AstraZeneca’s AZD0780 has demonstrated significant efficacy in a Phase IIb trial, showing a 50.7% reduction in LDL-C after 12 weeks when added to standard statin therapy.
The treatment helped 84% of participants reach the recommended LDL-C target, compared to just 13% with statins alone.
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The PURSUIT trial sought to compare the placebo to the company’s first oral small molecule modulator, designed for the treatment of dyslipidemia, when used alongside lipid-lowering statin therapy, the current standard of care in many cholesterol-related conditions.
The primary endpoint of the dose-finding trial sought to measure the effect of different doses of AZD0780 given once daily across differing levels of LDL-C in patients, with similar levels of efficacy observed regardless of whether patients had received moderate or high-intensity statin doses at the time of baseline measurement.
The therapy comes in response to research published in the journal Postgraduate Medicine that estimates as much as 70% of patients globally are currently not reaching guideline-recommended LDL-C targets.
The results were announced as part of the American College of Cardiology’s (ACC) Annual Scientific Expo in Chicago and suggest AZD0780 could provide a new, convenient option for patients struggling to meet cholesterol goals despite existing therapies.
The trial’s principal investigator Michael J Koren said: “The PURSUIT Phase IIb trial demonstrates the potential of AZD0780 to provide a much-needed once-daily oral treatment option to deliver greater LDL cholesterol lowering on top of standard of care for millions of patients who remain at risk for serious cardiovascular events, including premature death.
“These results are particularly important because the majority of patients with atherosclerotic disease today do not reach their LDL-C goals, despite the availability of lipid-lowering therapies such as statins and injectable PCSK9 inhibitors.”
Research by GlobalData estimates that should AZD0780 make it to market it is predicted to bring in $46m for AstraZeneca, with that figure forecasted to grow to $462m by the end of 2031.
GlobalData is the parent company of Clinical Trials Arena.
AstraZeneca’s executive vice president Sharon Barr said: “These new data reflect AZD0780’s ability to reduce LDL cholesterol in patients who need more options to manage their cholesterol and related risks when standard-of-care therapy is not enough.”
Elsewhere at the ACC Annual Expo, Cleerly has announced interim results from a trial, described as the largest-ever cardiovascular phenotype outcomes study, finding that women living with chronic coronary artery disease (CAD) are at higher risk of major adverse coronary events.
Meanwhile, Eli Lilly has reported promising Phase II results for lepodisiran, its experimental therapy aimed at reducing lipoprotein(a).
