Actelion has suffered a pipeline setback with the failure of its asthma and seasonal allergic rhinitis drug setipiprant in a mid-stage and a late-stage trial.
The Swiss biotech says that it will "re-direct its development efforts in the anti-inflammatory area", following two recently-concluded studies with setipiprant, the first orally-active CRTH2 antagonist. The results in asthma (Phase IIb) and SAR (Phase III) did not confirm efficacy findings made in earlier studies, so "clinical development with this well-tolerated agent in these indications is being discontinued".
Actelion said that it is now focusing on "a potent follow-up CRTH2 antagonist currently in Phase I" and further developing the understanding of the CRTH2 mechanism "as a potential anti-inflammatory mode of action in allergic indications".
Actelion's shares were not particularly hurt by the news as observers are more focused on a Phase III trial of macitentan, a potential successor to its pulmonary arterial hypertension blockbuster Tracleer (bosentan). Top-line results are due in the second quarter.
Zavesca approved for NP-C disease in Japan
Meantime, the Allschwil-based company announced that regulators in Japan have given the green light to its Gaucher disease drug Zavesca (miglustat) as a treatment for an even rarer condition.
Japan's Ministry of Health, Labour and Welfare has granted approval for miglustat for the treatment of Niemann-Pick type C disease, a rare, neurodegenerative genetic disorder. The thumbs-up was based on the data generated for the first approval of miglustat in this indication in the European Union, as well as data specifically generated for the submission to the Japanese Health Authorities.
The drug will be marketed as Brazaves.