Incannex Healthcare completes US FDA meeting for IHL-216A in treating traumatic brain injury
Clinical-stage pharmaceutical company Incannex Healthcare (ASX: IHL) has completed a pre-investigational new drug (IND) application meeting with the US Food and Drug Administration over IHL-216A, its proprietary drug for treating traumatic brain injury (TBI) and concussion.
IHL-216A is a combination of cannabidiol and isoflurane designed to be administered via inhalation soon after head trauma to reduce secondary brain injuries which could lead to neurological deficits, including chronic traumatic encephalopathy (CTE) resulting from repeated head blows in contact sports.
In August, Incannex submitted a pre-IND meeting package to the FDA which included a description of the unique formulation, an overview of the proposed clinical development plan and specific questions relating to regulatory requirements.
An IND is required before the company can conduct US trials and ensures the studies are designed to meet the data requirements necessary for FDA approval.
Incannex said the FDA provided “valuable, multi-disciplinary feedback” on the proposed clinical development of IHL-216A and acknowledged that treatment of TBI is a significant unmet medical need which requires innovative treatment solutions.
It provided guidance on the data requirements for opening an IND for IHL-216A, particularly in relation to the development of an inhaled drug product and conducting clinical trials which involve an anaesthetic.
Incannex chief scientific officer Dr Mark Bleackley said FDA feedback had been valuable to guiding the IHL-216A development plan.
“It indicates that the agency is highly interested in the development of IHL-216A for treatment of traumatic brain injury,” he said.
“The responses covered all aspects of the proposed development and engaged a range of disciplinary experts who provided useful insight on all aspects of our development plan.”
Incannex is currently drafting a follow-up request for additional information on the FDA’s recommendations.
IHL-216A has previously demonstrated neuroprotective activity in two separate animal models of TBI, one representing moderate to severe injury and the other representing mild injury or concussion.
In both models, treatment with the drug improved the effects of injury to a greater extent than cannabidiol or isoflurane monotherapy.
In May, Incannex released the results of an extensive animal study comparing IHL-216A to its component drugs cannabidiol and isoflurane in a model developed in collaboration with the US National Football League.
In that experiment, IHL-216A was observed to restore spatial memory after 24 hours in injured rodents.
Injured rodents that received only the vehicle as treatment did not display any restoration.