A phase 3 trial of Bayer and Merck’s vericiguat in heart failure patients has met its primary endpoint. The top-line readout appears to justify the risk the partners took when they moved the stimulator of the soluble guanylate cyclase (sGC) enzyme into phase 3 despite missing the mark in an earlier trial.
Bayer and Merck put vericiguat through two phase 2 trials. One trial enrolled patients with chronic heart failure with reduced ejection fraction (HFrEF). The other study enrolled heart failure patients with preserved ejection fraction. Neither trial met its primary endpoint of change in N-terminal pro brain natriuretic peptide.
Despite the setback, Bayer and Merck enrolled 5,050 HFrEF patients in a phase 3 trial designed to show the effect of vericiguat on the the risk of cardiovascular death and hospitalization due to heart failure.
The partners will post numbers from the trial at a scientific meeting next year, but the details shared in a statement today paint the trial as a success. Vericiguat was better than placebo at extending the time to cardiovascular death or heart failure hospitalization, resulting in the clinical trial hitting its composite primary endpoint. The partners are yet to share other efficacy or safety findings.
Those as-yet-undisclosed details will shape the prospects of vericiguat. Competition for the HFrEF market is poised to heat up, with AstraZeneca, Boehringer Ingelheim and Eli Lilly working to bring drugs to market to challenge Novartis’ Entresto, which has grown into a blockbuster product since the FDA approved it in HFrEF in 2015.
Roy Baynes, head of global clinical development at Merck Research Laboratories, sees the design of the vericiguat phase 3 as one source of differentiation for the Bayer-partnered sGC modulator.
“VICTORIA is the first large contemporary outcomes study to focus exclusively on a population with worsening chronic heart failure who have a high risk for cardiovascular mortality and repeated heart failure hospitalizations,” Baynes said in a statement.