Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL) has presented its pre-Investigational New Drug Application (pre-IND) for traumatic brain injury and concussion (TBI) treatment IHL-216A in a constructive meeting with the US Food and Drug Administration (FDA) which provided valuable, multidisciplinary feedback.
IND designations are required to begin clinical trials in the US, ensuring trials are designed to meet the data requirements necessary for FDA marketing approval.
IHL-216A is a proprietary combination of cannabidiol (CBD) and isoflurane (ISO) that Incannex is developing for the treatment of TBI.
The company submitted a pre-IND meeting package to the FDA in August 2022.
This meeting package included a description of Incannex’s formula, an overview of the proposed clinical development plan and specific questions on the regulatory requirements for opening an IND application.
Essential guidance for development
“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 traumatic brain injury,” Incannex Healthcare chief scientific officer Dr Mark Bleackley said.
“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.”
The administration also confirmed that the company was on the correct regulatory track and highlighted that public domain studies completed on the individual components of IHL-216A would help fast-track marketing approval.
In May this year, Incannex released the results of an extensive animal study that compared IHL-216A to its component drugs, CBD and ISO, in a model developed in collaboration with the US National Football League (NFL).
Read: Incannex Healthcare's IHL-216A treatment observed to have neuroprotective effect in rodent model of sports concussion
In that experiment, IHL-216A was observed to restore spatial memory after 24 hours in injured rodents, while injured rodents that only received the vehicle as treatment did not display restored spatial memory.