Actelion has kicked off Phase III development of its once-daily multiple sclerosis pill ponesimod, with patient enrolment in the OPTIMUM trial expected imminently.
The study is expected to enrol around 1,100 subjects, and aims to determine whether ponesimod, a selective S1P1 receptor modulator, is more effective at reducing relapses than Sanofi’s Aubagio (teriflunomide).
"Ponesimod brings a number of unique properties, which include selectivity for the S1P1 receptor, rapid onset of action, a clear dose-response, and rapid reversibility upon discontinuation, an important option for physicians in case restoration of the immune system is required,” said Guy Braunstein, Head of Global Clinical Development at the Swiss biotech.
“We are convinced that - following regulatory approval - all these features and the data collected can make ponesimod an important oral therapeutic option,” he noted.
Actelion said it will also initiate a Phase II study with ponesimod in patients suffering from chronic graft versus host disease, while a second selective S1P1 receptor modulator will be pushed into Phase II clinical development in patients with systemic lupus erythematosus.
The firm’s progress in the immunology field will undoubtedly please investors, many of which have long voiced concerns over its reliance on the pulmonary arterial hypertension blockbuster Tracleer (bosentan).