Incannex Healthcare Inc. recently announced the US FDA has granted Fast Track designation for IHL-42X, the Company’s oral fixed-dose combination product candidate for the treatment of obstructive sleep apnea (OSA).

The Fast Track designation was supported by promising safety, efficacy, and pharmacokinetic results from the three clinical trials completed to date within the IHL-42X development program. These include the Company’s successful Phase 2 “RePOSA” study demonstrating statistically significant reductions in Apnea-Hypopnea Index (AHI), with individual reductions of up to 83%, outstanding patient-reported outcomes, and an excellent safety profile.

Fast Track designation is granted by the FDA to drug candidates that treat serious conditions and address unmet medical needs with the aim of making important new therapies available to patients sooner.

Under the Fast Track program, IHL-42X will now benefit from:

• More frequent, structured interactions between Incannex and the FDA to discuss clinical strategy, trial design, and data requirements
• Eligibility for rolling review, enabling the Company to submit completed sections of a future New Drug Application (NDA) ahead of the full submission
• Potential access to Accelerated Approval and Priority Review, should relevant criteria be met

Incannex expects to receive detailed written feedback from the FDA in response to its Phase 2 data package and clinical development strategy. The Company expects to provide further updates regarding the FDA’s guidance, the agreed next steps, and the proposed path toward late-stage development once it has received and reviewed this feedback.

“We are delighted with the FDA’s decision to grant Fast Track designation to IHL-42X for OSA. This supports the potential for IHL-42X to address the unmet need for an oral pharmacotherapy for OSA patients. OSA is a serious disease with impacts on both short- and long-term aspects of patient health and quality of life. We look forward to continuing to work with the FDA on the development of IHL-42X,” said Mark Bleackley, Chief Scientific Officer

“We believe Fast Track designation for IHL-42X is one of the most significant regulatory milestones in Incannex’s history. OSA affects millions of people globally, yet there remains no approved oral pharmacotherapy, a gap we are determined to close. Following our exceptional Phase 2 results, this designation validates the strength of our data package and the potential for IHL-42X to transform the treatment landscape. We believe the designation also provides a clear, expedited regulatory pathway, allowing us to accelerate development and capitalise on the pillars we have built throughout the year, including our recent Nasdaq extension. We look forward to working closely with the FDA as we advance IHL-42X toward late-stage development and ultimately to patients who urgently need new options,” added Joel Latham, President & CEO

Incannex is leading the way in developing combination medicines that target the underlying biological pathways associated with chronic conditions, including obstructive sleep apnea, rheumatoid arthritis and generalized anxiety disorder. The company is advancing three clinical-stage product candidates based on evidence-based innovation and supported by streamlined operations. Incannex’s lead clinical program, IHL-42X, is an oral fixed-dose combination of dronabinol and acetazolamide designed to target underlying mechanisms and act synergistically in the treatment of obstructive sleep apnea. In a Phase 2 development program, IHL-675A is an oral fixed-dose combination of cannabidiol and hydroxychloroquine sulfate designed to act synergistically to alleviate inflammatory conditions, such as rheumatoid arthritis. Approved for Phase 2 clinical development, PSX-001 is an oral synthetic psilocybin treatment for the treatment of generalized anxiety disorder. Incannex’s programs target disorders that have limited, inadequate, or no approved pharmaceutical treatment options. For additional information on Incannex, please visit our website at www.incannex.com.