Innovent Presents Results of IBI306 in P-III (CREDIT-2) Study for the Treatment of Heterozygous Familial Hypercholesterolemia at ACC 2022
Shots:
- The P-III (CREDIT-2) study evaluates IBI306 (150mg, q2w, 450mg, q4w) vs PBO in a ratio (2:1:2:1) in 148 patients with HeFH
- The results showed that patients with both IBI306 (150mg, q2w, 450mg, q4w) achieved a reduction in LDL-C levels. The 2EPs showed ≥50% LDL-C reductions @12wks. (58.5% for 150mg, q2w) & (73.4 for 450mg, q4w), reduced Lp (a) levels (-43.3% & −34.1%), multiple improvements including LDL-C < 1.8 mmol/L response rate, non-HDL-C, ApoB & other Lipid parameters after 12wks.
- LDL-C reduction was well maintained at ≥50% @24wks. & the safety profile was similar to other marketed PCSK-9 inhibitors. The company plans to submit an NDA in 2022 & will meet with regulatory authorities to benefit the Chinese patients
Ref: PR Newswire | Image: Innovent
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