Incannex Healthcare - Constructive pre-IND FDA meeting for IHL-216A
Incannex has announced the completion of a pre-investigational new drug (IND) meeting with the US FDA for its proprietary inhaled drug product IHL-216A for the treatment of concussion and traumatic brain injury (TBI), following submission of the data package in August 2022. According to the company, the FDA has provided detailed feedback and guidance on the most efficient clinical trial development plan to effect successful commercialisation, in particular related to the complexities and specific requirements of developing an inhaled drug. As the next step, Incannex is preparing a follow-up request seeking additional information on the FDA’s recommendations. We see the current development as a positive step towards clinical development for IHL-216A. Our valuation remains unchanged at US$714.7m or US$11.74 per ADR, but we note the upside potential on successful clinical transition.
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