- The first patient has been enrolled in a pivotal Phase 3 clinical trial,VICTORIA, assessing Bayer's (OTCPK:BAYRY) vericiguat for the treatment of patients with chronic heart failure with reduced ejection fraction (HFrEF). The study is being led by collaboration partner Merck (NYSE:MRK).
- VICTORIA will involve ~4,900 subjects and take three years to complete. It will assess the safety and efficacy of up to 10 mg of vericiguat once daily compared to placebo (on a background of standard-of-care treatment) in reducing the risk of cardiovascular (CV) death or hospitalization due to heart failure(HF) in HFrEF patients following HF hospitalization or an intravenous diuretic without hospitalization. The primary endpoint is the time to first occurrence of the composite endpoint of CV mortality or HF hospitalization.
- Vericiguat, discovered at Bayer, is a soluble guanylate cyclase (sGC) stimulator. Guanylate cyclase is a key enzyme in the nitric oxide (NO) signaling pathway which promotes vasodilation while inhibiting smooth muscle proliferation, leukocyte recruitment, platelet aggregation and modulating inflammation. The agents are being developed to treat hypertension and chronic obstructive pulmonary disease in addition to heart failure.
- Vericiguat is being co-developed by the two companies under their October 2014 strategic collaboration. Funding for development and commercialization are being shared equally. Merck has commercial rights in the Americas and Bayer elsewhere.
- About 20% of people worldwide will develop HF in their lifetime.