US-based biopharmaceutical company Prevacus is planning to initiate a Phase I clinical trial of PRV-002 to treat concussion / mild traumatic brain injury (mtbi) in the first half of this year.
PRV-002 is a fully synthetic, non-naturally occurring neurosteroid administered via the nasal cavity, designed to minimise behavioural pathology related to brain injury symptoms such as memory impairment, anxiety, and motor / sensory performance.
The drug is lipophilic and claimed to easily cross the blood-brain barrier to rapidly remove swelling, oxidative stress and inflammation.
The Phase I trial will evaluate the drug's ability to alleviate the adverse effects of the concussion.
Prevacus chief executive officer Jake VanLandingham said: "I am excited with the progress we've made in advancing PRV-002, our novel treatment for mTBI.
"Concussion presents a significant, unmet medical need, and our PRV-002 compound has the potential to reduce the adverse effects associated with mTBI in athletes, military personnel and civilian patients while improving the quality of life, thereby saving the US healthcare system significant costs.”
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A concussion is a type of traumatic brain injury caused by a significant force to the head or upper body, leading to a change in mental status such as amnesia, disorientation, mental fogginess, confusion, nausea / vomiting, blurred vision, headache, balance deficits or loss of consciousness.
No two concussions are exactly alike, which results in requirement for a compound that can decrease multiple pathological issues.
The pre-clinical animal studies of the drug showed positive results in all measured areas such as memory score, sensory-motor function, anxiety, cerebral edema, cell death and cellular regeneration.