American College of Cardiology’s 69th Annual Scientific Session with World Congress of Cardiology (ACC.20/WCC Virtual) – March 28-30, 2020

Company Product Description Indication Status
Astrazeneca plc, of Cambridge, U.K. Farxiga (dapagliflozin propanediol) Sodium glucose transporter-2 inhibitor Heart failure with reduced ejection fraction Subanalysis of phase III Dapa-HF trial showed Farxiga reduced incidence of primary composite endpoint of heart failure worsening or cardiovascular death vs. placebo
Astrazeneca plc, of Cambridge, U.K. Brilinta (ticagrelor) P2Y12 purinoceptor antagonist Coronary artery disease Subanalysis of independent phase IV Twilight-DM study in individuals with diabetes who underwent successful percutaneous coronary intervention (PCI) showed Brilinta monotherapy associated with 35% lower risk of primary outcome of bleeding event and similar risk of ischemic events vs. dual antiplatelet therapy (DAPT) of aspirin plus Brilinta; subanalysis of phase IV Twilight-Complex study in those who underwent successful complex PCI showed Brilinta monotherapy had 46% lower risk of bleeding and similar risk of ischemic events vs. DAPT 
Cytokinetics Inc., of South San Francisco Omecamtiv mecarbil Myosin stimulator Cardiac failure Baseline characteristics from phase III Galactic-HF study that enrolled 8,256 participants showed average age was 65, with 79% male and 78% white; 55% had ischemic heart disease and 36% had chronic kidney disease; 87% were on ACE inhibitor or similar therapy, 94% were on beta-blocker and 77% were on MRA; top-line data expected in fourth quarter of 2020
Esperion Therapeutics Inc., of Ann Arbor, Mich., and Daiichi Sankyo Europe GmbH, unit of Daiichi Sankyo Co. Ltd., of Tokyo Bempedoic acid + ezetimibe (Nexlizet) ATP citrate lyase inhibitor; AMP activated protein kinase stimulator Hypercholesterolemia Phase II fixed-dose combination study with ezetimibe showed 40% reduction in LDL-C vs. placebo and 25% reduction in high-sensitivity C-reactive protein compared to baseline for those with type 2 diabetes at high risk of cardiovascular events, with no increase in hemoglobin A1c
Esperion Therapeutics Inc., of Ann Arbor, Mich., and Daiichi Sankyo Europe GmbH, unit of Daiichi Sankyo Co. Ltd., of Tokyo Bempedoic acid (Nexletol) ATP citrate lyase inhibitor Hypercholesterolemia Pooled analysis of 4 phase III trials in 3,600+ adults with hypercholesterolemia showed lowering of LDL-C and other lipid endpoints regardless of presence of background ezetimibe; second pooled analysis showed high sensitivity C-reactive protein was reduced by 42% at 12 weeks in those with hypercholesterolemia, regardless of presence or intensity of background statins
Janssen Pharmaceutical Inc., unit of Johnson & Johnson, of New Brunswick, N.J. Xarelto (rivaroxaban) Factor Xa antagonist Peripheral artery disease Phase III Voyager PAD combination study with aspirin met primary efficacy and safety endpoints, showing study drug at 2.5 mg twice daily plus aspirin at 100 mg once daily was superior to aspirin alone, reducing risk of major adverse limb and cardiovascular events by 15% at 3 years in symptomatic PAD after lower-extremity revascularization (17.3% vs. 19.9%, respectively; p=0.009), with similar rates of major bleeding (2.65% vs. 1.87%, respectively; p=0.07)
Janssen Pharmaceutical Inc., unit of Johnson & Johnson, of New Brunswick, N.J. Xarelto (rivaroxaban) Factor Xa antagonist Coronary or peripheral artery disease Subanalysis of phase III Compass trial assessing Xarelto 2.5 mg twice daily plus aspirin 100 mg vs. placebo plus aspirin 100 mg in 10,341 participants with diabetes and 17,054 without diabetes showed composite primary efficacy endpoint (cardiovascular death, myocardial infarction or stroke) occurred in 8.4% of those with diabetes on study drug vs. 10.7% in placebo group (p=0.002); in those without diabetes, 5.8% on Xarelto experienced primary endpoint event vs. 7.2% in placebo group (p=0.005)
Kiniksa Pharmaceuticals Ltd., of Hamilton, Bermuda Rilonacept Dual interleukin-1 alpha/beta ligand inhibitor Pericarditis Supplemental analysis from phase II trial showed corticosteroid-failure patients with active pericarditis who received study drug had rapid and sustained reductions in pericarditis pain and C-reactive protein (CRP) and tapered or discontinued corticosteroids without recurrence of disease; corticosteroid-dependent patients on drug tapered or discontinued corticosteroids without pericarditis recurrence, and colchicine-failure patients with active pericarditis on drug had rapid and sustained reductions in pain and CRP
Merck & Co. Inc., of Kenilworth, N.J. Vericiguat Guanylate cyclase stimulator Chronic heart failure Phase III Victoria trial showed study drug in combination with available heart failure therapies vs. placebo met primary efficacy endpoint of reducing risk for composite endpoint of heart failure hospitalization or cardiovascular death in those with worsening chronic heart failure with reduced ejection fraction
Mesoblast Ltd., of Sydney Revascor (rexlemestrocel-L) Allogeneic mesenchymal precursor cell therapy Ischemic heart failure Substudy of 70 patients with end-stage disease and left ventricular assist device (LVAD) showed mean proportion of temporary weans from LVAD support was higher with Revascor vs. saline control (64% vs 43%); rate of mucosal bleeding was lower (4.2 vs 28/100 patient-months, respectively); fewer readmissions occurred (0.59 vs. 1.14/100 patient-days, respectively)
Novartis AG, of Basel, Switzerland Inclisiran PCSK9 gene inhibitor Hypercholesterolemia Pooled data from phase III Orion-9, -10 and -11 trials showed inclisiran reduced LDL-C by 51% at 17 months when used with other lipid-lowering therapies; prespecified exploratory analysis based on safety reporting from trials showed fewer major adverse cardiovascular events vs. placebo (7.1% vs. 9.4%, respectively)
Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. Evinacumab  Fully human monoclonal antibody targeting ANGPTL3 Homozygous familial hypercholesterolemia Detailed phase III results showed patients who added evinacumab to other lipid-lowering therapies reduced their LDL-C by 49% from baseline at 24 weeks vs. the placebo group, who received other lipid-lowering therapies alone, the primary endpoint(p<0.0001); nearly half of evinacumab-treated patients reduced LDL-C to under 100 mg/dL (nominal p=0.0203), despite entering the trial with average LDL-C levels of 260 mg/dL on other lipid-lowering therapies 

Notes

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