GeNeuro’s Temelimab Shows Extended Neuroprotective Effects in Relapsing-Remitting MS
GeNeuro (Paris:GNRO) (Euronext Paris: CH0308403085 - GNRO), a biopharmaceutical company developing new treatments for neurodegenerative and autoimmune diseases, such as multiple sclerosis (MS) and type-1 diabetes (T1D), today announced that the neuroprotective effects of temelimab in MS patients extend to 96 weeks and that it is safe to use and well tolerated for a prolonged period. These data, from ANGEL-MS, an extension of the Phase 2 CHANGE-MS trial in relapsing-remitting MS (RRMS), were presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS 2019) Congress in Stockholm, Sweden.
Temelimab is a monoclonal antibody designed to neutralize a pathogenic envelope protein, pHERV-W Env, which is encoded by a member of the Human Endogenous Retrovirus W family. This protein plays a causal role in the development of MS and is thought to also be a key factor in the onset and development of T1D.
Patients with RRMS who completed the CHANGE-MS study were included in the ANGEL-MS study, from 43 centers across 12 countries. Overall, 220 patients from CHANGE-MS (95% of those who completed the study) entered the extension, with 75 patients, 68 patients and 77 patients enrolled to receive temelimab 6 mg/kg, 12 mg/kg and 18 mg/kg monthly IV infusions, respectively.
The data showed that, after two years of treatment, patients originally randomized to temelimab (18 mg/kg) in CHANGE-MS show evidence in ANGEL-MS for continued relative improvements in MRI-based neurodegenerative outcomes, such as brain volumes, magnetization transfer ratio (MTR) and black holes during ANGEL-MS up to 96 weeks compared to all other groups. In the combined CHANGE-MS and ANGEL-MS treatment periods (total of 96 weeks), the reduction in the atrophy rate of the cerebral cortex between patients treated at 18mg/kg over the entire period versus the control group was 42% (dose effect1 p=0.058) and the reduction in the atrophy rate of the thalamus was of 43% (dose effect1 p=0.038). Temelimab also had a marked effect on myelin integrity, as measured by Magnetization Transfer Ratio (MTR), with an increase in MTR values by >1.5% over the period, both in cortical (p<0.03 in all bands) and normal appearing white matter (p<0.02 in all bands). Importantly, these effects were not driven by an anti-inflammatory effect. These data supplement the initial findings from ANGEL-MS announced in March 2019: http://www.geneuro.com/data/news/P1379-Ectrims-2019.pdf