Biopharmaceutical company Geneuro (Euronext Paris:GNRO) announced on Tuesday the completion of patient recruitment for its Phase 2 trial evaluating temelimab (GNbAC1) against long-COVID.
The trial, titled 'Temelimab as a Disease Modifying Therapy in Patients With Neuropsychiatric Symptoms in Post-COVID 19 or PASC Syndrome', involves a randomised, placebo-controlled, biomarker-based approach and has enrolled 203 patients across 14 clinical centres in Switzerland, Spain and Italy.
Focused on assessing the impact of temelimab on the clinical course of symptoms, including fatigue and cognitive impairment, all enrolled patients will receive six intravenous infusions of temelimab or placebo over 24 weeks. Notably, recruitment for the trial has revealed that over one third of patients with long-COVID syndromes screened positive for the presence of the pathogenic W-ENV protein in their blood. W-ENV is suspected to play a significant role in persistent inflammation and neurological symptoms in these patients.
The trial's objective is to determine the extent to which temelimab, a highly specific neutralising anti-W-ENV-antibody, can alleviate clinical symptoms in long-COVID patients. Success in this clinical endeavour could position temelimab as the first disease-modifying therapy for this underserved indication. Top-line results are expected by June 2024, potentially opening accelerated pathways for drug availability to the affected population.
Indivior updates on Aelis Farma's Phase 2B study of AEF0117 for Cannabis Use Disorder
Vesper Bio announces positive Phase I results for FTD treatment
Empower Pharmacy names new president
Innovent's IBI363 receives US FDA Fast Track Designation
Valneva and Pfizer report positive Phase 2 booster results for Lyme disease vaccine
Grit Biotechnology's GT201 receives US FDA IND approval
Cereno Scientific doses first patient in Expanded Access Program for PAH
Medicilon USA begins operations at second R&D centre in Massachusetts
CS Genetics names new chief operating officer and chief scientific officer
Expanse Medical names new chief executive officer and FlowPhysix board member