Bayer announced that the first patient was enrolled in VICTORIA, a pivotal phase III clinical study led by Bayer’s collaboration partner MSD, which will investigate vericiguat in patients suffering from chronic heart failure with reduced ejection fraction (HFrEF). Vericiguat, discovered at Bayer, is the first soluble guanylate cyclase (sGC) stimulator to be evaluated in patients with deteriorating chronic heart failure.
The development and commercialization of vericiguat is part of the worldwide strategic collaboration between Bayer and MSD (through a subsidiary) in the field of sGC modulation. MSD is known under the name of Merck in the US and Canada.
Heart failure (HF) is a serious debilitating condition that is characterized by the progressive decline in the heart’s ability to pump enough blood through the body. The global burden of HF is increasing, and the mortality rate remains high. In fact, HF mortality is worse than some cancers, with between 17% and 45% of patients dying within one year of hospitalization for an acute HF event.
“Despite available treatment options, the prognosis for HFrEF patients remains poor, and we need new treatment options,” said Paul W. Armstrong, M.D., Founding Director of the Canadian VIGOUR Centre and Distinguished Professor at the University of Alberta, and Chair of the study’s Executive Committee. “The VICTORIA study is designed to assess whether the addition of vericiguat on top of best standard of care HF therapy can help restore a vital cardiovascular pathway, thereby improving heart and vascular function and reducing the risk of cardiovascular death or HF hospitalization in patients with deteriorating chronic HF with reduced ejection fraction.”
“Currently, one in five people worldwide are expected to develop HF in their lifetime. With the novel compound vericiguat, Bayer and MSD are pursuing a new research approach in this field," said Dr. Jörg Möller, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Development. “We are excited about vericiguat being the first sGC stimulator to be evaluated in patients with chronic HF.”
“There is a critical need for new treatments, especially for patients with deteriorating HFrEF that slow the progression of disease and improve the standard of care,” said Dan Bloomfield, M.D., Vice President, Cardiovascular Diseases, The research labs of Merck & Co., Inc., Kenilworth, NJ, USA. “The VICTORIA phase III program will help us determine if vericiguat could have a role in the future of HF treatment in this high-risk population.”
The event-driven phase III VICTORIA study will assess the efficacy and safety of vericiguat up to 10 mg once daily compared to placebo (on background standard of care treatment) in reducing the risk of cardiovascular death or HF hospitalization in patients with HFrEF following HF hospitalization or receiving an intravenous diuretic without hospitalization. The primary efficacy outcome is the time to first occurrence of the composite endpoint of cardiovascular mortality or HF hospitalization. VICTORIA will enroll approximately 4,900 patients at 530 centres in 39 countries and it is anticipated that the study will take 39 months to complete. VICTORIA is conducted in partnership with the Canadian VIGOUR Centre (CVC) at the University of Alberta and the Duke Clinical Research Institute (DCRI).
The design and dosing of the phase III VICTORIA study was informed by results from the SOCRATES-REDUCED phase II trial in 456 patients with HFrEF, which were presented at the 2015 annual meeting of the American Heart Association (AHA) in Orlando, Florida and published in the Journal of the American Medical Association (JAMA).
Vericiguat (BAY 1021189 / MK-1242) is an investigational, oral once-daily stimulator of the soluble guanylate cyclase (sGC) enzyme. While sGC is important for the function of both the blood vessels and the heart, it is insufficiently stimulated in heart failure patients due to impaired nitric oxide (NO) availability resulting in systemic vascular and coronary dysfunction. The sGC pathway is being investigated as a potential therapeutic target for the treatment of heart failure, with vericiguat being the first sGC-stimulator under development in this indication.
Since October 2014, the worldwide strategic collaboration with the US-based company MSD (known as Merck in the US and Canada) in the field of sGC modulators brings together the two leading companies in this field, who both have the stated intent to make full use of this investigational class of compounds and the potential it may hold for the benefit of patients. As part of the collaboration, the vericiguat program is being co-developed by Bayer and MSD. While MSD is taking the lead on the phase III VICTORIA study, the companies are equal partners and funders in the development and commercialization of vericiguat. For vericiguat, MSD has the commercial rights for the Americas and Bayer has the commercial rights to the rest of the world.