Santhera Will Present Phase III Data On Idebenone for DMD at the Annual Meeting of the American Academy Of Neurology

Santhera Pharmaceuticals‘ Principal Investigator Gunnar M. Buyse will be presenting Phase III data on Idebenone (Raxone^®/Catena^®) for the treatment of Duchenne Muscular Dystrophy (DMD) at the Annual Meeting of the American Academy of Neurology (AAN).

Buyse’s oral presentation entitled, “Idebenone Reduces Loss of Respiratory Function in Duchenne Muscular Dystrophy-Outcome of a Phase III Double Blind, Randomized, Placebo controlled Trial (DELOS)” will be held on Friday, April 24 between 12 and 1:30 pm during the Clinical Trials Plenary Session. This session was organized by the AAN to include crucial clinical topics identified by the neurology community to affect patient care; the DELOS outcome was considered by the Science Committee as a critical advancement in the area of neuroscience.

“Progressive lung disease and irreversible loss of lung function are a main cause of morbidity and early mortality in DMD. The statistically significant and clinically relevant outcomes of primary and secondary endpoints of this Phase III trial coherently demonstrate the therapeutic potential of idebenone in reducing the loss of respiratory function,” said Buyse in a press release.

Thomas Meier, Santhera’s CEO commented: “I am excited that Professor Buyse was invited by the organizers of this year’s AAN conference to present the outcome of this first successful phase III trial in DMD as a prominent lecture to a general audience of neurologists. This is as much a tribute to the positive outcome of the trial as it is tribute to the scientists and patients and families conducting it.”

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DELOS was a double-blind, randomized, placebo-controlled, Phase III trial that treated 64 patients (American and European) suffering with DMD are that are not receiving concomitant corticosteroids. Patients were between 10 and 18 years old and received for 52 weeks Raxone/Catena tablets (900 mg/day) or matching placebo. (Read more)

Raxone/Catena (idebenone) is a synthetic short-chain benzoquinone that is able to stimulate electron transport in mitochondria and to supplement cellular energy levels.

Santhera Pharmaceuticals is a Swiss based pharmaceutical firm currently developing and commercializing innovative products to address treatment of neuromuscular and orphan mitochondrial diseases. The hope is that the data presented during Dr. Buyse’s anticipated presentation will spur continued development of Idebenone as a viable treatment for DMD.