Incannex Healthcare Announces Positive Topline Results from PK Study

Incannex Healthcare Inc. recently released optimistic findings from a pharmacokinetics (PK) study concerning IHL-42X, an oral combination medication intended for managing obstructive sleep apnea. The details of this announcement were disclosed on January 23, 2025. The study results have been made public via a press release appended as Exhibit 99.1 to the company’s recent 8-K filing.

The PK study showcased the bioavailability of IHL-42X, a proprietary compound by Incannex, confirming the delivery of both dronabinol and acetazolamide. The study demonstrated comparable PK and equivalent total drug exposure levels of IHL-42X and the reference listed drugs (RLD) for dronabinol and acetazolamide, thereby establishing a scientific linkage to established safety and toxicology data, potentially supporting a forthcoming FDA 505(b)(2) new drug application (NDA).

Specifically, the results obtained from the PK study on IHL-42X aim to contribute to the evaluation of the anticipated Phase 2/3 data related to assessing IHL-42X in patients diagnosed with obstructive sleep apnea. Notably, the study reported consistently positive safety and tolerability results, with the absence of any serious adverse events.

Incannex Healthcare Inc.’s Chief Scientific Officer, Mark Bleackley, Ph.D., emphasized, “The topline IHL-42X PK findings we are reporting today provide data necessary to support a 505(b)(2) application in accordance with FDA guidance.” These findings align with the company’s expectations and goals for IHL-42X, a unique oral fixed-dose combination therapy.

The recent study adds to the growing potential of IHL-42X and lays the groundwork for future developments. The data not only echoes the outcomes associated with the RLDs but also presents promising avenues for leveraging existing safety information in applying for an FDA 505(b)(2) NDA for IHL-42X.

Given the significance of these findings, Incannex Healthcare Inc. is actively pursuing the analysis of the global Phase 2/3 RePOSA trial, buoyed by the promising results from the PK study. The company’s commitment towards developing innovative combination medicines showcases its dedication to addressing chronic conditions effectively.

The completion of this study marks a significant milestone for Incannex Healthcare Inc., setting a strong foundation for potential advancements in the treatment of obstructive sleep apnea through IHL-42X.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Incannex Healthcare’s 8K filing here.

About Incannex Healthcare

Incannex Healthcare Inc, a clinical stage pharmaceutical development company, engages in the research, development, and sale of medicinal cannabinoid and psychedelic pharmaceutical products and therapies. It develops products for the treatment of obstructive sleep apnoea (OSA), traumatic brain injury (TBI) and concussion, lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis, inflammatory bowel disease, anxiety disorders, addiction disorders, pain, and other indications.