GeNeuro announced that the primary analysis of the Phase 2 ProTEct-MS trial was presented at the meeting of the European Committee for the Treatment and Research of Multiple Sclerosis (ECTRIMS 2022) in Amsterdam, The Netherlands, by Dr. Fredrik Piehl, Professor of Neurology in the Department of Clinical Neuroscience at the Karolinska Institutet, Head of Research at the MS Clinic at the Academic Specialist Center (ASC) and Principal Investigator of the study.
The ProTEct-MS study involved a very homogeneous cohort of 42 patients treated with temelimab (18, 36 and 54 mg / kg) compared to placebo for 48 weeks. The patients included in the study had confirmed the progression of disability without relapse, after previous treatment with rituximab, an anti-CD20 drug, very powerful and effective against relapse and the formation of brain lesions. The one-year phase 2 study conducted at ASC Karolinska Institutet in Stockholm, Sweden evaluated the administration of temelimab to patients with relapsing-remitting MS for the treatment of disease progression regardless of relapse after treatment with rituximab. .
The data presented show that after one year of treatment, temelimab appears to be a safe complement to anti-CD20 therapy. The drug was well tolerated: there were no treatment interruptions, no serious or serious treatment-related adverse events, and no difference in overall clinical or laboratory safety results, meeting the primary study endpoint of the drug.
As announced in the main results of March 2022, MRI biomarkers showed a favorable impact of temelimab in the preservation of neocortical anatomy and myelin integrity. The effect size was comparable in magnitude to those previously observed in the previous CHANGE-MS and ANGEL-MS studies. Combined treatment of temelimab and rituximab protected the loss of cortical thickness by more than 50% compared to rituximab alone. Additionally, cortical tissue integrity, as measured by magnetization transfer saturation, was enhanced by temelimab, which can reflect remyelination.
New exploratory data on soluble biomarkers were presented, as measures of neurodegeneration at one year: the study showed a reduction of biomarkers GFAP and NfL in cerebrospinal fluid (CSF). GFAP is a biomarker of astrocyte activation associated with widespread neuroaxonal damage leading to the progression of MS. Patients treated with temelimab and rituximab after 48 weeks had a mean reduction of 2.5% in GFAP, compared with a mean increase of 2.5% for those receiving rituximab alone. Measurement of CSF NfL, another established marker of neuroaxonal damage in MS related to disease progression, also showed a relative reduction of 33% in patients treated with temelimab and rituximab compared to patients treated with rituximab alone. Results on these CSF biomarkers confirm synergistic potential in the treatment of neurodegeneration with temelimab as well as highly effective anti-inflammatory treatment in MS.
“We are thrilled with the results of the ProTEct-MS study, which represent a major step forward for temelimab in its journey of treating MS patients whose disability progresses despite effective control of inflammation and exacerbations, which is the critical unmet need. with current treatment options, ”commented Prof. David Leppert, MD, Medical Director of GeNeuro. We thank all study participants for their time and commitment in this important research effort, especially in the difficult circumstances of the study. pandemic in the last two years. We are also very grateful to the team at the Academic Specialist Center of the Karolinska Institutet, whose dedication and commitment made this study possible. “
Source and view: GeNeuro