Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL) has made additional progress with the development of its proprietary inhalable drug designed to treat brain injuries.
On Tuesday, the Australian pharmaceutical company announced that it had completed a productive pre-Investigational New Drug Application (pre-IND) meeting with the United States Food and Drug Administration (FDA) for its new drug, IHL-216A.
The CBD and isoflurane (anaesthetic) remedy from Incannex has shown positive pre-clinical results for treating concussions and traumatic brain injuries (TBI) in rodent studies and the recent feedback from the FDA will help the company on its way to advancing the drug into in-human trials.
— Incannex Healthcare (@ASX_IHL) October 10, 2022
The company says the FDA provided valuable written correspondence and “multidisciplinary feedback” on the proposed development of IHL-216A and reaffirmed that more innovative treatment options were needed for treating TBI.
The FDA confirmed that the company’s application method was appropriate for the drug and Incannex says it also received essential advice regarding the data requirements for developing an IND like IHL-216A, particularly related to the complexities of formulating an inhalable drug product and engaging in clinical trials involving the anaesthetic, isoflurane.
The news follows the company submitting a pre-IND meeting package to the FDA in August and announcing that it had partnered with Curia Global, Inc. to help accelerate production of IHL-216A and produce the first batch of the drug in accordance with Current Good Manufacturing Practice (cGMP).
That first tranche was intended to be used in a phase I clinical trial after receiving feedback from the FDA this quarter on the pre-IND application. However, based on the recent response from the FDA it does not appear that the company is ready for an in-human phase I trial just yet and more work will be involved prior.
Incannex says it is currently drafting a follow-up request for supplementary information regarding the recommendations from the FDA and that it will offer an update to ASX and Nasdaq investor platforms upon receiving a response.
“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,” said Mark Bleackley, chief scientific officer of Incannex.
“The FDA has provided essential advice on inhaled drug development that will guide the most efficient development of IHL-216A.”