Higher doses of temelimab used together with rituximab have excellent safety and tolerability profile in patients with relapsing forms of multiple sclerosis (MS), according to the results of the phase 2 ProTEct-MS clinical trial. This means that the trial met its primary endpoint.

“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 Fredrik Piehl, MD, PhD, the principal investigator of the study.

“Fighting neurodegeneration that drives long-term [MS] 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.”


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The randomized, double-blind, placebo-controlled trial enrolled 41 patients with MS treated with rituximab but whose disability was worsening. They were given 18 mg/kg, 36 mg/kg, or 54 mg/kg of temelimab or a placebo as monthly intravenous infusions over 48 weeks.

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The primary outcome measure was safety and tolerability measured by adverse events. Secondary outcome measures included changes in T1 and T2 lesion volume at week 48 compared to baseline.

The results showed that temelimab was well-tolerated with no discontinuations related to the treatment, no serious or severe treatment-emergent adverse events, and no differences in overall clinical or laboratory safety findings. Efficacy findings showed that the treatment had a beneficial trend on key parameters of neurodegeneration.

“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,” David Leppert, MD, chief medical officer of GeNeuro said.

The company will now resume discussions with regulatory authorities and potential partners to bring the potential benefits of temelimab to patients, Jesús Martin-Garcia, the chief executive officer of GeNeuro said.

Temelimab is an immunoglobulin G4 monoclonal antibody that targets the human endogenous retroviral envelope protein, which is associated with MS.

References

ProTEct-MS phase 2 trial confirms safety of higher doses of temelimab and synergistic potential to address neurodegeneration on top of anti-inflammatory treatment in multiple sclerosis. News release. GeNeuro. March 21, 2022.

Clinical trial assessing temelimab following rituximab treatment in patients with relapsing forms of multiple sclerosis (ProTEct-MS). US National Library of Medicine. Updated September 1, 2021. Accessed March 28, 2022.