Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL) has completed a highly constructive Pre-Investigational New Drug (IND Application meeting with the US Food and Drug Administration (FDA) to discuss the development of IHL-42X.
IHL-42X is a fixed-dose combination of dronabinol and acetazolamide that is being developed as a treatment for obstructive sleep apnoea (OSA) in adults.
Incannex, a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, submitted a pre-IND meeting package and meeting request to the FDA in February 2022.
This package included an overview of the development program and specific questions Incannex had on the regulatory requirements for opening an IND application.
IND required for US trials
Opening an IND is required to conduct clinical trials in the USA and ensures that trials are designed so that they meet the data requirements necessary for FDA marketing approval.
The written responses, and the responses provided in a teleconference with FDA representatives, were constructive and supportive, with interest in the project underpinned by the significant cohort of people diagnosed with OSA and the absence of pharmacological treatment solutions.
Positive feedback
Incannex chief scientific officer Dr Mark Bleackley said 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.”
FDA provided guidance on Incannex’s proposed long-term development strategy, including specific parameters to demonstrate safety and efficacy in phase 2 and 3 pivotal studies.
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 (NDA).
No need for animal studies
In a decision that will save Incannex time and cost, FDA agreed that Incannex does not need to conduct studies in animals.
In particular, the agency confirmed that animal toxicology and animal pharmacokinetic (PK) studies are not required for opening an IND for IHL-42X.
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.
To shape development program
Bleackley said: "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 while 20% of trial participants experienced a reduction in AHI of greater than 80%.
The complete clinical study report is anticipated to be released next month.