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Clinical Trials IHL-216A | Traumatic Brain Injury/Concussion (‘TBI’) A novel cannabinoid neuroprotective drug given soon after head trauma

TBI is not treated effectively

IHL-216A is being assessed for its ability to protect the brain against the main injury mechanisms that cause cell death and other negative consequences in the days and weeks following head trauma, wherever it has been caused.

Clinical success will infer a wide array of implications and uses. Importantly, the Company will aggressively investigate the implications for a long-term Chronic Traumatic Encephalopathy (‘CTE’) prevention plan in contact sports in which CTE is prevalent.

TBI is associated with significant morbidity and mortality. Evidence for use of cannabinoids in treating brain trauma has been well publicised. It was demonstrated in the BM Nguyen, 2014 study that patients who presented to a trauma centre who also screened positive for cannabis had better survival outcomes than those who did not.

  • TBI is a major contributor to worldwide death and disability
  • There are upwards of 25 million cases of TBI reported every year
  • Moderate and severe TBI lead to substantial neurocognitive deficits
  • Incannex pursuing FDA registration of a TBI pharmacological treatment to prevent secondary injury cascades after head trauma

IHL-216A for Concussion/Traumatic Brain Injury (‘TBI’) and CTE

IHL-216A is a combination cannabinoid drug to be administered in the immediate period after primary blunt head injury. Incannex is assessing its ability to protect the brain against secondary injury mechanisms that cause neuronal cell death and raised intracranial pressure in the days and weeks following head trauma in sports, and all other applicable scenarios resulting in head trauma (falls, vehicle collisions, violence, combat etc.).

Ablating secondary brain injury may improve positive outcomes for long term neurological sequelae including chronic traumatic encephalopathy (‘CTE’), a major health risk associated with contact sports e.g. MMA, NFL, AFL and NRL.

Incannex has filed patents covering key aspects of IHL-216A to be used as a neuroprotective agent administered post-head trauma. The IHL drug discovery team believes that an optimal fixed dose of APIs within IHL-216A will result in the provision of neuroprotection, defined as reduced neuronal cell death and damage.

Incannex is currently undertaking a comprehensive animal study to formally assess the neuroprotective capability of IHL-216A. The trial introduces rodents to head trauma, implemented consistently in a highly controlled environment to inflict a reproducible injury. Eight separate rodent cohorts will be administered components or combinations of IHL-216A at varying doses soon after the trauma. The rodents will then undertake behavioural tests at various intervals to assess their neurocognitive and motor function. Incannex will also monitor secondary injury cascades, assess structural damage to the brain using magnetic resonance imaging and perform micro-scale cellular analysis post-mortem to discern and compare neuronal damage across the cohorts.

The study is being conducted to discern optimal combination dosages for the upcoming in-human clinical trial in MMA fighting athletes and will contribute to the Company’s FDA data package. IHL-216A is designed to satisfy World Antidoping Authority (‘WADA’) and Australian Anti-Doping Authority’s (‘ASADA’) specifications for use by athletes at risk of TBI and CTE.

Incannex’s animal study being undertaken now and the future MMA fighters clinical trial will contribute to a FDA 505(b)(2) new drug application for exclusive marketability; details of which were released in the announcement on the 03rd of March 2020 and entitled, “IHL-216A (TBI/Concussion) accelerated FDA approval pathway”.

What is Concussion/Traumatic Brain Injury (TBI)?

A concussion is a traumatic brain injury that affects your brain function. Mild symptoms include; loss of consciousness, headache, nausea, fatigue, sensory and cognitive problems.

Complications can occur immediately or soon after a traumatic brain injury. Some complications include:

  • Seizures
  • Vertigo
  • Cognitive problems
  • Executive functioning deficits
  • Social, emotional and behavioural changes.

What are the causes of Traumatic Brain Injury?

TBI are caused by a rapid acceleration/deceleration of the brain caused by a direct blow to the head or sudden impact to the body that jolts the skull.

This causes the brain to compress against the skull. The impact of the brain against the skull causes both macro and micro scale damage to the brain which sets of a series of physiological events called secondary injury cascades. These secondary injury cascades are what cause many of the neurocognitive deficits seen in TBI patients.

Falls, vehicle collisions, violence, sports and combat injuries are the main activities leading to TBI and concussion.

The signs and symptoms of a concussion can be subtle and may not show up immediately. Symptoms can last for days, weeks or even longer.

Common symptoms after a concussive traumatic brain injury are headache, loss of memory (amnesia) and confusion. The amnesia usually involves forgetting the event that caused the concussion.

Other symptoms include, nausea, vomiting, fatigue, blurry vision and ringing in the ears.

Traumatic brain injury accounts for approximately 10 million deaths and/or hospitalisation annually in the world

  • There’s approx 2.87 million TBI in the US alone in one year
  • 812,00 cases occurring among children
  • The number of total TBI-EDHDs increased by 53% from 2006 to 2014
  • 56,800 TBI-related deaths, including 2,529 occurring among children
There are currently no pharmaceutical agents approved for the treatment of TBI. IHL-216A is a world first concept

Current treatment of major TBI is primarily managed through surgical intervention by decompressive craniotomy (Bullock et al., 2006) which involves the removal of skull segments to reduce intracranial pressure.