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Home Industry News Actelion launches ‘largest ever’ PAH study

Actelion launches ‘largest ever’ PAH study

28th December 2007

Actelion has announced the launch of the largest ever study demonstrating the morbidity and mortality benefits of its endothelin receptor agonist in patients with pulmonary arterial hypertension (PAH).

The phase III study, entitled Seraphin, will examine the safety and efficacy of Actelion-1 in delaying disease progression and mortality in PAH patients.

Seraphin will see over 500 patients enrol from at least 180 centres where patients will receive two different doses of Actelion-1 (3mg or 10mg once-daily) or a placebo.

The study will evaluate the efficacy of Actelion-1 by using the clinical endpoint of morbidity and all-cause mortality in patients with symptomatic PAH.

Dr Gerald Simonneau, advisor to the Seraphin steering committee, stated that Actelion had “raised the bar again” in initiating the trial and investigating morbidity-mortality from the beginning in order to demonstrate the potential of Actelion-1.

Actelion’s chief executive officer Jean-Paul Clozel also commented: “With Actelion-1, we are renewing our commitment to the PAH community and our dedication to true innovation with the potential to once more transform medicine.”

Also this month, Actelion launched its phase III programme Restora to investigate its orexin receptor antagonist almorexant.

The programme is intended to confirm the efficacy and safety of the drug in patients suffering from primary insomnia.

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