Incannex Healthcare Limited IXHL IHL completed a pre-investigational new drug application ('pre-IND') meeting with the U.S. Food and Drug Administration to discuss the development IHL-42X.
IHL-42X is a fixed dose combination of dronabinol and acetazolamide that is being developed as a treatment for obstructive sleep apnea ('OSA') in adults. Incannex submitted a pre-IND meeting package and meeting request to the FDA in February 2022. The meeting package included an overview of the development program, and specific questions Incannex had on the regulatory requirements for opening an investigational new drug ('IND') application. Opening an IND is required to conduct clinical trials in the U.S and ensures that trials are designed so that they meet the data requirements necessary for FDA marketing approval.
Guidance provided by the FDA to the company will inform adjustments to the clinical trial protocols to ensure that they generate the data required for a 505(b)(2) new drug application.
In a decision that will save Incannex time and cost, FDA agreed that Incannex does not need to conduct studies in animals. Therefore, the next step for the development of IHL-42X will be the adjustment of clinical trial designs and arrangement of operational imperatives necessary to open an IND with FDA.
Chief scientific officer for Incannex, Dr Mark Bleackley, stated: "The FDA's interest in IHL-42X as a potential therapy for OSA was extremely encouraging. The feedback they provided on the overall proposed development program was positive. 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. The results from the pre-IND meeting will shape the IHL-42X development program over the coming months."
Incannex completed a phase 2 proof of concept clinical trial in 2021 to assess IHL-42X in patients with OSA. Preliminary results from the trial have been published, showing that 60% of trial participants experienced a reduction in apnea-hypopnea index ('AHI') of greater than 55% during at least one treatment compared to baseline. 20% of trial participants experienced a reduction in AHI of greater than 80%. The complete clinical study report is anticipated to be released in June 2022.
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