GeNeuro Completes Patient Recruitment in Temelimab Phase 2 Multiple Sclerosis Trial at the Karolinska Institutet’s Academic Specialist Center (ASC)
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- Enrolment completed for the 48 week ProTEct-MS Phase 2 study
- Phase 2 top-line results on tack to be reported in Q1 2022, as previously announced
GENEVA--(BUSINESS WIRE)-- Regulatory News:
GeNeuro (Euronext Paris: CH0308403085 - GNRO), a biopharmaceutical company focused on stopping causal factors driving the progression of neurodegenerative and autoimmune diseases, such as multiple sclerosis (MS), today announced the completed patient recruitment in its Phase 2 trial of temelimab in MS patients, conducted at the Karolinska Institutet’s Academic Specialist Center (ASC), in Stockholm (Sweden). Temelimab is a monoclonal antibody designed to neutralize a pathogenic retroviral envelope protein, pHERV-W Env.
The study, called ProTEct-MS, has enrolled a very homogenous cohort of 42 patients being treated with temelimab (18, 36 and 54mg/kg) vs. placebo and evaluated for 48 weeks. The patients included in the study had confirmed disability progression without relapses, following previous treatment with the anti-CD20 drug rituximab, a highly potent and efficacious drug against acute disease activity (relapses and brain lesion formation). The double-blind placebo-controlled study has been designed to assess safety, tolerability and efficacy measures based on the latest biomarkers associated with disease progression.
“Modern MS therapies strongly suppress relapse activity, but have little effect on the long-term course of disability. ProTEct-MS pursues a novel therapeutic concept where an anti-neurodegenerative compound, temelimab, is administered to patients already on a high-efficacy anti-inflammatory therapy. Temelimab has already been shown to have a neuroprotective effect in MS and it has the potential to address the key unmet medical need of disability progression, so we look forward to the results of this important study in Q1 2022,” said Prof. David Leppert, Chief Medical Officer of GeNeuro. “We are very grateful to the patients who have agreed to participate in this important study and we also thank the team at Karolinska Institutet’s Stockholm Academic Specialist Center for their great efforts that have allowed to dramatically cut the delay due to the COVID-19 pandemic from the initial 3 month estimate down to 6 weeks.”
GeNeuro’s temelimab Phase 2 trial in MS patients at the Karolinska Institutet’s Academic Specialist Center followed the successful results achieved in its 96-week extension Phase 2b clinical trial, ANGEL-MS, which confirmed the neuroprotective effect of temelimab in MS and demonstrated its potential to suppress the progression of the disease.
“MS disease progression continues to be a major unmet need and we are eager 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. “The patient response to the study as well as their dedication to participation in the complex COVID-19 context has been very encouraging.”
GeNeuro‘s mission is to develop safe and effective treatments against neurological disorders and autoimmune diseases, such as multiple sclerosis, by neutralizing causal factors encoded by human endogenous retroviruses (HERVs), which represent 8% of human DNA.
GeNeuro is based in Geneva, Switzerland and has R&D facilities in Lyon, France. It has rights to 17 patent families protecting its technology.
For more information, visit: www.geneuro.com
This press release contains certain forward - looking statements and estimates concerning GeNeuro’s 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 management’s 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 company’s 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.
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