Hanah Abercrombie / U.S. Air Force / Public domain / Archive laboratory blood testing, April 2019, resized; not the Innovent trial
Innovent Biologics said its cholesterol medicine Sintbilo met the main goal in a Phase 3 trial testing it as a stand-alone treatment, and the company plans to seek a new indication in China.
The CREDIT-5 study enrolled 198 Chinese adults with non-familial hypercholesterolemia or mixed hyperlipidemia, Innovent said in its Sunday company announcement. The multicenter trial was randomized, double-blind and placebo-controlled. Its primary endpoint was the percentage change in LDL cholesterol from baseline after 12 weeks.
Participants receiving 150 milligrams of Sintbilo every two weeks had a mean LDL-C reduction of 65.19%, compared with a 6.61% reduction in the matching placebo group. Those receiving 450 milligrams every four weeks had a reduction of 64.01%, compared with 4.31% for the matching placebo group. The company reported p-values below 0.0001 for both comparisons.
Those percentages are changes from each group’s baseline cholesterol levels, not placebo-adjusted reductions. Across the study, 131 participants received the medicine and 67 received placebo, following a four-week run-in period during which lipid-lowering drugs and products were prohibited.
Innovent said there were no severe or serious treatment-emergent adverse events, no adverse events leading to discontinuation or interruption of the study medicine, and no new safety signal compared with previous studies. Those safety findings are the company’s account of this trial, rather than a guarantee about all patients or longer-term use.
Sintbilo, also called tafolecimab, is an antibody targeting PCSK9. According to Innovent, it is already approved in China for adults with primary hypercholesterolemia, including heterozygous familial and non-familial forms, and mixed dyslipidemia.
The company plans to submit a new-indication application to China’s National Medical Products Administration. Sunday’s announcement reported trial findings and a planned filing, not a new regulatory approval.
CREDIT-5’s main measurement was cholesterol reduction. The results do not establish that the treatment reduced heart attacks or deaths in this study.
JBizNews Desk | Suzhou, China
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