IDSMB backs continuation of Santhera's Ph III Catena trial in DMD, but now needs partner

Swiss drugmaker Santhera Pharmaceuticals (SIX: SANN) says that the Phase III DELOS study of orally administered Catena (idebenone) in patients with Duchenne muscular dystrophy (DMD) successfully passed a planned futility and safety analysis. The independent Data Safety Monitoring Board (DSMB) says that the study has a reasonable chance of achieving its primary endpoint for improving or delaying the loss of respiratory function in Duchenne patients not using corticosteroids and, since no safety issues were detected, recommended that the study should continue as planned.

"I am very enthusiastic about this news, which is important for the DMD community as it indicates that Catena eventually may evolve into a real treatment for all patients with this devastating disease. Importantly it suggests that the DELOS data are consistent with the outcome of the Phase II DELPHI study, which showed that treatment with Catena resulted in a significant increase in peak expiratory flow and may improve early signs of respiratory weakness and dysfunction," commented Gunnar Buyse, Professor of Child Neurology at the University Hospitals Leuven (Belgium) and Principal Investigator for the DELOS study. "Some promising therapies for DMD have failed to demonstrate clinical benefit in late-stage development, so it is encouraging to see that we now may be on track to clear this hurdle for this patient group," he added.

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