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. 

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. 

According 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.”