Cardiovascular Drug Development Faces Major Setbacks and Upcoming Milestones

BioSpace reports on a turbulent period for cardiovascular drug development, highlighted by a series of late-stage clinical trial failures. According to Oppenheimer analysts, the sector experienced six clinical failures within nine weeks. Notable setbacks include Novo Nordisk's IL-6 inhibitor ziltivekimab, which failed to reduce cardiovascular risks, and Novartis's antisense therapy pelacarsen, which lowered Lp(a) levels without generating clinical benefit. Additionally, AstraZeneca and Ionis Pharmaceuticals reported a disappointing Phase 3 result for their TTR silencer Wainua.

Despite these challenges, the sector has seen positive developments. The FDA approved Eli Lilly's Mounjaro to lower cardiovascular risks in type 2 diabetes patients, and Merck secured approval for an oral PCSK9 inhibitor. Furthermore, early-stage trials showed promising results for Verve's base editor VERVE-102 in lowering LDL cholesterol.

Looking ahead, the fourth quarter brings critical readouts. NewAmsterdam Pharma anticipates Phase 3 data for its CETP inhibitor obicetrapib, while Johnson & Johnson and Bristol Myers Squibb await results from a Phase 3 trial of the oral Factor XIa inhibitor milvexian for secondary stroke prevention.