Patient dosing commenced in RePOSA Phase 2/3 Clinical Trial Protocol to Assess IHL-42X Drug in Patients with Obstructive Sleep Apnea
Incannex Healthcare has commenced patient dosing in its Phase 2/3 RePOSA clinical trial to assess the safety and efficacy of IHL-42X in treating obstructive sleep apnea (OSA). This trial is significant as it follows a successful Phase 2A study that showed a greater than 50% reduction in the apnea hypopnea index (AHI) at low doses, with 25% of patients achieving over 80% reduction. The trial will span 52 weeks, involving 560 patients across the US, EU, and UK, and aims to provide an alternative to CPAP machines which many patients find intolerable. If successful, IHL-42X could address a large unmet medical need and create substantial commercial and shareholder value.
- Commencement of patient dosing in the Phase 2/3 clinical trial marks a significant milestone for Incannex.
- The trial follows a promising Phase 2A study showing a >50% reduction in AHI at low doses and >80% reduction in 25% of patients.
- The RePOSA study involves 560 patients, enhancing the robustness of the trial.
- Phase 2 and Phase 3 studies are designed to facilitate a seamless transition, expediting time to commercial product development.
- IHL-42X could address a significant unmet need for OSA patients who are intolerant or non-compliant with PAP devices.
- The potential market for IHL-42X is immense, with no currently registered pharmacotherapies for OSA.
- Successful development could unlock tremendous commercial value and enhance shareholder value.
- The success of IHL-42X is not guaranteed and hinges on the outcomes of the ongoing clinical trial.
- The trial will span 52 weeks, potentially delaying the time to market if any issues arise during the study.
- The study involves a substantial amount of patients, which could lead to higher operational costs.
- Extending Phase 3 to additional sites across the EU and UK adds logistical complexity and potential delays.
Insights
The commencement of patient dosing in the Phase 2/3 clinical trial for IHL-42X by Incannex is a noteworthy advancement. This combination drug aims to address obstructive sleep apnea (OSA), a condition with limited pharmacological treatment options. The trial’s design, which includes a seamless transition between Phase 2 and Phase 3, is intended to expedite the drug's development, reflecting a strategic approach to bring IHL-42X to market efficiently.
Patient outcomes in the Phase 2A study were promising, with significant reductions in the apnea hypopnea index (AHI) – the standard metric for OSA. If these results are replicated in the larger Phase 2/3 trial, IHL-42X could fulfill a substantial unmet need, potentially improving compliance compared to current positive airway pressure devices.
The drug’s mechanism involves the synergistic effects of dronabinol and acetazolamide. Dronabinol, a cannabinoid, has properties that may reduce airway resistance, while acetazolamide is a carbonic anhydrase inhibitor that can help decrease sleep disturbances. This dual approach makes IHL-42X a novel intervention in the OSA treatment landscape.
For investors, this trial phase represents a critical period. With no registered pharmacotherapies for OSA, the success of IHL-42X could open a vast market, enhancing both patient outcomes and shareholder value. However, the trial's long duration and potential regulatory hurdles should be considered in any investment analysis.
Incannex’s announcement marks a pivotal milestone for the company. The transition from Phase 2A results to a comprehensive Phase 2/3 clinical trial indicates significant progress. From a financial perspective, this could signal increased investor confidence and potential upward movement in stock value due to the drug's large market potential.
Obstructive sleep apnea (OSA) affects millions globally and the absence of effective oral pharmacotherapies presents a lucrative market opportunity. The potential for IHL-42X to capture a portion of this market could lead to substantial revenue growth for Incannex if the trial succeeds and the drug gains FDA approval.
Additionally, the strategic trial design, which minimizes downtime between phases, could expedite the drug’s market entry, a positive for revenue projections. Investors should monitor key milestones such as interim results from the trial and updates on patient recruitment. Any delays or adverse findings could impact stock performance.
However, it’s important to remain cautious. Clinical trials are inherently risky and the success of Phase 2A does not guarantee Phase 3 results. Financial projections should account for potential setbacks and the lengthy approval process.
NEW YORK and MELBOURNE, Australia, May 30, 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 patient dosing has commenced in the Company’s Phase 2/3 clinical trial to assess safety and efficacy of IHL-42X in patients with obstructive sleep apnea (‘OSA’).
IHL-42X is the Company’s proprietary fixed dose combination drug for treatment of obstructive sleep apnea. Commencement of patient dosing in the United States represents a significant milestone in its development. Initiating dosing in the trial follows the opening of an Investigational New Drug (IND) application with the FDA and a Phase 2A study completed in 2022 whereby Incannex observed IHL-42X to reduce the apnea hypopnea index (AHI), the standard measure of OSA, by an average of greater than
Dr Mark Bleackley, Incannex Chief Scientific Officer said, “Patient dosing in the RePOSA study represents a critical step forward in the development of IHL-42X for treatment of obstructive sleep apnea. There are currently no registered pharmacotherapies available to patients and poor compliance to positive air way pressure devices means that many patients with sleep apnea are left untreated or chronically under-treated. IHL-42X has the potential to address this unmet need, improving the direct effects of sleep apnea, as well as the associated long-term health, and quality of life, impacts on this patient population. We look forward to working with trial sites and investigators to continue to recruit and dose patients in the RePOSA trial”
Joel Latham, Incannex CEO and President said, "We are thrilled to announce this significant milestone for our company, being first patient dosing in a major clinical trial assessing our IHL-42X candidate. This achievement marks a pivotal step forward in addressing a significant unmet medical need, as there are no orally administered pharmaceutical products registered with FDA for patients with sleep apnea. Therefore, the potential market for IHL-42X is immense, and its success could revolutionize the treatment landscape for this serious medical condition. We believe that, if successful, our drug will not only unlock tremendous commercial value but also significantly enhance shareholder value”.
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 trial is designed to facilitate a seamless transition between Phase 2 and Phase 3, intended to reduce downtime, accelerating time to commercial product development.
The endpoints, inclusion criteria and study procedures are the same across both component studies, streamlining the transition 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. Phase 2 of the RePOSA study will be conducted at 25 sites in the United States. Phase 3 will extend the study to 30 additional sites across the EU and UK.
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
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. Incannex is listed and publicly traded on Nasdaq (NAS: IXHL), providing investors an opportunity to participate in the Company's growth.
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
Jdrew-bear@edisongroup.com
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