Positive Ph III results with Santhera’s Catena/Raxone in Duchenne muscular dystrophy

Swiss drugmaker Santhera Pharmaceuticals (SIX: SANN) has released positive Phase III, double-blind, placebo-controlled DELOS study randomized 65 Duchenne muscular dystrophy (DMD) 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 (idebenone) 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 (900mg/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.

"We are thrilled by these results which are consistent with the findings of our Phase II DELPHI and DELPHI Extension studies," commented Thomas Meier, chief executive of Santhera.

Will start discussion on regulatory pathway