This could be huge news, as TBI is responsible for roughly "10 million deaths and/or hospitalizations" globally each year, and there are currently no registered pharmaceutical agents approved for its treatment.
The Australian pharmaceutical company, Incannex Healthcare Limited (ASX: IHL), announced this week that it had received positive results from its preclinical in vivo (animal) studies in relation to the neuroprotective capability of IHL-216A.
The in vivo trials were conducted by Creative Biolabs (USA) and were focused on examining IHL-216A's efficacy in reducing secondary brain injuries—which can cause neurological deficits—if administered soon after head trauma.
The results of the animal study are extremely pleasing and steadfastly demonstrate significant improvements in the key markers of secondary brain injury in a highly-controlled environment. Our intent is for IHL-216A to be the first line of defence to dampen the short and long-term effects of traumatic brain injury caused by any means, but particularly in contact sports, such as the NFL and the major contact sporting codes in Australia where CTE is a growing concern.Incannex Healthcare CEO and Managing Director, Joel Latham
According to a statement from the company, the study employed a rat controlled cortical impact (CCI) model of traumatic brain injury. This involved first inducing a Traumatic Brain Injury (TBI) in the rats by performing a craniotomy—removing a small section of bone from the skull—before impacting the exposed brain with a pneumatic rod.
The test subjects were then subsequently treated with CBD and isoflurane—separately and in conjunction—using the same dosage rate.
Isoflurane was ingested by the rats via inhalation for a 30 minute period, approximately 1-2 hours after injury, on the day that the brain trauma occurred. CBD was administered by intraperitoneal injection every day—for a seven-day period post TBI—with the initial dose being administered 15-30 minutes following the craniotomy.
The study featured a total of 108 rats, including a vehicle treated control group and sham-injured group where the craniotomy—but not pneumatic rod-induced injury—was performed, to account for possible variables.
The drug was also designed to meet the regulations set out by the World Antidoping Authority (WADA) and Australian Anti-Doping Authority (ASADA), that govern its use by athletes at risk of TBI and Chronic Traumatic Encephalopathy (CTE).
This could be huge news, as TBI is responsible for roughly "10 million deaths and/or hospitalization" globally each year, and there are currently no registered pharmaceutical agents approved for its treatment.
Incannex has confirmed that it is currently determining the most efficient approach for a clinical trial program—with a projected start date in early 2021—pursuant to the eventual end goal of completing an FDA new drug application as expediently as possible.
Disclaimer: Past performance is not an indicator of future performance.
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