other_material
confidence high
sentiment neutral
materiality 0.55
Oragenics submits Phase II concussion trial protocol to NZ ethics committee
ORAGENICS INC
- Submitted clinical trial protocol to Health and Disability Ethics Committee (HDEC) in New Zealand for Phase II trial of ONP-002 for mild traumatic brain injury.
- Pending HDEC approval, expects to initiate patient enrollment at Christchurch Hospital, one of the busiest emergency departments in Australasia.
- ONP-002 is an intranasal neurosteroid therapy; no approved pharmaceutical exists for concussion, an unmet medical need.
- Phase I study showed safety and tolerability; Phase II will evaluate efficacy in mTBI patients.
- Company plans to expand global clinical footprint with sites in both Australia and New Zealand.