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Santhera Enters Agreement with Columbia University to Investigate Additional Potential of Catena in MELAS

29 Jun 2009 - Santhera Pharmaceuticals announced a collaboration with Columbia University in New York to investigate Catenaź in a Phase II study as treatment of MELAS (Mitochondrial Encephalopathy, Lactic Acidosis, and Stroke-like episodes). The MELAS syndrome is a rare but devastating multisystem disorder that affects the brain, nervous system, muscles and cognitive abilities. Currently, there are no approved therapies available or in development to help people with MELAS. The announcement follows shortly after a similar collaboration between Santhera and the US National Institutes of Health to investigate Catenaź in Primary Progressive Multiple Sclerosis.
 
The MELTIMI (MELAS Trial of Idebenone using MRS) trial is a Phase II double-blind, placebo-controlled study investigating the safety and efficacy of two doses of Catenaź (INN: idebenone) versus placebo. The primary endpoint of the proof-of-concept study is the change in cerebral lactate concentration from baseline to week four as assessed by Magnetic Resonance Spectroscopy (MRS). The MELTIMI study will also investigate additional endpoints such as venous lactate levels, fatigue and quality of life. The lactate level is considered a viable biomarker associated with the neurological impairment in MELAS. Overall, the MELTIMI study will enroll 21 patients aged between 8 and 65 years.
 
The MELTIMI study is being performed at Columbia University. Under the agreement, the Neurological Institute of Columbia University is conducting the clinical trial while Santhera is supplying the study medication and contributes data management and other support. The Company has exclusive rights to the data for regulatory purposes.