Incannex completes positive pre-IND meeting for traumatic brain injury candidate

Incannex Healthcare has completed a constructive pre-Investigational New Drug application (pre-IND) meeting with the US Food and Drug Administration (FDA) for its proprietary drug product IHL-216A for treatment of traumatic brain injury and concussion (TBI).

IHL-216A is Incannex’s proprietary combination of cannabidiol (CBD) and isoflurane (ISO) that is being developed for treatment of TBI. IHL-216A has 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 IHL-216A improved the effects of injury to a greater extent that either CBD or ISO monotherapy.

Incannex submitted a pre-IND meeting package to the FDA in August 2022. The meeting package included a description of the unique formulation developed by Incannex, an overview of the proposed clinical development plan and specific questions Incannex submitted on the regulatory requirements for opening an IND application. 

The company says in written correspondence, the FDA provided 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. The FDA also confirmed that the FDA505(b)2 application was the appropriate regulatory pathway for IHL-216A, whereby some of the information required for marketing approval may derive from studies already completed on the drug components of IHL-216A and in the public domain.

Incannex is currently drafting a follow-up request for additional information on the FDA’s recommendations and will provide an update to investor platforms when it has been received.

“Feedback from the FDA in the pre-IND meeting indicated that the agency is highly interested in the development of IHL-216A for treatment of TBI. Their responses covered all aspects of the proposed development and engaged a range of disciplinary experts that provided useful insight on all aspects of our development plan. The FDA has provided essential advice on inhaled drug development that will guide the most efficient development of IHL-216A,” said Dr Mark Bleackley, Chief Scientific Officer of Incannex.