Spyryx's SPX-101 improves lung function in Phase II CF trial

Spyryx Biosciences Inc. (Durham, N.C.) said high-dose SPX-101 given via a portable nebulizer led to a placebo-adjusted increase in percent predicted forced expiratory volume in 1 second (ppFEV1) from baseline to day 28 of 5.2% (p=0.054) in the first cohort of the Phase II HOPE-1 trial to treat cystic fibrosis independent of CF transmembrane conductance regulator (CFTR) mutation type. Data were presented at the European Cystic Fibrosis Society meeting in Belgrade on June 8.

The double-blind, international trial is slated to enroll about 90 patients to receive placebo or twice-daily 60 or 120 mg SPX-101 inhalation solution for 28 days. The first cohort comprised 46 patients with a baseline ppFEV1 of 40-80%. In a subgroup of 20 patients in the first cohort with a baseline ppFEV1 of >55%, high-dose SPX-101 led to a placebo-adjusted increase in ppFEV1 from baseline to day 28 of 8.3% (p=0.048)...