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Celtaxsys To Hash Out Phase III Cystic Fibrosis Endpoints With US FDA

 
• By Emily Hayes

Private start-up's acebilustat failed to improve lung function in Phase II, but the anti-inflammatory showed large numerical reductions in pulmonary exacerbations, which can be fatal.

Kid with cystic fibrosis lying in a hospital bed with oxygen mask and plush toy

Atlanta-based, private start-up Celtaxsys Inc. is gearing up to talk to the US FDA about using pulmonary exacerbations as the Phase III primary endpoint for its cystic fibrosis therapy acebilustat, after the anti-inflammatory drug failed to significantly improve the forced expiratory volume in one second (FEV1) measure in the Phase II EMPIRE-CF study.

Celtaxsys reported Aug. 2 that acebilustat improved FEV1 only numerically by 1% in the EMPIRE-CF Phase II study of 200...

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