Trophos SA, a clinical stage pharma company developing innovative therapeutics from discovery to clinical validation for indications with under-served needs in neurology and cardiology, announced the award of a Euro 1 million grant to support the Translate-MS-Repair project.
The French 'Agence Nationale de la Recherche' (ANR) awarded the second successive grant to Trophos to target multiple sclerosis with olesoxime. The funding will be provided under the Recherches Partenariales et Innovation Biomedicale 2012 programme.
Translate-MS-Repair will be a 24-month project and will include a phase Ib/IIa clinical study of olesoxime, Trophos' lead compound, to target neurodegeneration that underlies long term progressive disability in multiple sclerosis.
The project will be operated by a consortium spearheaded by Trophos including leading experts in Marseille (AP-HM/CNRS and CEMEREM-CRMBM), Rennes (CHU de Rennes and INRIA VISAGES) and Reims (CHU de Reims).
The clinical trial, which will be performed in 3 centres in France, will be led by Dr. Jean Pelletier AP-HM/CNRS-CEMEREM. The clinical trial is designed to demonstrate the compatibility of olesoxime as a co-medication with existing treatments, the most frequent being beta interferon. The study will also assess the feasibility of non-conventional magnetic resonance imaging procedures in a multicentre trial. The clinical trial is designed to result in future large-scale clinical trials to assess efficacy of olesoxime to prevent progressive disability in MS patients.
"MS is the first cause of non-traumatic disability in young adults. While there are a number of effective treatments to control the relapsing inflammatory episodes, they have little effect on progressive disability in MS patients," said Rebecca Pruss, CSO, Trophos. "MS is a chronic inflammatory disease leading to demyelination and axonal degeneration in the central nervous system. However, it is now also recognized that MS is a neuro-degenerative disease as well. There is a real unmet need for agents to promote neuroprotection and myelin repair for MS."
"The second grant from the ANR to Trophos for our MS programme is a recognition of the quality of Trophos' ongoing activity in neurodegenerative diseases within the Trophos pipeline," said Christine Placet, CEO, Trophos. "The ongoing success of olesoxime and the Trophos pipeline fits perfectly with Trophos strategy value creation."
Translate-MS-Repair is a sequel to the successful ANR funded MS-Repair project lead by Trophos and performed in collaboration with Aix-Marseille University and CNRS partners, IBDML (UMR 6216) and CRMBM (UMR 6612). MS-Repair (ANR-08-BIOT-016-01) explored from 2008 to 2011 the activity of the molecule olesoxime in various in vitro and in vivo models of MS. This project showed that the molecule is not only neuroprotective, but it has the ability to promote the maturation of oligodendrocyte progenitor cells (OPCs) into myelinating oligodendrocytes (details in Magalon et al, Ann Neurol. 2012 Feb;71(2):213-26).
Translate-MS-Repair is a consortium spearheaded by Trophos with 3 clinical centers (Assistance Publique Hôpitaux de Marseille, Centre Hospitalier Universitaire de Rennes, Centre Hospitalier Universitaire de Riems) and two MRI specialist labs (Centre National de la Recherche Scientifique CEMEREM and INRIA VISAGES). The consortium members have been specifically selected to complete this study. The Phase 1b/2a study will be a randomized, placebo-controlled, double blind study to evaluate the effect of olesoxime in 30 relapsing remitting MS patients stably treated with beta interferon 1a. A range of conventional and non-conventional MRI procedures will be performed at enrollment and after 6 months of treatment. The primary outcome will be the change in relapse rate to assure that olesoxime treatment is compatible with interferon. The study will also assess the feasibility of performing non-conventional MRI including 23Na-MRI, diffusion tensor imaging, magnetic transfer resonance and magnetic resonance spectroscopy in a multicenter trial.