Australian cannabinoid developer Incannex Healthcare said that its pre-IND meeting with the FDA regarding its IHL-216A inhaled CBD/isoflurane for the treatment of traumatic brain injury was “constructive.” In June 2021, Incannex signed an agreement with inhalation CDMO Vectura for preclinical development services for IHL-216A.
The company said at that time that Monash University researchers were conducting studies of IHL-216A. In May 2022, Incannex reported that the Monash study found that treatment with IHL-216A restored spatial memory 24 hours post injury better than CBD alone in a rat model of sports concussion injury.
According to the company, the FDA written response following the pre-IND meeting “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” and “provided critical guidance on the data requirements for opening an IND for IHL-216A, particularly related to the intricacies of developing an inhaled drug product and conducting clinical trials that involve an anesthetic.”
Incannex Chief Scientific Officer Mark Bleackley commented, “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. 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.”
Read the Incannex press release.
