Catena success in Phase III trial for Duchenne Muscular Dystrophy - Santhera

The Phase III, double-blind, placebo-controlled DELOS study randomized 65 Duchenne Muscular Dystrophy patients who were 10-18 years of age and who were not using concomitant corticosteroids. The study met the primary endpoint, the difference between Catena/Raxone and placebo in the change from baseline to week 52 in Peak Expiratory Flow (p=0.04). Peak Expiratory Flow is a measure of respiratory muscle strength, the decline of which is a major contributing factor to morbidity and mortality in DMD. Catena/Raxone (900 mg/day) was safe and well tolerated with adverse event rates comparable to placebo. Other endpoint analyses are ongoing and results of these will be disclosed shortly.