Actelion's PGI2 receptor agonist demonstrates efficacy in pulmonary arterial hypertension patients
Morbidity-Mortality Phase III study to be initiated before year-end
Actelion Ltd announced that positive data have been obtained in a Phase IIa study with its first-in-class orally active non-prostanoid PGI2 receptor agonist in pulmonary arterial hypertension (PAH) patients.
In the 43 patient placebo-controlled double-blind study to assess efficacy, safety and tolerability the primary endpoint of change from baseline in pulmonary vascular resistance (PVR) was met with high statistical significance (P<0.01). The compound was well tolerated in the study.
The positive study results support advancing this first orally active non-prostanoid PGI2 receptor agonist into Phase III. This approach was previously discussed and agreed with the FDA while the study was ongoing. Actelion will now rapidly approach the FDA to finalize the design for a Phase III program with a morbidity/mortality endpoint. Consequently, Actelion expects to initiate this program before year-end.
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