Selexipag for Raynaud’s Phenomenon Tested in Clinical Trial

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by Maureen Newman |

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Raynaud's PhenomenonSelexipag (ACT-293987), under development by Actelion, may be able to help individuals affected by “Raynaud’s Phenomenon Secondary to Systemic Sclerosis” in an international phase 2 clinical trial that is currently recruiting participants. The trial, initiated in October 2014, is slated to end in April 2015 with results compiled by May. Results will illustrate the effects of selexipag on the frequency of Raynaud attacks in patients affected with the condition secondary to scleroderma.

A predicted 70 Raynaud’s phenomenon patients will be treated for 56 +/- 7 days throughout the course of the study. Participants will be segmented into Two cohorts — the first will be treated with 200 micrograms of selexipag in an oral tablet twice daily, and the second will be treated similarly with a placebo.

At baseline, patients must have recurrent multiple weekly Raynaud’s phenomenon attacks as a result of their clinically defined scleroderma. None may take prostacyclin or prostacyclin analogs, as these would confound the results of the study.

The primary outcome measure is frequency of Raynaud’s phenomenon attacks, and patients will self-report attacks using a daily electronic diary. Additionally, adverse events and quality of life will be evaluated until the end of treatment. Quality of life will be determined through the scleroderma Health Assessment Questionnaire (sHAQ).

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Originally discovered by Nippon Shinyaku, a research and development company in Japan, selexipag selectively targets prostacyclin receptors on vascular smooth muscle cells. By binding to the prostacyclin receptor, selexipag induces a vasodilation response in blood vessels. It is suggested this response enables blood flow to areas that feel cold to individuals with Raynaud’s phenomenon, as the main contributor to a feeling of coldness in this condition is vasoconstriction and limited blood flow.

Actelion submitted a new drug application for Selexipeg to the United States’ FDA and Europe’s EMA to treat patients with pulmonary arterial hypertension. Submission was contingent on a phase 3 clinical trial called Prostacyclin (PGI2) Receptor Agonist In Pulmonary Arterial Hypertension (GRIPHON), which demonstrated long-term efficacy and safety of orally administered selexipag in doses of 200 to 1,600 micrograms twice daily.

If selexipag proves to be safe and effective in reducing Raynaud’s attacks in patients with scleroderma, Actelion may continue to develop the drug and submit an approval application. Similarly pursued treatments include alprostadil, under investigation by NexMed (USA), a topically applied treatment for Raynaud’s phenomenon.