Ghent University Hospital

ViGeneron's VG901 Receives FDA Rare Pediatric Disease Designation and Advances to Dose Escalation in Phase 1b Trial for Retinitis Pigmentosa

4 months ago

• The FDA granted Rare Pediatric Disease Designation to ViGeneron's VG901, a gene therapy for retinitis pigmentosa caused by CNGA1 gene mutations, highlighting the urgent need for new treatments. • VG901 leverages ViGeneron's vgAAV capsid to deliver the functional CNGA1 gene to retinal photoreceptor cells via intravitreal injection, offering a less invasive approach. • The Data Safety Monitoring Board (DSMB) has unanimously approved dose escalation in the ongoing Phase 1b clinical trial, indicating promising early safety results for VG901. • ViGeneron's VG801 receives FDA IND clearance for mRNA trans-splicing gene therapy to treat Stargardt disease and other retinal diseases associated with mutations in the ABCA4 gene.

Mepolizumab Demonstrates Sustained Efficacy in Chronic Rhinosinusitis with Nasal Polyps: Real-World Evidence

5 months ago

• Mepolizumab significantly reduced SNOT-22 and NPS scores in CRSwNP patients at 6 and 12 months, indicating improved quality of life and reduced polyp size. • Olfactory function, as measured by the Sniffin' sticks test, showed a statistically significant increase at both 6 and 12 months following Mepolizumab treatment. • All patients in the study continued Mepolizumab treatment at the 12-month follow-up due to reduced NPS, improved quality of life, and decreased need for systemic corticosteroids.

Osivax Initiates Phase 2a Booster Trial of Broad-Spectrum Influenza Vaccine OVX836

6 months ago

• Osivax has dosed the first participant in a Phase 2a clinical trial evaluating OVX836 as a booster for its broad-spectrum influenza vaccine candidate. • The trial assesses the safety and immunogenicity of a booster dose in participants previously vaccinated with OVX836 three to five years prior. • OVX836 targets the nucleoprotein, a conserved internal antigen of influenza A, aiming for a broader and more universal immune response. • Topline results from the randomized, double-blind study, conducted at Ghent University Hospital, are expected by the end of 2025.