Santhera's Raxone/Catena Phase III trial gives positive results in Duchenne muscular dystrophy

Swiss pharma company Santhera (SIX: SANN) has announced positive Phase III results for its Raxone/Catena (idebenone) in Duchenne muscular dystrophy (DMD).

The results of the DELOS trial showed that Raxone/Catena significantly reduced the annual decline in peak expiratory flow by 66% compared to patients given placebo. Other respiratory function endpoints such as forced vital capacity and forced expiratory volume corroborated these results and showed a consistent pattern.

Gunnar Buyse, principal investigator in the DELOS trial and lead study author, said: "Publication of the DELOS trial outcome in The Lancet, one of the most prestigious medical journals worldwide, is an extraordinary tribute to this first ever successful Phase III trial in DMD. It's also a tribute to the hard work of so many scientists, patients and families involved in the 10 years of innovative research in which we have brought idebenone from the lab bench to the patient. Statistically significant and clinically relevant outcomes of primary and secondary endpoints coherently demonstrated that Raxone/Catena reduced the loss of respiratory function and that it was safe and well tolerated. I am very enthusiastic about the positive data from the trial which demonstrate that this drug represents a suitable treatment option to ameliorate a life-threatening complication of the disease."