Incannex Receives IRB Approval for the RePOSA Phase 2/3 Clinical Trial Protocol to Assess IHL-42X Drug in Patients with Obstructive Sleep Apnea

Rhea-AI Summary

Incannex Healthcare Inc. (Nasdaq: IXHL) has received IRB approval for the protocol of its Phase 2/3 clinical trial for the drug candidate IHL-42X to treat obstructive sleep apnea (OSA). The trial will assess safety and efficacy in OSA patients who are intolerant, non-compliant, or naïve to positive airway pressure (PAP). The study aims to recruit at least 560 patients across the United States, Germany, Spain, and Finland. The Phase 2/3 trial has already begun startup with 24 sites selected in the United States, 13 in Germany, 4 in Spain, and 2 in Finland. IHL-42X has shown promising results in a Phase 2 proof-of-concept study, reducing the apnea hypopnea index (AHI) by over 50% at the optimal dose, improving oxygen desaturation index, sleep efficiency, and patient-reported sleep quality.

Positive

• IRB approval obtained for the Phase 2/3 clinical trial protocol
• Study aims to recruit at least 560 patients across multiple countries
• Promising results in Phase 2 proof-of-concept study for IHL-42X

Negative

• None.

Pharmaceutical Industry Analyst

The approval of the Phase 2/3 clinical trial protocol for IHL-42X by an independent Institutional Review Board (IRB) represents a significant milestone for Incannex Healthcare Inc. in the development of treatments for obstructive sleep apnea (OSA). This event is pivotal because it validates the trial's design and ethical standards, enabling the commencement of research at U.S. sites. The progression from a proof-of-concept study to a larger-scale trial underscores the therapeutic potential of IHL-42X, which has shown promising results in reducing the apnea hypopnea index (AHI) by over 50% at optimal doses. The combination of dronabinol and acetazolamide in IHL-42X could offer a novel pharmacological approach to OSA, addressing a significant unmet need for patients intolerant to standard positive airway pressure therapies.

From an industry perspective, the seamless transition design between Phase 2 and Phase 3 trials could set a precedent for accelerating development timelines, a strategy that other pharmaceutical companies may emulate. The size of the trial, with at least 560 patients and the multinational spread of trial sites, reflect the company's commitment to robust data collection and the potential for market expansion. The efficacy endpoints and patient-reported outcomes, such as sleep quality improvements, are critical for regulatory approval and market adoption, as they align with the FDA's emphasis on patient-centric measures.

Medical Research Analyst

The IRB's approval of Incannex Healthcare's IHL-42X for OSA trials is a testament to the drug's safety profile and the ethical considerations of the study. The focus on a patient population that is intolerant, non-compliant, or naïve to positive airway pressure (PAP) therapies is strategic, targeting a subset of OSA sufferers who are currently underserved by the market. The dual-component design of the RePOSA study, with a dose-ranging Phase 2 trial and a comparative Phase 3 trial, is scientifically sound, allowing for the determination of both the optimal dose and comparative efficacy against individual active pharmaceutical ingredients (APIs) and placebo.

The reported improvements in oxygen desaturation index and sleep efficiency are particularly noteworthy, as these are key indicators of OSA severity and patient quality of life. If IHL-42X continues to demonstrate a favorable safety and efficacy profile, it could become a significant advancement in sleep medicine. However, it is essential to remain cautious until data from the larger, more diverse Phase 2/3 cohort confirms these findings.

Healthcare Economist

The economic implications of a successful IHL-42X drug for OSA are considerable. OSA is a prevalent condition with substantial direct and indirect costs to the healthcare system, including increased risk of cardiovascular disease, workplace accidents and reduced productivity. Current treatments like continuous positive airway pressure (CPAP) machines have compliance issues, leading to ongoing unmanaged health risks and associated costs. A new pharmacotherapy like IHL-42X could reduce these burdens by providing an alternative for those who struggle with CPAP devices.

Moreover, the potential reduction in OSA symptoms could translate into decreased healthcare utilization and improved work performance, contributing to broader economic benefits. The cost-effectiveness of IHL-42X will be a key factor in its adoption, with pricing strategies needing to balance affordability and the company's return on investment. If the trial outcomes are positive, Incannex Healthcare could capture a significant share of the OSA treatment market, which would have a notable impact on its financial performance and attractiveness to investors.

MELBOURNE, Australia and NEW YORK, Jan. 17, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex’ or the ‘Company’), a pharmaceutical company developing unique medicinal cannabinoid pharmacotherapies and psychedelic medicine therapies is pleased to announce that an independent Institutional Review Board (IRB) has approved the protocol for the Company’s Phase 2/3 clinical trial to be conducted in the United States to assess safety and efficacy of proprietary combination drug candidate IHL-42X in patients with obstructive sleep apnea (OSA). IRB approval of the protocol is a key step in activation of clinical trial sites for the RePOSA study.

Under regulations of the Food & Drug Administration, IRB approval is required prior to commencing research in human subjects and serves to ensure that appropriate measures are in place to protect the rights and welfare of research participants. The approval process involves review of the research protocol, informed consent procedures, recruitment materials, and participant risk versus benefit analysis.

The RePOSA Clinical Trial

The RePOSA study is a Phase 2/3, randomised, double-blind clinical trial to determine the safety and efficacy of IHL-42X in subjects with OSA who are intolerant, non-compliant, or naïve to positive airway pressure (PAP), such as that administered via a continuous positive airway pressure (CPAP) machine.

The RePOSA study consists of two component studies. A four-week Phase 2 dose ranging trial that will determine the optimal dose of IHL-42X based on safety and efficacy in OSA patients, and a 52-week Phase 3 factorial trial that will compare the optimal dose of IHL-42X to the component APIs, dronabinol and acetazolamide, at equivalent doses, as well as placebo. The study is designed to facilitate a seamless transition between Phase 2 and Phase 3, reducing downtime and accelerating development timelines.

The endpoints, inclusion criteria and study procedures are the same across both component studies, which streamlines the transition process from Phase 2 to Phase 3. The target patient population is individuals aged 18 years or older with OSA who are intolerant, non-compliant or naïve to Positive Airway Pressure. At least 560 patients will be recruited, with a total of 355 patients receiving IHL-42X over the course of the study. RePOSA is registered on clinicaltrials.gov with identification code NCT06146101.

Start-up for the Phase 2/3 trial is in progress with 24 sites selected in the United States, 13 in Germany, 4 in Spain and 2 in Finland. IRB approval of the protocol allows the U.S.-based sites to proceed with site-specific approval, which is a critical step in site activation.

The RePOSA study follows a Phase 2 proof-of-concept study whereby IHL-42X reduced apnea hypopnea index (AHI), the main measure used to diagnose and monitor OSA, by greater than 50% at the optimal dose, which was the low dose in the study. At the low dose of IHL-42X patient changes in AHI relative to baseline revealed that, during the treatment period, 62.5% of patients experienced a reduction in AHI of greater than 50% and 25 % of patients experienced a reduction in AHI of greater than 80%. IHL-42X also improved participant oxygen desaturation index, sleep efficiency, and patient reported sleep quality. IHL-42X was well tolerated in the study.

About Obstructive Sleep Apnea (OSA)

OSA is the most common sleep-related breathing disorder. It involves the narrowing of the upper airway during sleep, interfering with a person’s breathing, decreasing oxygen uptake, resulting in poor-quality sleep¹. 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 no pharmacotherapy (drug) treatments available to those afflicted.

The current ‘standard of care’ is the Positive Airway Pressure (PAP) machine. However, patient compliance to PAP is low due to various factors related to patient discomfort. Incannex anticipates greatly improved treatment compliance and outcomes from a pharmaceutical product, such as IHL-42X, subject to further clinical assessment and approval from regulators.

Regardless of the discomfort caused by PAP, the global annual market for OSA detection and treatment using PAP and other breathing aides is approximately US$10 billion per annum and growing². OSA is highly prevalent, affecting approximately 30 million adults in the United States alone. It is estimated that the annual economic burden of undiagnosed sleep apnoea among U.S. adults is approximately US$149.6 billion per annum. These costs include US$86.9 billion in lost productivity, US$26.2 billion in motor vehicle accidents and US$6.5 billion in workplace accidents³.

References

¹https://www.mayoclinic.org/diseases-conditions/obstructive-sleep-apnea/symptoms-causes/syc-20352090
²https://www.fortunebusinessinsights.com/industry-reports/sleep-apnea-devices-market-100708
³https://aasm.org/resources/pdf/sleep-apnea-economic-crisis.pdf

About Incannex Healthcare Inc.

Incannex is a clinical stage pharmaceutical development company that is developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies 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, and pain, among other indications.

U.S. FDA approval and registration, subject to ongoing clinical success, is being pursued for each drug and therapy under development. Each indication under investigation currently has no, or limited, existing registered pharmacotherapy (drug) treatments available to the public and represent major global economic opportunities to Incannex and its shareholders.

Incannex has a strong patent filing strategy in place as it develops its products and therapies in conjunction with its medical and scientific advisory board and partners. The Company holds 20 granted patents and over 30 pending patent applications.

Website: www.incannex.com
Investors: investors@incannex.com.au  

Forward-looking statements
This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are made as of the date they were first issued and were based on current expectations and estimates, as well as the beliefs and assumptions of management. The forward-looking statements included in this press release represent Incannex's views as of the date of this press release. Incannex anticipates that subsequent events and developments may cause its views to change. Incannex undertakes no intention or obligation to update or revise any forward-looking statements, whether as of a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Incannex's views as of any date after the date of this press release.

Contact Information:

Incannex Healthcare Inc.
Mr Joel Latham
Chief Executive Officer, President and Director
admin@incannex.com.au

Investor Relations Contact – United States
Jennifer Drew-Bear
Edison Group
+1 (860) 573 9637
jdrew-bear@edisongroup.com

FAQ

What is the purpose of the Phase 2/3 clinical trial for IHL-42X?

The trial aims to assess the safety and efficacy of IHL-42X in patients with obstructive sleep apnea (OSA) who are intolerant, non-compliant, or naïve to positive airway pressure (PAP).

How many patients are expected to be recruited for the trial?

At least 560 patients will be recruited across the United States, Germany, Spain, and Finland.

Where will the Phase 2/3 trial take place?

The trial will have 24 sites in the United States, 13 in Germany, 4 in Spain, and 2 in Finland.

What were the results of the Phase 2 proof-of-concept study for IHL-42X?

IHL-42X reduced the apnea hypopnea index (AHI) by over 50% at the optimal dose, improved oxygen desaturation index, sleep efficiency, and patient-reported sleep quality.

What is the identification code for the RePOSA study on clinicaltrials.gov?

The study is registered with identification code NCT06146101 on clinicaltrials.gov.