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- Incannex Healthcare (IHL) has met with the FDA to discuss its Pre-Investigational New Drug Application (pre-IND) for the development of IHL-42X
- The drug is being developed to treat obstructive sleep apnoea (OSA) in adults
- Incannex says representatives from the FDA showed interest in the drug due to the significant number of people diagnosed with OSA and the lack of treatment options
- The drug regulator provided guidance on the company’s long-term development strategy, with Incannex now adjusting clinical trial designs
- Incannex shares last traded at 45.5 cents each on Monday, May 16
Incannex Healthcare (IHL) has been given fresh guidance from the US Food and Drug Administration (FDA) regarding its Pre-Investigational New Drug Application (pre-IND) for its IHL-42X product.
The drug is being developed to treat obstructive sleep apnoea (OSA) in adults.
Incannex said representatives from the FDA showed interest in the drug due to the significant number of people diagnosed with OSA and the lack of treatment options.
The drug regulator has now provided guidance on Incannex’s long-term development strategy, outlining specific parameters to demonstrate safety and efficacy in the phase two and three pivotal studies.
Meanwhile, Incannex said the FDA agreed the company did not need to conduct studies in animals — a decision that will save Incannex time and money as it develops IHL-42X.
Incannex will now adjust its clinical trial designs and complete the operational imperatives necessary to open an IND with the FDA.
“The agency’s responses to the specific questions we posed allow us to revise our clinical trial protocols to ensure that we are running highly efficient studies that generate the type and amount of data the FDA will require in a future marketing application,” Chief Scientific Officer Dr Mark Bleackley said.
“The results from the pre-IND meeting will shape the IHL-42X development program over the coming months.”
Incannex shares last traded at 45.5 cents each on Monday, May 16.
