Marco Meglio, Assistant Managing Editor for NeurologyLive, has been with the team since October 2019. Follow him on Twitter @marcomeglio1 or email him at mmeglio@neurologylive.com
Cell Therapy Bemdaneprocel Advances to Phases 3 Registrational Trial in Parkinson Disease
January 15th 2025The newly announced sham surgery-controlled trial will include 102 patients with moderate PD testing several end points, such as change in ON-time without troublesome dyskinesia, over a 78-week period.
NeuroVoices: Nigel Bunnett, PhD, BSc, on Identifying a Novel Therapeutic Target for Chronic Pain
January 15th 2025The professor and chair of the Department of Molecular Pathobiology at NYU College of Dentistry discussed groundbreaking research on chronic pain, focusing on the discovery of new mechanisms involving nerve growth factor and its receptors.
FDA Accepts BLA for Subcutaneous Autoinjector Formulation of Lecanemab
January 14th 2025In the pivotal phase 3 Clarity AD trial, treatment with a subcutaneous autoinjector of lecanemab led to reduced rates of amyloid-related imaging abnormalities while maintaining similar bioequivalence levels to the original formulation.
Phase 1b PRECISE-AD Trial of Oligomer-Targeting Agent PMN310 Gets Underway
January 14th 2025Eligible participants are ambulatory adults aged 50 or older with mild cognitive impairment or mild Alzheimer disease, confirmed by clinical assessments and a positive amyloid PET scan, and who meet specific health and safety criteria.
Optimizing Epilepsy Treatments: Stiripentol’s Role in Dravet Syndrome
January 13th 2025James Wheless, MD, FAAP, FAAN, FAES, Le Bonheur Chair in Pediatric Neurology at the University of Tennessee Health Science Center, shared insights on his presentation from AES 2024, focusing on stiripentol, an FDA-approved treatment for Dravet syndrome.
Epilepsy Agent RAP-219 Shows Promising Safety, Target Occupancy Across Phase 1 Studies
January 12th 2025An ongoing phase 2a study of RAP-219 involves adult patients with drug-resistant epilepsy who have an implanted responsive neurostimulation (RNS) device, allowing for real-time monitoring of intracranial EEG data.
Rising Clinical Utility of Plasma P-Tau217 in Diagnosing Alzheimer Disease
January 9th 2025Masoud Toloue, chief executive officer at Quanterix, and Nicholas J. Ashton, PhD, senior director of the Banner Health Fluid Biomarker Program, discussed the Simoa technology required to test for p-tau217, the expanding understanding of this biomarker, and the next steps for advancing this research.
FDA Grants Fast Track Designation to Anti-Tau Therapy Posdinemab
January 9th 2025Posdinemab, a monoclonal antibody that targets the mid-domain of Alzheimer disease-specific phosphorylated tau, is currently being investigated in a placebo-controlled phase 2b trial that employs a plasma biomarker as a screening tool.
FDA Clears IND for Trial Assessing Gene Therapy SGT-212 in Friedreich Ataxia
January 8th 2025SGT-212 delivers full-length frataxin via MRI-guided intradentate nucleus infusion and intravenous administration to target mitochondrial dysfunction in neurons and cardiomyocytes, addressing both neurologic and cardiac symptoms.
Stoke Announces Phase 3 EMPEROR Registrational Study for Zorevunersen in Dravet Syndrome
January 8th 2025The global Phase 3 trial aims to enroll ~150 patients with Dravet syndrome who have SCN1A variants, assessing zorevunersen's impact on seizure frequency, behavior, cognition, and safety over 60 weeks, with results expected by 2027.
Reducing the Burden: Proactive Care Strategies for Lennox-Gastaut Syndrome
January 7th 2025Babitha Haridas, MD, MBBS, a pediatric epileptologist at Johns Hopkins Medicine, discussed the complexities with managing status epilepticus in Lennox-Gastaut syndrome, focusing on the importance of identifying triggers early in their condition.
Axsome to Submit NDA for AXS-05 in Alzheimer Agitation Following Positive Phase 3 Trials
January 6th 2025The ACCORD-2 trial demonstrated a significant reduction in overall worsening compared to placebo, while the ADVANCE-2 trial showed numerically greater improvements without reaching statistical significance.
Expanding the Clinical Care of Friedreich Ataxia Through Omaveloxlone and SKYCLARYS PASS Registry
January 4th 2025David Lynch, MD, PhD, a professor of neurology at the University of Pennsylvania Perelman School of Medicine, discussed the significance of a number of recently presented analyses highlighting omaveloxlone, the first approved therapy for Friedreich ataxia.