XEN1101 Demonstrates Efficacy in Focal Epilepsy, Long-Term Profile of Inebilizumab, Combination of Epilepsy and MS Progress Worse


Neurology News Network for the week ending October 9, 2021. [WATCH TIME: 3 minutes]

WATCH TIME: 3 minutes

This week Neurology News Network covered the positive phase 2 results of XEN1101 in focal epilepsy, the 4-year long-term efficacy of inebilizumab, and how disease progression changes for patients with multiple sclerosis who also have epilepsy.

Welcome to this special edition of Neurology News Network. I’m Marco Meglio. Please excuse our appearance this week as a majority of the US workforce, including the NeurologyLive team, moves to working remote as we come together to help reduce the spread of the novel coronavirus.

Positive topline results from the phase 2b X-TOLE trial were announced by Xenon Pharmaceuticals, which evaluated XEN1101, a differentiated Kv7 potassium channel modulator for the adjunctive treatment of focal epilepsy in adults.The treatment demonstrated a statistically significant, dose-dependent reduction in monthly (28 days) focal seizure frequency from baseline, when compared to placebo, meeting the trial’s primary end point. Data showed a 52.8% reduction in monthly focal seizure frequency in the XEN1101 25-mg group, a 46.4% reduction in the 20-mg group, and a 33.2% reduction in the 10-mg group. Comparably, those in the placebo group experienced an 18.2% reduction. The trial also met its secondary end point, as 54.5% of patients had a 50% or greater reduction in monthly focal seizures when receiving 25 mg of XEN1101, compared to 14.9% of those receiving placebo. Of those receiving 20-mg and 10-mg doses of XEN1101, 43.1% and 28.3%, respectively, saw a 50% or greater reduction.

Recently published results from a post-hoc analysis from an open-label extension of the N-MOmentum trial showed that 4-year treatment with inebilizumab (Uplizna; Horizon Therapeutics) was safe and efficacious, with low annualized relapse rates (ARR) observed in patients with NMOSD who are seropositive for AQP4–IgG. At the time of the analysis, 75 participants in N-MOmentum received inebilizumab for at least 4 years, including 10 participants who originally received placebo during the randomized controlled period (RCP). A total of 18 attacks in 13 participants occurred after the initiation of study drug, resulting in an ARR of 0.052 (95% CI, 0.029-0.092) attacks/person–year. "These current findings support that inebilizumab may be effective in preventing long-term worsening disability associated with NMOSD," the study authors wrote.

Findings from a recent study published in the Multiple Sclerosis Journal show that secondary progressive disease course of multiple sclerosis (MS), age, and disability were associated with a 5-year prevalence of epilepsy. Data also showed that patients with both MS and epilepsy (MSE+) were more disabled in the first year of MS and had faster MS progression when compared to MS patients without epilepsy (MSE–) during a mean evaluation period of 17.6 years. Data showed a significant association between 5-year prevalence of epilepsy and increase in age, disease duration, and Expanded Disability Status Scale (EDSS) score (all P <.001). Epilepsy was associated with age MS disease duration and EDSS score.

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