Actelion provides update on Phase III GRIPHON study with selexipag in pulmonary arterial hypertension - Study continues

Actelion Pharmaceuticals Ltd / Actelion provides update on Phase III GRIPHON study with selexipag in pulmonary arterial hypertension - Study continues . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement.

ALLSCHWIL, SWITZERLAND - 08 May 2013 - Actelion Ltd (SIX: ATLN) announced today 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.

 

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Notes to Editor:

ABOUT GRIPHON

GRIPHON, (Prostacyclin (PGI2) Receptor agonist in pulmonary arterial hypertension) is a multicenter, double-blind, placebo-controlled trial evaluating the long-term efficacy and safety of oral selexipag in patients with pulmonary arterial hypertension.

GRIPHON is close to full enrollment with 1'143 patients randomized, of the targeted 1'150, and represents the largest randomized, controlled study in PAH patients. This pivotal study is designed to demonstrate a reduction in risk of morbidity/mortality events of selexipag treatment compared to placebo and evaluate the safety of the selexipag in PAH patients. Results are expected to be available mid-2014.