Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL) has completed a constructive pre-Investigational New Drug (IND) application meeting with the US Food and Drug Administration (FDA) for its IHL-675A proprietary drug targeted at the treatment of rheumatoid arthritis (RA).
IHL-675A is a combination of cannabidiol (CBD) and hydroxychloroquine sulphate designed to address inflammatory disorders including RA.
A successful IND application is a requirement to conduct trials in the United States and ensures trials are designed to meet data requirements for future FDA approvals.
"Highly valuable"
“Feedback received from the FDA in the pre-IND meeting is highly valuable for the continued development of IHL-675A for treatment of rheumatoid arthritis,” Incannex chief scientific officer Dr Mark Bleackley said.
“The agency’s responses covered multiple aspects of our development strategy that will be incorporated into our clinical trial designs and research plans.
“We look forward to continuing to work with the FDA to ensure that the IHL-675A development program generates high-quality data that addresses the requirements set forth by the agency.”
Details of the IND application
The company submitted a package to the FDA with a description of the unique formulation developed by Incannex, an overview of the proposed clinical development plan and specific questions Incannex submitted on the regulatory requirements for opening an IND application.
In response, ILH says the FDA provided “valuable, multidisciplinary feedback on the proposed clinical development of IHL-675A”.
Importantly for Incannex, the regulating body confirmed that no further nonclinical studies were needed for IHL’s IND application and provided specific guidance on requirements for a New Drug Application (NDA) via the 505(b)(2) pathway.
This would allow IHL to source data for marketing approval from published studies on the components of IHL-675A and/or the FDA’s findings on safety and/or effectiveness for relevant listed drugs.
IHL says it is incorporating this critical guidance into clinical trial design and the overarching development strategy for IHL-675A.