ALLSCHWIL, SWITZERLAND – 08 May 2014 – Actelion Ltd (SIX: ATLN) announced
that the Independent Data Monitoring Committee (DMC) has informed the company of its
unanimous recommendation to continue the pivotal Phase III study, GRIPHON. In addition
the DMC had no recommendations for any modification in study design or procedures.
The placebo-controlled, randomized GRIPHON study is designed to evaluate the efficacy
and safety of selexipag in 1.150 patients with pulmonary arterial hypertension (PAH) in an
event-driven morbidity/mortality study.
Selexipag is an orally available selective IP receptor agonist that – in a Phase II study –
showed a significant reduction in pulmonary vascular resistance (PVR). Pulmonary arterial
hypertension (PAH) is a syndrome characterized by a progressive increase in pulmonary
vascular resistance.
As described in the study protocol, the GRIPHON DMC was scheduled to perform an
interim analysis at around two thirds of the overall foreseen morbidity/mortality events were observed, in addition to the evaluation of patient safety in the study. The goal of the interim analysis was to assess whether study continuation was warranted based on the primary objective of demonstrating morbidity/mortality benefits.
With the interim analysis now successfully concluded and the DMC recommending study
continuation as planned, final study results of this event-driven study are now expected by
mid-2014.