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Clinical trial investigates new treatment for systolic heart failure patients

October 12, 2016

The academic partners in the VerICiguaT GlObal Study in Subjects with Heart Failure with Reduced EjectIon FrAction (VICTORIA) are pleased to announce that patient enrollment has begun. The study will explore a novel treatment pathway in patients suffering from chronic heart failure with reduced ejection fraction (HFrEF), by investigating the clinical impact of the drug vericiguat. VICTORIA is a pivotal Phase III clinical study conducted in collaboration with Merck (known as MSD outside the U.S. and Canada) and Bayer.

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. According to the American Heart Association, HF mortality is worse than some cancers, with approximately one third 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, MD, 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 standard of care HF therapy can help improve heart and vascular function, and reduce 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. Hence a critical unmet need exists for new treatments in patients with deteriorating HFrEF. Retarding or reversing the progression of disease and improving the current standard of care is a top priority," said Dr. Chris O'Connor, co-primary investigator of VICTORIA and Chief Executive Officer and Executive Director of Inova Heart and Vascular Institute. "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, administered at a dose of 10 mg, once daily, as 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 cardiovascular mortality or HF hospitalization, which is the composite endpoint of the trial. VICTORIA has a global reach and will enroll approximately 4,900 patients at more than 500 centres across 40 countries. It is anticipated that the study will take 39 months to complete. VICTORIA is conducted by Merck 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, presented at the 2015 American Heart Association (AHA) meeting in Orlando, Florida, and published in the Journal of the American Medical Association (JAMA). Dr. Burkert Pieske, co-chair of the phase II investigation and Co-Principal investigator of VICTORIA, Director of the Department of Internal Medicine and Cardiology, German Heart Institute and the Department of Internal Medicine and Cardiology at the Charité University Hospital in Berlin, said "We are excited that enrollment in our trial has now begun and we have the opportunity to evaluate vericiguat, the first sGC stimulator to be evaluated in patients with chronic HF. We can now carry forward our early promising results into this definitive phase III trial conducted around the globe."
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About Heart Failure

The prevalence of heart failure (HF) has increased progressively over the past several decades owing primarily to a reduction in myocardial infarction mortality and the aging of the world's population. Heart failure with reduced ejection fraction (HFrEF), also known as systolic heart failure, is characterized by the compromised ability of the heart to eject blood sufficiently during its contraction phase and represents the final common pathway for many cardiovascular diseases, including coronary artery disease. Once established, HFrEF progresses through activation of a variety of pathways that adversely affect cardiac structure and function. Currently, the most effective pharmacological therapies for HFrEF target the over-activation of the renin-angiotensin-aldosterone system and the adrenergic sympathetic nervous system that occurs in HF. However, even with the current treatment options, morbidity and mortality remain high and increase further after episodes of acute decompensation or HF hospitalization.

About Vericiguat

Vericiguat (BAY 1021189 / MK-1242), discovered at Bayer, is the first soluble guanylate cyclase (sGC) stimulator to be investigated as an oral once-daily in patients with deteriorating chronic heart failure. 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.

"We are especially pleased to have recruited an Executive Committee of world-wide thought leaders in heart failure who will provide inspired leadership and guidance for the trial along with leaders from both sponsors," said Paul Armstrong.

The development and commercialization of vericiguat is part of the worldwide strategic collaboration between Merck and Bayer in the field of sGC modulation. Merck is known as MSD outside the U.S. and Canada.

Executive Committee VICTORIA

Kevin Anstrom, Duke Clinical Research Institute (DCRI), USA
Paul Armstrong, Canadian VIGOUR Centre, University of Alberta, Canada
Javed Butler, Stony Brook Heart Institute, New York, USA
Justin Ezekowitz, Canadian VIGOUR Centre, University of Alberta, Canada
Adrian Hernandez, Duke Clinical Research Institute (DCRI), USA
Joerg Koglin, Merck CV Global Clinical Development
Carolyn Lam, National University Heart Centre, Singapore
Christopher O'Connor, Duke Clinical Research Institute (DCRI), Inova Heart and Vascular Institute, USA
Burkert Pieske, Charité University Medicine and German Heart Center, Berlin
Piotr Ponikowski, Medical University, Centre For Heart Disease, Wroclaw, Poland
Lothar Roessig, Bayer Global Clinical Development
Adriaan Voors, Groningen Heart Failure Research Institute, The Netherlands

University of Alberta Faculty of Medicine & Dentistry

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