GENEVA--(BUSINESS WIRE)--Regulatory News:

GeNeuro (Paris:GNRO) (Euronext Paris: CH0308403085 - GNRO), announced today a collaboration for a new clinical trial of temelimab in multiple sclerosis (MS) with clinical researchers of Karolinska Institutet and the Academic Specialist Center (ASC), Stockholm, Sweden. This single-center study will be led by Dr. Fredrik Piehl, Professor of Neurology at the Department of Clinical Neurosciences of the Karolinska Institutet, and head of research at the MS clinic at ASC.

The trial will be conducted at Center for Neurology of ASC, the largest MS center in Sweden with approximately 2,400 patients. The one-year trial will enroll patients whose disability progresses without relapses, and will document the safety and tolerability of temelimab following higher doses, as well as efficacy based on the latest biomarkers associated with disease progression. The study aims to start enrolling patients in Q1 2020.

It is evident that currently available disease modulatory therapies for MS exert very limited effects on the progressive aspect of MS and that this phase starts early in the disease course. A role of pHERV-W Env in progressive disease worsening is supported by accumulating preclinical and clinical evidence. We are excited to explore the therapeutic potential of temelimab in patients progressing without relapses. This constitutes a key unmet medical need in MS and will allow us to push the boundaries of current therapeutic possibilities, said Prof. Fredrik Piehl, Principal Investigator of the study.

Temelimab is a monoclonal antibody designed to neutralize a pathogenic envelope protein, pHERV-W Env, which has been shown to activate microglia in the brain resulting in an aggressive phenotype attacking myelin1, and to impair the remyelination capacity of the brain through the inhibition of oligodendrocyte precursor cell differentiation2. This collaboration follows the data from GeNeuros ANGEL-MS clinical trial results, presented at ECTRIMS, which demonstrated positive results at two years on key markers associated with disease progression.

Long-term data have confirmed the neuroprotective effect of temelimab in MS and demonstrated its potential to make significant improvements in the lives of patients. We are very proud to be working with Prof. Piehl, who is recognized for his leading research at the Karolinska Institutet and the ASC, to further advance the development of temelimab as a potential treatment against disability progression in MS, said Jess Martin-Garcia, CEO of GeNeuro.

About GeNeuro

GeNeuros mission is to develop safe and effective treatments against neurological disorders and autoimmune diseases, such as multiple sclerosis, by neutralizing causal factors encoded by HERVs, which represent 8% of human DNA. GeNeuro is based in Geneva, Switzerland and has R&D facilities in Lyon, France. It has 24 employees and rights to 17 patent families protecting its technology.

For more information, visit: https://www.geneuro.com

About the Academic Specialist Center

The Academic Specialist Centre is a collaboration between Stockholm Health Care Services and Karolinska Institutet, providing a novel concept for research and intensive outpatient care. It is a part of the Swedish investment in future healthcare aimed at forging stronger links between research and development, education and healthcare.

The ASC provides specialist care to patients with diabetes, MS, Parkinsons and rheumatological disorders, and conducts cutting-edge clinical trials in these indications.

For more information, visit https://ki.se/en/collaboration/collaboration-with-the-health-services

Disclaimer

This press release contains certain forward - looking statements and estimates concerning GeNeuros financial condition, operating results, strategy, projects and future performance and the markets in which it operates. Such forward-looking statements and estimates may be identified by words, such as anticipate, believe, can, could, estimate, expect, intend, is designed to, may, might, plan, potential, predict, objective, should, or the negative of these and similar expressions. They incorporate all topics that are not historical facts. Forward looking statements, forecasts and estimates are based on managements current assumptions and assessment of risks, uncertainties and other factors, known and unknown, which were deemed to be reasonable at the time they were made but which may turn out to be incorrect. Events and outcomes are difficult to predict and depend on factors beyond the companys control. Consequently, the actual results, financial condition, performances and/or achievements of GeNeuro or of the industry may turn out to differ materially from the future results, performances or achievements expressed or implied by these statements, forecasts and estimates. Owing to these uncertainties, no representation is made as to the correctness or fairness of these forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates speak only as of the date on which they are made, and GeNeuro undertakes no obligation to update or revise any of them, whether as a result of new information, future events or otherwise, except as required by law.

1 Kremer et al., PNAS July 20192 Kremer et al., Annals of Neurology, June 2013; Gttle et al, Glia, August 2018

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GeNeuro and the Karolinska Institutet/Academic Specialist Center of Stockholm Agree to Launch a New Clinical Study of Temelimab in Multiple Sclerosis...