Incannex Completes Positive Pre-IND Meeting With FDA On CBD-Based Drug For Treatment Of Rheumatoid Arthritis

Incannex Healthcare Limited IXHL IHL has completed a constructive pre-Investigational New Drug Application (‘pre-IND’) meeting with the U.S. Food and Drug Administration for its proprietary drug product IHL-675A for treatment of rheumatoid arthritis (‘RA’).

IHL-675A is Incannex’s proprietary combination product containing CBD and hydroxychloroquine sulfate for treatment of inflammatory disorders including RA. Incannex submitted a pre-IND meeting package to the FDA in June 2023.

The meeting package included a description of the formulation developed by Incannex, an overview of the proposed clinical development plan and specific questions Incannex submitted on the regulatory requirements for opening an Investigational New Drug (‘IND’) application. Opening an IND is required to conduct trials in the United States and ensures that trials are designed so that they meet the data requirements necessary for FDA marketing approval.

In the written correspondence, FDA provided valuable, multidisciplinary feedback on the proposed clinical development of IHL-675A. Importantly, the FDA confirmed that no further nonclinical studies are needed for the IND application.

The FDA also provided specific guidance on what is required for Incannex to submit an NDA via the 505(b)(2) pathway, whereby some of the information required for marketing approval is derived from published studies on the components of IHL-675A and/or the Agency’s findings on safety and/or effectiveness for relevant listed drugs.

The FDA provided critical guidance on the proposed clinical development plan for IHL-675A. Incannex is incorporating this guidance into clinical trial designs and the overarching strategy for development of IHL-675A.

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