-C.
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."
