Incannex Completes Positive Pre-IND Meeting with US FDA on IHL-216A for Treatment of Concussion and Traumatic Brain Injury

Yesterday Incannex Healthcare Limited (ASX: IHL NASDAQ: IXHL) announced that it had completed a Positive Pre-IND Meeting with US FDA on IHL-216A for Treatment of Concussion and Traumatic Brain Injury (TBI). Incannex’s drug, named IHL-216A, is a combination of cannabidiol and isoflurane, which is an anesthetic. The purpose of the Pre-IND meeting was to make sure that the pathway which Incannex is following will allow the company to open an Investigational New Drug (IND) application with the FDA in the United States. Opening an IND is required to conduct trials in the United States and ensures that trials are designed to meet the data requirements necessary for FDA marketing approval.

Feedback from the FDA has indicated that they are very interested in the development of IHL-216A as a treatment for TBI. 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. This could result in a faster regulatory approval for the new drug because of the ability to use the data from previous trials of the components of the drug.

There is currently no drug on the market to treat traumatic brain injury so the opportunity for IHL would be very significant if the new drug is proven to be effective.