Merck to Present Cardio-Pulmonary Pipeline Data at ACC.26, Including Phase 3 Enlicitide Results
Merck will present late-breaking clinical data from its cardio-pulmonary pipeline at ACC.26, including positive Phase 3 results for enlicitide, an investigational oral PCSK9 inhibitor, and Phase 2 data for WINREVAIR in heart failure patients.
Merck announced new clinical data from the company's cardio-pulmonary pipeline will be presented at the American College of Cardiology's Annual Scientific Session and Expo (ACC.26) in New Orleans, La., from March 28-30. The presentations will include two late-breaking trials: positive results from the Phase 3 CORALreef AddOn trial evaluating enlicitide, an investigational, once-daily oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, and positive results from the Phase 2 CADENCE trial evaluating WINREVAIR™ (sotatercept-csrk) in adults with CpcPH-HFpEF.
The Phase 3 CORALreef AddOn trial evaluated the efficacy and safety of enlicitide versus ezetimibe, versus bempedoic acid and versus ezetimibe and bempedoic acid in adults with hypercholesterolemia who are treated with a statin. The trial results will be presented on Monday, March 30, at 11:45 a.m. ET/10:45 a.m. CT. Enlicitide has the potential to be the first approved oral PCSK9 inhibitor. It is designed to lower LDL-C via the same biological mechanism as currently approved monoclonal antibody, injectable PCSK9 inhibitors but in a daily pill form. Enlicitide is an investigational novel macrocyclic peptide.
The Phase 2 CADENCE trial evaluated WINREVAIR™ (sotatercept-csrk) in adults with the syndrome of combined post- and precapillary pulmonary hypertension and heart failure with preserved ejection fraction (CpcPH-HFpEF). The results will be presented as a late-breaking presentation on Sunday, March 29, at 12:00 p.m. ET/11:00 a.m. CT.
Additional presentations at ACC.26 will include data on the durability of enlicitide for lipid lowering from an on-treatment analysis of data from CORALreef Lipids and CORALreef HeFH trials, scheduled for Sunday, March 29, at 1:35 p.m. ET/12:35 p.m. CT. A Phase 1 update showing that the novel oral PCSK9 inhibitor enlicitide does not affect the pharmacokinetics of narrow therapeutic index concomitant medications will be presented on Saturday, March 28, at 10:30 a.m. ET/9:30 a.m. CT.
The company will also present research on lipid-lowering therapy patterns, including a systematic review showing women are less likely than men to receive add-on nonstatin lipid-lowering therapy (LLT) and to adhere to LLT, and findings from the LISTEN-LDL-US study on patient survey data regarding treatment experiences and needs in the United States. Additional abstracts will cover the association between LDL-C lowering and reduced risk of cardiovascular events through an updated systemic review and meta-regression, and patient characteristics and outcomes by atherosclerotic cardiovascular disease phenotype using real-world data from England.
The senior vice president, head of general and specialty medicine, global clinical development, Merck Research Laboratories stated that the data planned for presentation at ACC will underscore the strength and momentum of Merck's cardio-pulmonary pipeline as the company works to advance research that helps address the CV epidemic impacting millions with atherosclerosis, as well as CpcPH-HFpEF, a distinct syndrome with limited treatment options.