Actelion’s Selexipag Study: A New Hope for Pediatric PAH

Actelion ((ALIOF)) announced an update on their ongoing clinical study.

Actelion is conducting a Phase 2 clinical study titled ‘A Prospective, Multicenter, Open Label, Single Arm, Phase 2 Study to Investigate the Safety, Tolerability and Pharmacokinetics of Selexipag in Children With Pulmonary Arterial Hypertension.’ The study aims to confirm the appropriate starting doses of Selexipag for children with Pulmonary Arterial Hypertension (PAH) by comparing pharmacokinetic data with adult doses. This research is significant as it seeks to ensure safe and effective treatment for young PAH patients.

The intervention being tested is Selexipag (Uptravi), a drug administered orally in film-coated tablets. It is designed to manage PAH by improving blood flow in the lungs and reducing the workload on the heart.

The study follows an interventional design with a single-group model and no masking, focusing primarily on treatment. Participants are allocated to receive Selexipag, which is up-titrated to their maximum tolerated dose over 12 weeks, followed by a maintenance period.

The study began on July 23, 2018, with primary results submitted in March 2023. The estimated study completion date is August 14, 2025. These timelines are crucial for tracking progress and assessing the study’s impact on treatment protocols.

This update could positively influence Actelion’s stock performance and investor sentiment, given the potential for Selexipag to address a critical need in pediatric PAH treatment. Competitors in the PAH treatment space may also be impacted as the study progresses.

The study is ongoing, with further details available on the ClinicalTrials portal.