The 24-week randomized placebo-controlled, double-blind, multi-center Impres trial involving 202 patients is intended to evaluate the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of patients with PAH.
In the study, the drug demonstrated improvement in the six-minute walk distance (6MWD) test in patients with elevated pulmonary vascular resistance (PVR) despite treatment with two or more specific PAH vasodilator therapies.
It is also found that QTI571 produced significant improvements in pulmonary arterial pressure, cardiac output and pulmonary vascular resistance, compared to placebo.
QTI571 is currently not approved to treat PAH and is planned to be submitted for regulatory approval later this year for the treatment of this disease.
Novartis Development in the Pharmaceuticals Division global head Trevor Mundel said if approved, QTI571 can provide a further treatment option for patients where current therapies are not providing sufficient benefit in the treatment of this life-threatening disease.