Incannex Healthcare Secures FDA Fast Track Designation For IHL-42X in Obstructive Sleep Apnea

Incannex Healthcare Inc. (NASDAQ:IXHL), a clinical-stage biopharmaceutical company developing innovative combination therapies, announces that the U.S. Food and Drug Administration (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.