Odyssey Health has reported positive data from Cohort I of the multi-day ascending dosing (MAD) arm of the Phase I clinical trial analysing its new drug, PRV-002, to treat concussion.
The Phase I MAD trial is underway evaluating PRV-002 in 16 healthy human participants.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
It is being carried out by clinical research organisation Avance Clinical, through Nucleus Network, which is a Phase I trial provider with various sites in Australia.
Previously, the Phase I SAD arm of the drug was completed and found to be well-tolerated.
MAD Cohort I participants received the drug for five successive days.
Cohort I of MAD enrolled eight subjects, who received one low intranasal dose of PRV-002 and underwent subsequent analyses for abnormal responses.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataAccording to the safety findings, PRV-002 was found to be safe and well tolerated in this cohort.
Furthermore, no severe adverse events were reported.
A synthetic neurosteroid, PRV-002 is being developed to treat mTBI (concussion).
PRV-002 showed neuroprotective effects in line with, if not superior to neurosteroids in preclinical studies.
In animal concussion models, PRV-002 was found to lower the behavioural pathology linked to brain injury symptoms such as impairment in memory, motor/sensory performance and anxiety.
Odyssey Health drug development head Dr Jacob VanLandingham said: “PRV-002 appears to be well-tolerated when given intranasally.
“If PRV-002 is found to be efficacious for concussed patients in the Phase II/III trials, I believe that intranasal brain-targeting will be the key to its success.
“So far, the intranasal drug/device combination has functioned nicely and has been well-tolerated in the clinical setting.”
