GENEVA--(BUSINESS WIRE)--Regulatory News:
GeNeuro (Paris:GNRO) (Euronext Paris: CH0308403085 - GNRO), a biopharmaceutical company focused on stopping causal factors driving the progression of neurodegenerative and autoimmune diseases, such as multiple sclerosis, today announced that the top-line results of the ProTEct-MS study confirm the excellent safety profile and tolerability of higher doses of temelimab, up to 54mg/kg, used in combination with rituximab, a high-efficacy anti-CD20 drug, thus meeting the primary endpoint of the ProTEct-MS study.
This study, performed at the Karolinska Institutet’s Academic Specialist Center in Stockholm under the leadership of Prof. Fredrik Piehl, enrolled 41 Multiple Sclerosis (MS) patients treated with rituximab and in whom disability was worsening in the absence of relapses. The primary outcome of the study was a safety evaluation. The drug was well tolerated with no treatment related discontinuations, no serious or severe treatment emergent adverse events, and no differences in overall clinical or laboratory safety findings.
Efficacy data (secondary & exploratory measures) demonstrated that temelimab, which had been used as a monotherapy in previous trials, showed beneficial trends on key parameters of neurodegeneration measured by MRI. These benefits were seen in a patient population that was already treated for at least one year with rituximab, a highly effective anti-neuroinflammatory medication.
“The fact that we here prove the feasibility and potential added benefit of combining two therapies with different modes of action, is very encouraging,” said Prof. Fredrik Piehl, Principal Investigator of the study. “Fighting neurodegeneration that drives long-term multiple sclerosis disability is the critical unmet need with current treatment options, and we are pleased to see that the study corroborates findings of previous studies with temelimab.”
Although the small study size precluded statistical demonstration of treatment effects, the analyses showed a favorable impact of temelimab in preserving neocortical anatomy and myelin integrity. The effect sizes were of comparable magnitude to those previously observed in the CHANGE-MS and ANGEL-MS trials. The combined treatment of temelimab and rituximab protected against loss of cortical thickness by more than 50% relative to rituximab alone. Furthermore, cortical tissue integrity, as measured by magnetization transfer saturation, was improved with temelimab, potentially reflecting remyelination.
“We are excited by the results of the ProTEct-MS trial as an important step forward for temelimab in its path to treat MS patients in whom disability progresses despite effective control of inflammation and relapses,” commented Prof. David Leppert, M.D., Chief Medical Officer of GeNeuro. “We would like to thank all the study participants for their time and commitment to this important research effort, especially in the difficult circumstances of the pandemic during the past two years. We are also very grateful for the Karolinska Institutet’s Academic Specialist Center team whose dedication and commitment made this study possible.”
There was no upfront evidence of dose effect (18, 36 and 54 mg/kg doses compared with placebo) in the top-line results. Additional data from this study and from earlier trials need further analysis to define the optimal dose for future temelimab trials.
“Our key objective with ProTEct-MS was to show that temelimab could bring additional benefits on key markers of neurodegeneration in a population of MS patients already treated with a highly-effective anti-inflammatory drug. This objective has been met, as the data show the synergistic potential of targeting neurodegeneration on top of inflammation,” said Jesús Martin-Garcia, CEO of GeNeuro. “GeNeuro will now resume discussions with regulatory authorities and with potential partners to define the best development path combining temelimab and anti-neuroinflammatory treatments to bring the synergistic benefits of temelimab to patients.”
About GeNeuro
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
About the ProTEct-MS Phase 2 clinical trial
ProTEct-MS is a one-year clinical trial that enrolled patients whose disability progresses without relapses. 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). All patients in the trial received rituximab in the eight weeks preceding their enrollment in ProTEct-MS. The study was designed to assess safety, tolerability and efficacy measures based on the latest biomarkers associated with disease progression. The trial was conducted at Center for Neurology of ASC, the largest MS center in Sweden with approximately 2,400 patients.
Temelimab is a monoclonal antibody designed to neutralize a pathogenic retroviral envelope protein, pHERV-W Env. Positive results with temelimab have already been achieved in two clinical studies, CHANGE-MS and ANGEL-MS, using a dose of 18mg/kg.
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