Obicetrapib

The Phase III BROOKLYN trial presented at AHA 2024 showed obicetrapib significantly reduced LDL cholesterol by 41.5% at 365 days, with 34% of patients achieving >50% reduction. Obicetrapib also lowered Lp(a) by 54.3%, addressing unmet need in dyslipidemia treatment.

NewAmsterdam Pharma announced additional Phase 3 BROOKLYN trial results for obicetrapib, showing significant LDL-C, Lp(a), and LDL particle reductions in HeFH patients on maximally tolerated lipid-lowering therapy, with safety comparable to placebo.

Innovation in prevention and global implementation, vascular outcomes, novel trials for heart failure, targeted therapies for cardiomyopathies, AF management, cardiovascular interventional outcomes, incretin modulation, and advances in lipid therapeutics were discussed at the event, featuring various randomized trials and clinical studies.

Bio-pharma advances in endocrinology, dermatology, cardiovascular, oncology, rare diseases, pulmonology, gastroenterology, and neurology highlight promising therapies like Eli Lilly’s orforglipron, Amgen’s MariTide, Novo Nordisk’s oral semaglutide, Johnson & Johnson’s JNJ-2113, Sanofi’s amlitelimab, Ionis’s olezarsen, BridgeBio’s acoramidis, NewAmsterdam Pharma’s obicetrapib, Jazz Pharmaceuticals’ zanidatamab, Syndax’s revumenib, Merus’ zenocutuzumab, Johnson & Johnson’s nipocalimab, Novo Nordisk’s Mim8, Solid Biosciences’ SGT-003, Merck’s sotatercept, Johnson & Johnson’s Tremfya, and Crossject’s Zepizure, with analyses including clinical data, revenue forecasts, and expected launch dates.

At ESC 2024, Dr. Erin Michos discussed the success of obicetrapib trials, showing its ability to reduce LDL. Completion of Phase III TANDEM trial enrollment brings NewAmsterdam closer to launching obicetrapib for HeFH/ASCVD. If successful, it could offer a new treatment for high cholesterol, addressing the unmet need for Lp(a) reduction.

Positive topline data from Phase 3 BROOKLYN trial shows obicetrapib significantly reduces LDL-C by 36.3% at 12 weeks and 41.5% at 52 weeks in HeFH patients, with well-tolerated safety profile. Over 50% achieved LDL-C below 70 mg/dl, and reductions in non-HDL-C, ApoB, and Lp(a) were statistically significant. The trial evaluated 10 mg obicetrapib vs. placebo in 354 patients with HeFH on maximally tolerated lipid-lowering therapy.

NewAmsterdam Pharma updates on obicetrapib's Phase 3 trials: BROOKLYN (HeFH) data expected 3Q 2024, BROADWAY (ASCVD) 4Q 2024, and PREVAIL CVOT enrollment completion 1Q 2024 with data in 2026. Plans to start TANDEM trial (obicetrapib + ezetimibe) 1Q 2024, data expected 1Q 2025. Well-funded through 2026.