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Doctors await Novartis Lp(a) trial details after pelacarsen miss
Reuters reported Monday that cardiologists are waiting for Saturday's American Heart Association presentation of Novartis and Ionis's pelacarsen trial, which missed its main cardiovascular endpoint despite lowering lipoprotein(a).
- New headline Was: “Novartis heart drug failure leaves doctors seeking evidence for genetic cholesterol target”
- Our desk filed its story
Based on reporting by Reuters
Cardiologists and investors are waiting for full results of a large Novartis Phase 3 trial of pelacarsen, an experimental drug meant to lower lipoprotein(a), after the company said the study missed its main goal of cutting a composite of death, heart attack, stroke and procedures to restore blood flow, Reuters reported Monday1.
Pelacarsen, developed with Ionis Pharmaceuticals, had been shown to cut blood Lp(a) by about 80 percent, Reuters said, without a matching drop in heart-attack and stroke risk in the trial1. About one in five people carry genes that raise production of the particle, which is not changed by diet or exercise, the report said, with higher incidence among people of African or South Asian ancestry1.
Detailed results are due Saturday in Chicago at the American Heart Association scientific meeting, Reuters said, where doctors will look at whether the miss was narrow, null, or in the wrong direction1. Dr. Parag Joshi of UT Southwestern Medical Center, an investigator on the study, told Reuters, "If there are no signals at all, then that will really dampen any further enthusiasm for the space"1.
Reuters said rival Lp(a) drugs from Amgen and Eli Lilly have shown larger reductions in earlier tests, with Phase 3 readouts expected in 2028 and 2029, and that those trials enroll patients with higher Lp(a) than many in the Novartis study1. Novartis declined further comment, Reuters said, and trial lead Dr. Steven Nissen of Cleveland Clinic said he could not speak before the presentation1. Doctors cited possible design issues, including stroke in the composite endpoint, a monthly 80 milligram dose not fully tested in midstage work, and background use of potent LDL-lowering drugs1.
