Merck and Bayer Launch New Phase 3 Trial of First-in-Class sGC Stimulator Verquvo (vericiguat) for Earlier Treatment in Chronic Heart Failure

November 12, 2021 /BioValleyBIOON/ -- MSD (Merck & Co) recently announced the launch of the VICTOR trial (NCT05093933), a pivotal, randomized, placebo-controlled, cardiovascular Phase 3Clinical Trial, will evaluate the efficacy and safety of Verquvo (vericiguat) in patients with chronic heart failure with reduced ejection fraction. The studyPatients enrolled were those with chronic heart failure, a recent absence of worsening heart failure events, and an ejection fraction ≤40%.

Currently, patient recruitment for the VICTOR trial has begun. The study plans to enroll approximately 6,000 adult patients with chronic heart failure with reduced ejection fraction who have not been hospitalized for heart failure for 6 months or received outpatient intravenous diuretic therapy within 3 months prior to randomization. The primary efficacy endpoint is the time to the first occurrence of a cardiovascular death event or hospitalization due to heart failure.

The VICTOR trial will evaluate the earlier use of Verquvo in the course of heart failure in certain patients.The study focuses on a more stable population of chronic heart failure patients than those in the pivotal Phase 3 VICTORIA trial.。VICTORIA is the first contemporary outcomes study specifically targeting symptomatic chronic heart failure patients (ejection fraction <45%) following a worsening event., based on the results of this study, Verquvo has been approved in the United States, Japan, and the European Union.

Verquvo is taken orally once daily. Its active pharmaceutical ingredient, vericiguat, is a first-in-class soluble guanylate cyclase (sGC) stimulator. Although sGC is crucial for the function of blood vessels and the heart, in patients with heart failure, sGC stimulation is insufficient due to impaired availability of nitric oxide (NO), leading to myocardial and vascular dysfunction. Vericiguat is co-developed by MSD andBayerJointly developed, the two parties reached a global collaboration in October 2014 to develop sGC modulators. MSD has the commercial rights to vericiguat in the United States, and Bayer holds exclusive rights in the rest of the world.

Verquvo is the first soluble guanylate cyclase (sGC) stimulator approved for the treatment of heart failure.. In January this year, Verquvo was approved in the United States,For symptomatic chronic heart failure patients with an ejection fraction <45%, to reduce the risk of cardiovascular death and heart failure hospitalization following a worsening heart failure event (defined as: hospitalization for heart failure or treatment of heart failure with outpatient intravenous [IV] diuretics without hospitalization).In June this year, Verquvo was approved in Japan for the treatment of patients with chronic heart failure (CHF) who are receiving standard CHF therapy, to reduce the risk of further worsening events. Currently, vericiguat is also under review in China and other countries.In China, Bayer submitted the marketing authorization application for vericiguat to the National Medical Products Administration (NMPA) at the end of August 2020.

Verquvo's mechanism of action is different from existing heart failure treatments, offering a unique approach to managing chronic heart failure patients who have experienced one episode of decompensation (also known as a worsening event). Current therapies block the harmful effects of natural neurohormonal systems, which are activated by myocardial and vascular dysfunction that occur in heart failure. Verquvo works synergistically with existing treatments through a distinct mode of action, specifically restoring the defective NO-sGC-cGMP pathway, which plays a key role in the progression of heart failure and the exacerbation of disease symptoms.

Patients with symptomatic chronic heart failure and reduced ejection fraction are at high risk of hospitalization after experiencing heart failure symptoms that require outpatient intravenous diuretic therapy or inpatient treatment. It is estimated that more than half of the patients are readmitted within one month post-discharge due to worsening conditions, and approximately one-fifth of patients die within two years. After vericiguat becomes available on the market, it will provide a welcome new option for physicians, healthcare professionals, and patients.

The regulatory approval of Verquvo is based on the results of the pivotal Phase 3 VICTORIA study. This is the first contemporary outcomes study specifically targeting symptomatic chronic heart failure patients (ejection fraction <45%) following a worsening event. The data shows,When combined with available heart failure medications, a once-daily 10mg dose of vericiguat significantly reduced the relative risk of the composite endpoint of heart failure hospitalization and cardiovascular death after a worsening event by 10% compared to placebo (HR=0.90; 95% CI: 0.82-0.98; p=0.019), with an absolute risk reduction of 4.2 per 100 patient-years.. (Bioon.com)

Source of the original text:Merck Announces Initiation of Phase 3 Study Evaluating VERQUVO® (vericiguat) in Patients with Chronic Heart Failure and Reduced Ejection Fraction Who Have Not Had a Recent Worsening Heart Failure Event