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Debiopharm and Sigma-tau report positive Phase II results of heart failure drug

Debiopharm Group and Sigma-tau Industrie Farmaceutiche Riunite have reported positive efficacy results of a Phase IIa Horizon-HF study with Debio 0614, also known as istaroxime, in development for the treatment of acute heart failure.

The data showed that Debio 0614 is able to significantly reduce pulmonary congestion in patients admitted with worsening heart failure and left ventricular dysfunction. The results of the study also demonstrated that in patients with decompensated heart failure, Debio 0614 improves hemodynamics and diastolic function, without adversely affecting neurohormones or renal function.

Paolo Carminati, R&D director of sigma-tau, said: “Compared to available inotropes, known to be associated with increase of heart rate, hypotension and increase in atrial or ventricular arrhythmias, Debio 0614 demonstrated a rapid improvement of pulmonary capillary wedge pressure, associated with an apparent increase in systolic blood pressure and a trend to decrease heart rate, that makes this agent a promising therapy for the acute heart failure patients with low output stage.”