Incannex Healthcare Ltd, a clinical-stage pharmaceutical company developing medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies, has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for IHL-42X for the treatment of obstructive sleep apnea.

The IND dossier compiled by the Incannex team includes comprehensive modules on the safety and efficacy of IHL-42X, a cannabinoid combination product, and its component active pharmaceutical ingredients. It also includes detailed information on the development, manufacturing, quality, and stability of the IHL-42X drug product, as well as the clinical protocol and investigator information for the phase 2/3 IND opening clinical trial.

The modules of the IND are:

  • Module 1 – Administrative information and prescribing information
  • Module 2 – Nonclinical/clinical overviews and summaries
  • Module 3 – Quality data
  • Module 4 – Nonclinical study reports and key literature references
  • Module 5 – Clinical study reports, clinical protocol, and investigator information

Submitting an IND to the FDA is crucial for companies to gain regulatory approval, conduct clinical trials, and engage in scientific dialogue with FDA whilst they progress investigational drugs through the stages of development in the United States. The FDA review process for an IND application involves the evaluation of the scientific, clinical, and safety aspects to ensure that the proposed clinical trial meets regulatory requirements.

The IND application details the clinical trial protocol for the IND opening clinical trial, which is a multi-site phase 2/3 clinical trial investigating IHL-42X for the treatment of obstructive sleep apnea. This pivotal trial will assess IHL-42X at the best performing two doses from the successful phase 2 proof-of-concept clinical trial, in patients with OSA who are intolerant, non-compliant, or naïve to positive airway pressure, over a 52-week treatment period.

Participants will receive one of IHL-42X, dronabinol, acetazolamide, or placebo for the entirety of the trial. All participants will complete daily surveys on their sleep quality and attend monthly clinic visits to assess functional outcomes of sleep, cognitive function, and other measures of safety and efficacy. Every three months, overnight polysomnography will be conducted to determine the effect of treatment on the patients’ apnea hypopnea index along with a range of other sleep parameters. All drug treatments will be compared to placebo.

The two principal investigators of the clinical trial were appointed in June and are experienced research clinicians. 

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