Bayer HealthCare announces phase IIIb trial of riociguat

Bayer HealthCare has announced it has enrolled the first patient in its multi-national phase IIIb trial, riociguat clinical effects studied in patients with insufficient treatment responses to PDE-5 inhibitors (RESPITE).

The study has been designed to assess the clinical efficacy of the drug for use in patients diagnosed with pulmonary arterial hypertension (PAH), either as a standalone treatment or in combination with an endothelin receptor antagonist (ERA).

Dr Joerg Moeller, Bayer's head of global development and executive committee member, said: "A large proportion of PAH patients treated with PDE-5 inhibitors does not reach or maintain specific treatment goals."

In its PATENT-1 phase III clinical trial, riociguat was shown to have a robust efficacy when across multiple clinically relevant endpoints when delivered orally, either as a monotherapy or when delivered alongside ERA or prostacyclin analogue. 

Riociguat has been approved under the name Adempas in the US for use with PAH and chronic thromboembolic hypertension and has been recommended for European approval by the European Committee for Medicinal Products for Human Use.