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Verdiperstat Fails ALS Study, Lecanemab Shines in Latest Phase 3 Findings, Ofatumumab Continues Superiority Over Teriflunomide

Neurology News Network for the week ending October 1, 2022. [WATCH TIME: 4 minutes]

WATCH TIME: 4 minutes

Welcome to this special edition of Neurology News Network. I’m Marco Meglio.

Verdiperstat, Biohaven’s investigational first-in-class potent, selective, brain-penetrant, irreversible MPO enzyme inhibitor, failed to statistically differentiate from placebo in newly announced findings from the pivotal HEALEY ALS Platform Trial the first-ever platform trial in ALS.In a brief company update, it was noted that the agent did not reach statistically significant differences on the prespecified primary outcome, disease progression, as measured by ALS Functional Rating Scale-Revised (ALSFRS-R), survival, and other key secondary measures. The safety profile of verdiperstat appeared to be similar to previous clinical trials. The full results of the study are expected to be presented at an upcoming scientific conference, according to Biohaven. Of the 5 investigational agents being evaluated, regimen B included verdiperstat. This specific substudy of the platform trial included 160 participants with ALS who were randomly assigned 3:1 to either verdiperstat 600-mg oral tablet twice daily or placebo for 24 weeks. In addition to ALSFRS-R, other secondary end points included change in respiratory function, muscle strength, and survival.

Lecanemab, previously known as BAN2401, reduced the decline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) by 27% compared with placebo from baseline to month 18 for participants with early Alzheimer disease (AD; P = .00005), according to positive topline results from the phase 3 Clarity AD trial announced by Eisai and Biogen, the developers of the humanized monoclonal antibody that eliminates toxic amyloid-ß protofibrils.Ultimately, the reduction represented a treatment difference in the CDR-SB score change of –0.45 between the groups. Notably, the companies announced that the FDA agreed that the results of Clarity AD may serve as confirmatory data to verify the clinical benefit of lecanemab. As such, the companies are seeking traditional FDA approval as soon as possible, submitting the application via the accelerated approval pathway to allow for review with the exception of the data from the confirmatory Clarity AD study. More data are expected to be announced at the Clinical Trials in Alzheimer’s Disease (CTAD) meeting in late November, including those on safety and representation.

Post hoc findings from the phase 3 ASCLEPIOS I and II studies showed that ofatumumab was superior to teriflunomide on a number of outcomes, including annualized relapse rate (ARR) and confirmed disability worsening (CDW), among patients with recently diagnosed, treatment-naïve (RDTN) multiple sclerosis (MS).All told, those treated with the B-cell targeting agent had an ARR of 0.09, otherwise a 50% greater reduction than those on teriflunomide. Additionally, ofatumumab reduced the risk of 3-month CDW numerically by 38% and of 6-month CDW by 46% relative to teriflunomide. Senior author Ludwig Kappos, MD, professor of neurology, University of Basel, and colleagues, concluded that “these findings are consistent with those observed in the overall ASCLEPIOS population and show that ofatumumab can delay disability worsening in early MS.” They added that these data continue to support the use of ofatumumab as a first-line treatment for this patient population.

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