Data from the 24-hour open-label portion of the HELP (Hemodynamic Evaluation of Levosimendan in PH-HFpEF) Study will be presented during the American Heart Association (AHA) Scientific Sessions 2020.

The phase 2 HELP Study enrolled patients with pulmonary hypertension and heart failure with preserved ejection fraction and was designed to evaluate levosimendan’s hemodynamic and clinical effects during rest and exercise. The initial phase of the trial was open-label and designed to identify patients who elicited a hemodynamic response following a 24-hour infusion of levosimendan. Patients who met the prespecified response criteria of ≥4 mmHg reduction in pulmonary capillary wedge pressure during supine bicycle exercise were deemed to be responders and were randomized to a 6-week double-blind placebo-controlled phase of the trial.

The 24-hour HELP Study results being presented at AHA include data from a total of 44 patients, of which 36 (~85%) were determined to be responders. Details regarding the presentation are as follows:

Title: 24-hour Levosimendan Infusion Decreases Biventricular Filling Pressures at Rest and Exercise in PH-HFpEF
Author: Daniel Burkhoff, MD PhD, Director Heart Failure, Hemodynamics and MCS Research at the Cardiovascular Research Foundation., et al
Session: Novel Translational Insights for Pulmonary Vascular and RV Remodeling
Date/Time: Available OnDemand beginning Friday, November 13, 2020 at 9:00 a.m. CST

About Phase 2 HELP Trial

The HELP Study (Hemodynamic Evaluation of Levosimendan in PH-HFpEF) was a multi-center, double-blind, placebo-controlled Phase 2 clinical trial designed to evaluate levosimendan in 36 patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). Endpoints in the trial evaluated various invasive hemodynamic and clinical measures including a 6-minute walk test. The Company previously announced positive topline results from this Phase 2 trial. The trial demonstrated significant reduction in right atrial and pulmonary capillary wedge pressures. It also demonstrated a significant improvement with 6-minute walk distance.