Incannex Healthcare (ASX: IHL) has completed a pre-investigational new drug (pre-IND) application meeting with the US Food and Drug Administration (FDA) relating to its proprietary drug product IHL-675A for the treatment of rheumatoid arthritis.
The company submitted a meeting package in June which included a description of IHL-675A’s unique formulation, an overview of the proposed clinical development plan and specific questions on the regulatory requirements for opening an investigational new drug (IND) application.
The opening of an IND is required to conduct trials in the US and ensures that trials meet the data requirements needed for FDA marketing approval.
Valuable feedback
Incannex said the FDA provided “valuable, multidisciplinary feedback” on the proposed clinical development of IHL-675A which will be incorporated into clinical trial designs and the overall development strategy.
Importantly, the FDA confirmed that no further non-clinical studies would be needed for the IND application.
It also outlined the requirements for a new drug application via the 505(b)(2) pathway, where information required for marketing approval is derived from published studies on the components of IHL-675A as well as FDA findings on the safety and effectiveness of relevant listed drugs.
As well as expected
Incannex chief scientific officer Dr Mark Bleackley said the pre-IND meeting went as well as expected.
“The FDA’s responses covered multiple aspects of our development strategy and will be incorporated into our clinical trial designs and research plans… the feedback is highly valuable for the continued development of IHL-675A,” he said.
“We look forward to continuing to work with the FDA to ensure our development program generates high quality data which addresses the agency’s requirements.”
Combination product
IHL-675A is a proprietary combination product containing cannabidiol (CBD) and off-patent registered pharmaceutical prescribable drug hydroxychloroquine sulfate (HCQ) for the treatment of inflammatory disorders including rheumatoid arthritis.
HCQ is a disease-modifying anti-rheumatic drug which can regulate the activity of the immune system in some conditions where it becomes overactive.
It is reported to be capable of altering the underlying disease process, rather than simply treating the symptoms.
Incannex has demonstrated that IHL-675A which is CBD and HCQ combined can act synergistically to inhibit production of key inflammatory cytokines in an in vitro study of human cells and in four distinct in vivo experiments using established models of inflammation.
The reduction in disease assessments achieved by IHL-675A in animal studies was substantially more than that observed for HCQ alone at the standard dose.
These promising observations led the company to prioritise rapid clinical assessment, particularly given that HCQ, marketed as Plaquenil and generic equivalents, is a common long-standing treatment prescribed for rheumatoid arthritis with a considerable market profile.
