News CHANGE-MS Phase 2 Study Fully Enrolled Early, Results Due in Fall CHANGE-MS Phase 2 Study Fully Enrolled Early, Results Due in Fall by Joana Fernandes, PhD | January 5, 2017 Share this article: Share article via email Copy article link GeNeuro recently announced that it has finished enrolling multiple sclerosis (MS) patients in the CHANGE-MS Phase 2b Ā studyĀ ā several months ahead of schedule.Ā The company nowĀ expects to reportĀ topline results in mid- to late autumn rather than at year’s end. āCompleting enrollment in CHANGE-MS several months sooner than previously anticipated is a significant achievement for our GNbAC1 development program and, most importantly, accelerates the timeline to potentially provide MS patients with a new and effective therapeutic option,ā GeNeuroās CEO, JesĆŗs Martin-Garcia, saidĀ in a news release. The CHANGE-MS (NCT02782858) study is evaluating the effect of GNbAC1 on 260 patients with relapsing-remitting multiple sclerosis (RRMS). Patients were enrolled at multiple clinical sites across Europe. Its goal is to evaluate whether GNbAC1 can reduce RRMS patients’ active brain lesionsĀ ā assessed through magnetic resonance imaging (MRI) ā at six months and one year after treatment, comparedĀ to placebo. GNbAC1 is a selective antibody that targets the protein MSRV-Env, which promotes inflammatory processes and the development of diseases such as MS. MSRV-Env is known to be present in brain lesions and in the blood of MS patients. By targeting the protein, GNbAC1 decreases inflammation and potentially promotes the remyelination of neurons. GeNeuro and Servier alsoĀ recently announced that patients will be able to continue their therapy with GNbAC1 for two more years in an extension study called ANGEL-MS, allowing researchers to collect more data on the treatment’s safety and efficacy profiles. This study is scheduled to enroll a first CHANGE-MS patient in April. GeNeuro plans to start another GNbAC1 study, specifically enrolling secondary progressive MS patients in the United States, in the second half of this year. The study will investigate whether treatment with GNbAC1 can induce changes in biomarkers of inflammation, remyelination, and neuroprotection. ā2016 has been a transformative year for GeNeuro, with … the full recruitment of CHANGE-MS and the further strengthening of our team in order to execute additional clinical trials in 2017,ā Martin-Garcia said. āWe look forward to initiating these new studies and to the availability of the interim 6-month results from CHANGE-MS at the beginning of the fourth quarter of 2017.ā Print This Page About the Author Joana Fernandes, PhD Joana brings more than 8 years of academic research and experience as well as Scientific writing and editing to her role as a Science and Research writer. She also served as a Postdoctoral Researcher at the Center for Neuroscience and Cell Biology in Coimbra, Portugal, where she also received her PhD in Health Science and Technologies, with a specialty in Molecular and Cellular Biology. Tags antibody, CHANGE-MS, enrollment, GeNeuro, GNbAC1, inflammation, neuroprotection, remyelination, Servier
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