Incannex Healthcare (ASX: IHL), a clinical-stage pharmaceutical company, has taken a significant step towards enhancing the comfort of sleep apnoea sufferers and disrupting the multi-billion dollar medical equipment industry. The company is preparing for the next stage of testing its cannabinoid pharmaceutical product, IHL-42X, which aims to reduce the reliance on expensive and uncomfortable medical equipment currently used for sleep apnoea treatment. Obstructive sleep apnoea (OSA) occurs when a person experiences breathing pauses at night due to partial or complete blockage of the throat during sleep.
Growing Market and Potential Disruption
The global sleep apnoea devices market is estimated to be worth US$5.8 billion (A$8.4 billion) in 2023, with projections indicating it could reach US$8.0 billion (A$11.6 billion) by 2028. Incannex aims to disrupt this market by providing a novel, user-friendly treatment in pill form. The company has already shown promising results in early trials with IHL-42X.
Key Appointments for Investigational New Drug Application
In preparation for the next phase of clinical trials, Incannex has appointed two highly regarded lead principal investigators (PIs). Dr. John Hudson of FutureSearch Trials of Neurology from Austin, Texas, and Dr. Russell Rosenberg of Neurotrials Research of Atlanta, Georgia, are renowned experts in the field of neurological and sleep disorders. Dr. Hudson has supervised over 300 clinical trials related to these disorders, while Dr. Rosenberg has more than 35 years of experience in clinical sleep medicine and research.
Significance of Principal Investigators
The recruitment of Dr. Hudson and Dr. Rosenberg as lead principal investigators is a critical step for Incannex’s Investigational New Drug Application (IND) opening Phase 2/3 clinical trial. As experts in their respective fields, their endorsement demonstrates confidence in the efficacy of IHL-42X, as shown in the phase 2 proof of concept studies. Their associated facilities will serve as the first clinical trial sites for submission to the US Food and Drug Administration (FDA) and for ethics approval from Institutional Review Boards.
Addressing Unmet Needs in Sleep Apnoea Treatment
Millions of people worldwide are affected by obstructive sleep apnoea, which remains under-treated due to various factors, including poor patient compliance with current therapeutic modalities. Dr. Hudson highlights that the investigation of oral medications to reduce the underlying cause of OSA is an exciting development that could be life-changing for many patients. Dr. Rosenberg emphasizes the importance of providing an alternative therapy for patients who struggle with positive airway pressure therapy, the current standard treatment.
Promising Results from Phase 2 Proof of Concept Trials
Incannex conducted phase 2 proof of concept clinical trials for IHL-42X, involving 44 participants. The trial demonstrated a significant reduction in the apnoea-hypopnea index (AHI) compared to the placebo group. Participants in the IHL-42X arm experienced a 50.7% reduction in AHI, with 60% experiencing a greater than 55% reduction and 25% achieving an 80% or greater reduction. IHL-42X is a proprietary synergistic composition drug containing low-dose dronabinol and acetazolamide.
In conclusion, Incannex’s appointment of key investigators for its sleep apnoea trial marks a significant milestone in the development of its cannabinoid pharmaceutical product. With the potential o disrupt the sleep apnoea treatment market, IHL-42X offers a user-friendly alternative to existing medical equipment. The positive results from phase 2 proof of concept trials provide a strong foundation for advancing to the next stage of clinical testing. By collaborating with esteemed experts in the field, Incannex aims to provide a safe and effective pharmacological option for patients with obstructive sleep apnoea, addressing the unmet needs in this field of medical treatment.
