other material
confidence high
sentiment neutral
materiality 0.55
Oragenics completes spray-dry manufacturing of ONP-002 for Phase IIa concussion trial
ORAGENICS INC
- ONP-002 produced as spray-dried nanoparticle powder and filled in Oragenics' breath-propelled intranasal device.
- Phase IIa trial to enroll 40 concussed patients (1:1 placebo/ONP-002), dosed twice daily for 5 days starting within 8 hours of injury in ED.
- Trial will be conducted in Australia; patient-reported outcomes and blood biomarkers included in evaluation.
- No approved pharmaceutical treatment for concussion; ONP-002 is a novel neurosteroid designed as first-in-class therapy.