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Info on Clinical Trial
Clinical research activities
In order to evaluate the validity of the mitochondrial targeted approach for the treatment of neurodegenerative diseases, MitoTarget’s partners will perform, alongside the basic research section of the project, a clinical trial which will aim at demonstrating the safety and efficacy of Trophos’ compound TRO19622 (olesoxime) in the treatment of Amyotrophic Lateral Sclerosis (ALS).
ALS is a is a devastating illness that is fatal within five years of diagnosis in 80 percent of cases and which is estimated to affect over 100,000 people worldwide. There is no cure for ALS, the only drug approved for the disease being riluzole (Sanofi-Aventis), which has been demonstrated to give a significant yet modest 2-3 month survival benefit to ALS patients.
TRO19622 is the lead compound of the Trophos' proprietary cholesterol-oxime compound family of mitochondrial pore modulators. Preclinical studies have demonstrated that the compound promotes the function and survival of neurons and other cell types under disease-relevant stress conditions through interactions with the mitochondrial permeability transition pore (mPTP) and TRO19622 has been shown to be active in the SOD1 model of ALS (Bordet et al., JPET 322:709-720, 2007).
TRO19622 has successfully completed phase I studies in healthy volunteers and phase Ib studies in ALS patients. These clinical trials demonstrated that the product is well-tolerated and has an excellent safety profile. They also showed that once-a-day oral dosing achieves the predicted exposure level required for efficacy, based on preclinical models. Drug interaction studies with riluzole showed no interaction of TRO19622 on riluzole pharmacokinetics.
- More Info on the MitoTarget Clinical Trial for Physicians
- Informations sur l’essai Clinique Mitotarget pour les Medecins
- Informationen Über die Klinische Prüfung Mitotarget für Ärzte
- Información Sobre el Ensayo Clínico Mitotarget para Médicos
- Informatie Over het Mitotarget Klinische Onderzoek Voor Artsen
