Posted on Thursday, July 15, 2021
GeNeuro, a biopharmaceutical company developing new treatments for neurodegenerative diseases such as multiple sclerosis (MS), has announced the publication in the scientific journal Multiple Sclerosis of safety and efficacy results from the CHANGE-MS and ANGEL- clinical trials. MS with temelimab.
These studies were a 48-week, double-blind, Phase 2 trial (CHANGE-MS) in relapsing-remitting multiple sclerosis (RRMS), followed by a 48-week extension phase. (ANGEL-MS). These studies evaluated the safety and efficacy of temelimab on MRI markers of inflammation and neurodegeneration. A total of 270 patients were randomized to receive intravenous temelimab (6, 12 or 18 mg / kg) or placebo monthly for 24 weeks; at week 24, placebo-treated participants were re-randomized to the treatment groups. A total of 92% of RRMS patients who completed the CHANGE-MS study chose to continue the study and were included in the ANGEL-MS extension phase. Although the primary endpoint on acute inflammation was not met, as announced in August 2017, temelimab has already shown promising signs at 48 weeks on MRI markers of neurodegeneration (CHANGE-MS, top-line announced in March 2018), which were maintained or strengthened during the 48-week extension (ANGEL-MS, top-line announced in March 2019). No security problem arose.
These results uniquely position temelimab against neurodegeneration in MS, with the aim of treating the majority of patients whose disability continues to progress despite effective treatment against inflammatory flare-ups. The specific mode of action of temelimab, which neutralizes the pathogenic protein HERV-W ENV, and its excellent tolerance could pave the way for combinations to treat not only relapses but also neurodegeneration in MS.
“The publication of the results of the Phase 2 CHANGE-MS study and its 48-week ANGEL-MS extension confirms the potential of temelimab in MS through its new mechanism of action specifically targeting neurodegeneration. This was an ambitious exploratory Phase 2, for a new mechanism of action, and its promising results show the importance of pursuing new avenues to advance in the fight against the progression of disability, which remains a great medical need. in MS ”says Prof. Hans-Peter Hartung, Professor of Neurology at the Heinrich Heine University in Düsseldorf, and Principal Investigator of the CHANGE-MS and ANGEL-MS studies.
“Modern treatments for MS are very effective in reducing the activity of relapses, but have little effect on the long-term course of disability. CHANGE-MS and ANGEL-MS have demonstrated that the administration of temelimab is safe and has shown anti-neurodegenerative effects in patients, observed on radiological markers, at a dose of 18 mg / kg; it is therefore important to define the optimal dose for Phase 3. That is why we are eagerly awaiting the results of our final Phase 2 study conducted at the Academic Specialist Center at Karolinska Institutet / Stockholm, Sweden, with doses up to 54 mg / kg. This study recruited patients with MS whose acute inflammatory activity was neutralized by an anti-CD20 antibody with rituximab, but who continue to suffer from disease progression, ”says Professor David Leppert, Chief Medical Officer by GeNeuro.
As previously announced, the recruitment for the phase 2 clinical study ProTEct-MS (ClinicalTrials.gov: NCT04480307) of temelimab conducted at the Academic Specialist Center at Karolinska Institutet is fully completed and results are expected in the first quarter of 2022.
Source and visual: GeNeuro
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