Phase IIa study of RNS60 initiated for multiple sclerosis


Revalesio announced on 11 November a new collaboration with neurologist Roland Martin, head of Neuroimmunology and MS Research at the Department of Neurology, University Hospital Zurich, Switzerland. Martin is to conduct a phase IIa clinical trial of RNS60 in patients with relapsing-remitting multiple sclerosis (RRMS).

The study is expected to compare measurements of disease activity and progression in patients with RRMS during six-months treatment with RNS60. The open-label study will enrol 15 patients and evaluate the use of RNS60 by intravenous administration compared to patient’s pre-treatment disease activity.

The main outcome of the study will be the reduction of inflammatory activity in the brain as measured by Gd contrast-enhacing MRI lesions. Additional measures include progression of disability and biomarkers for RNS60 and general inflammation. The study will be conducted at the University Hospital Zurich in Switzerland and at Innsbruck Medical University in Innsbruck, Austria.

“Our multiple sclerosis development work with RNS60 has been an extraordinary process of discovery and pioneering research,” says Richard Watson, Revalesio’s chief science officer. “We have published much of our data regarding RNS60’s mechanisms in the pre-clinical models and are pleased to have Martin as a collaborator and to see RNS60 advance into the clinic for multiple sclerosis. We are hopeful this study will provide an efficacy signal that demonstrates RNS60’s therapeutic potential and informs future clinical research.”

According to a press release, RNS60 has been tested in numerous pre-clinical models of multiple sclerois and has shown the ability to halt disease progression by limiting glial infiltration (inflammation in the brain), protecting myelin and enriching the regulatory T-cell (TREG) populations in animals treated with RNS60. Data from these pre-clinical models us published in PLOS ONE.