{"id":24584,"date":"2022-11-07T01:01:00","date_gmt":"2022-11-06T17:01:00","guid":{"rendered":"https:\/\/flcube.com\/?p=24584"},"modified":"2025-02-01T01:05:22","modified_gmt":"2025-01-31T17:05:22","slug":"innovent-biologics-tafolecimab-shows-strong-ldl-c-reduction-in-phase-iii-study","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=24584","title":{"rendered":"Innovent Biologics’ Tafolecimab Shows Strong LDL-C Reduction in Phase III Study"},"content":{"rendered":"\n

China-based Innovent Biologics, Inc. (HKG: 1801<\/a>) announced the results of the Phase III CREDIT-1 study for tafolecimab (IBI306), a recombinant fully human anti-PCSK-9 monoclonal antibody (mAb), in Chinese patients with non-familial hypercholesterolemia (non-FH). The findings were presented at the American Heart Association (AHA) Scientific Sessions 2022 as an e-poster (VP173).<\/p>\n\n\n\n

Study Design and Results<\/strong>
CREDIT-1 is a randomized, double-blind, placebo-controlled Phase III clinical study (ClinicalTrials.gov, NCT04289285) designed to assess the efficacy and safety of tafolecimab in Chinese subjects with non-familial hypercholesterolemia. Patients on stable lipid-lowering therapies for at least four weeks were randomized 2:2:1:1 to receive 450 mg of subcutaneous tafolecimab every four weeks (Q4W), 600 mg of tafolecimab every six weeks (Q6W), or placebo Q4W or placebo Q6W for 48 weeks. The primary endpoint was the percent change from baseline to week 48 in LDL-C levels.<\/p>\n\n\n\n

The results showed that compared with placebo, the treatment difference in mean change in LDL-C level from baseline to week 48 was -65% in the tafolecimab 450 mg Q4W group and -57.3% in the tafolecimab 600 mg Q6W group (both P < 0.0001).<\/p>\n\n\n\n

Detailed Outcomes<\/strong><\/p>\n\n\n\n