Merck/Bayer set to challenge Novartis in heart failure after phase 3 trial success

Merck & Co and Bayer’s heart failure drug vericiguat has hit its target in a phase 3 trial, vindicating a decision by the big US pharma to buy into the project for $1 billion.

The big US pharma bought US rights to vericiguat more than three years ago, with the companies setting their sights on a competitor to Novartis’ Entresto, a blockbuster that generated $430 million in Q3 alone with sales up 61%.

The companies are jointly developing the soluble guanylate cyclase (sGC) stimulator, and in 2016 took a gamble by pushing it into phase 3 development despite mixed results at phase 2.

Only the highest dose – 10 mg – produced a benefit in the phase 2 SOCRATES-REDUCED trial by significantly reducing a biomarker called N-terminal pro-B-type natriuretic peptide.

After positive phase 3 results from the VICTORIA trial, it looks like Bayer and Merck could give Novartis a run for its money.

VICTORIA met its composite primary endpoint when vericiguat reduced risk of heart failure hospitalisation or cardiovascular death in patients with worsening chronic heart failure with reduced ejection fraction, when added to available heart failure therapies and compared with placebo.

Further details of findings of the large trial involving 5,050 patients will be announced at a medical meeting next year.

Secondary endpoints include time to occurrence of cardiovascular death, time to first occurrence of heart failure hospitalisation, time to total heart failure hospitalisations (including first and recurrent events), time to the composite of all-cause mortality or heart failure hospitalisation, and time to all-cause mortality.

Merck and Bayer are also trialling vericiguat in heart failure with ejection fraction at phase 2 – an indication where Novartis' Entresto surprisingly flopped in a phase 3 trial in August.

Novartis has insisted that the bulk of the evidence for Entresto in the PARAGON-HF trial shows “clinically important benefits” in this poorly served form of heart failure for which there are no specifically approved therapies.