Incannex Healthcare Ltd (ASX:IHL, NASDAQ: IXHL) chief scientific officer Dr Mark Bleackley tells Proactive the company 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 US and ensures trials are designed to meet data requirements for future FDA approvals.
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,” 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.”
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