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Edison Pharmaceuticals Announces Phase 2 Positive Clinical Results for EPI-743 in Rett Syndrome
Date:9/2/2014

in the EPI-743 treatment arm.

In this study, EPI-743 was well-tolerated with no drug-related serious adverse events or dose-limiting toxicities reported.

The rationale for the trial was to determine if EPI-743 could address putative mitochondrial/oxidative stress components of Rett syndrome.

"Given the established role of oxidative stress in the pathology of Rett syndrome, we were interested in exploring whether a mitochondrial-targeted therapeutic would result in treatment benefit," said Joussef Hayek, MD, Professor of Child Neuropsychiatry and Principal Investigator of the study. "This study represents an important step in building a bridge between understanding the underlying pathology of Rett syndrome and discovering new treatments."

"With the encouraging results on such an objective and meaningful endpoint, we plan to engage with health authorities, patient foundations, and the clinical/research community in the next several months to define the next steps that may ultimately lead to new options for children with Rett syndrome and other mitochondrial diseases," said Matthew Klein, MD MS FACS, Chief Medical Officer at Edison Pharmaceuticals, Inc.

Rett Syndrome
Rett syndrome is a severe rare neurodevelopmental disorder affecting females almost exclusively. The disease results in slowing of brain growth, seizures, loss of motor function, loss of speech, and impaired respiratory function, as well as a characteristic hand stereotypy with progressive loss of purposeful hand function. Children with Rett syndrome also demonstrate autistic-like features, including diminished eye contact; for this reason Rett syndrome has been considered an autism spectrum disorder. Recent studies have demonstrated that Rett syndrome is characterized by high levels of systemic oxidative stress as well as alterations in mitochondrial morphology. Plasma levels of oxidative stress biomarkers have bee
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SOURCE Edison Pharmaceuticals, Inc.
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