Incannex Healthcare has successfully submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for IHL-42X for treatment of obstructive sleep apnoea.  

Incannex Healthcare (ASX:IHL) said the IND dossier compiled by the IHL team includes comprehensive modules on the safety and efficacy  of  IHL-42X  and  its component active  pharmaceutical ingredients.

The dossier 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 US.

The FDA review process for an IND application involves 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 OSA.

Successful proof of concept trial

The pivotal trial will assess IHL-42X at the best performing two doses following 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.

Trial 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, 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 patient’s Apneoa Hypopnea Index score (AHI) along with a range of other sleep parameters. All drug treatments will be compared to placebo.

Leading experts appointed principal investigators

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

John Douglas Hudson MD is board certified in Neurology and Sleep Medicine and is the principal investigator for FutureSearch Trials of Neurology in Austin.

Hudson has supervised more than 300 clinical trials over the past 20 years mostly related to neurological and sleep disorders and has been a national and international speaker for these disorders.

Dr Russell Rosenberg is currently chief science officer and CEO of NeuroTrials Research in Atlanta.

Rosenberg obtained his doctorate in clinical and research psychology from The Ohio State University and has received specialised training in sleep disorders medicine and research.

He has more than 35 years’ experience in clinical sleep medicine and research, acting as an investigator in more than 300 clinical trials including 14 in OSA and 211 in other sleep related disorders.

No pharmaceutical solution to OSA

OSA is the most common sleep-related breathing disorder and involves narrowing of the upper airway during sleep, interfering with a person’s breathing, decreasing oxygen uptake, resulting in poor-quality sleep.

Untreated OSA leads to serious long-term adverse health outcomes including hypertension, cardiovascular disease, heart attack, cognitive impairments, anxiety and depression, irritability and daytime fatigue increasing the risk of accidents.

There are currently no drug treatments available for OSA, which is surprising given the prevalence of the affliction.

The current treatment standard of care is a Continuous Positive Airway Pressure (CPAP) machine. However, patient compliance to CPAP is quite poor due to various factors related to discomfort.

IHL recently announced it had engaged Fortrea (NASDAQ: FTRE) as the contract research organisation (CRO) for management of the IND opening Phase 2/3 clinical trial.

Fortrea will use its high-value data sets, combined with its technology enabled clinical trial solutions to improve study recruitment, reduce study risk, safeguard data quality, and gain operational insights as the trial progresses

This article was developed in collaboration with Incannex Healthcare, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.