IHL-216A Traumatic Brain Injury (TBI)
IHL-216A is a novel cannabinoid combination product for treatment of Traumatic Brain Injury (TBI).
IHL-216A is Incannex’s proprietary combination of cannabidiol (CBD) and isoflurane (ISO) under development for the treatment of concussion and traumatic brain injury (TBI). IHL-216A is an inhaled-drug product that has been designed to be administered soon after head trauma to reduce secondary brain injuries that lead to neurological deficits.
TBI accounts for approximately 10 million deaths and/or hospitalization annually in the world and there are no pharmaceutical agents approved for the treatment of TBI. 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.
The drug discovery team hypothesise that there is an optimal fixed dose of pharmaceutical ingredients within IHL-216A which, given soon after head trauma, will reduce: neuro-excitation, neuro-inflammation, cerebral blood flow and cerebral oxygen consumption with the result of providing overall neuroprotection, defined as reduced neuronal cell death or disruption. The consequences of neuroprotection will be improved recovery from the neurocognitive and motor deficits that result from concussion and TBI.
IHL-216A is designed to satisfy World Antidoping Authority (WADA) rules so that it may be used by elite athletes in sports related concussion and head trauma.
- In 2016 there were over 27 million incidences of TBI globally. (3)
- 70-90 % of TBI are mild in nature. (4)
- Global TBI treatment market is estimated to reach USD $ 156.8 billion by 2024 (5)
IHL-216A has been observed to have a strong neuroprotective effect in two distinct rodent models for traumatic brain injuries and sports-replicated concussion. IHL-216A compared to its component drugs, cannabidiol (CBD) and isoflurane, in a model developed in collaboration with the US National Football League, demonstrated that IHL-216A restored spatial memory after twenty-four hours in injured rodents. Injured rodents that only received the vehicle as treatment did not experience restoration in spatial memory. Treatment with CBD only partially restored spatial memory compared to IHL-216A, further supporting the benefits of Incannex’s patented novel drug combination compared to CBD alone.
Following these results, Incannex has undertaken a pre-IND meeting with the FDA. In written correspondence, FDA provided valuable, multidisciplinary feedback on the proposed clinical development of IHL-216A and acknowledged that treatment of TBI is a significant unmet medical need that requires innovative treatment solutions.
Incannex has engaged commercial drug manufacturing company, Curia Global to scale up cGMP fill-finish manufacture of IHL-216A. The engagement of Curia Global follows achievement of “proof-of-concept” formulation development and patent filing over the composition of IHL-216A. The first cGMP batch of IHL-216A manufactured at Curia Global will be used in a phase 1 clinical trial to assess the drug in healthy individuals.