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.
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