other material
confidence high
sentiment positive
materiality 0.60
Oragenics' concussion drug ONP-002 passes FDA cardiotoxicity test, Phase II planned
ORAGENICS INC
- ONP-002 showed no cardiotoxicity in GLP hERG study conducted by Charles River Laboratories.
- Inhibitory concentration >10 µM; large cardiac safety margin based on Phase I plasma levels.
- Phase II trial planning underway to evaluate ONP-002 in concussed patients.
- Concussion market estimated at 69M cases globally; annual US healthcare cost for TBIs exceeds $40.6B.
- ONP-002 is an intranasal neurosteroid new chemical entity targeting mild traumatic brain injury.