Incannex Healthcare Completes Phase 2 Enrollment in RePOSA Phase 2/3 Trial of IHL-42X, an Oral Once-Daily Treatment for Obstructive Sleep Apnea (OSA)
Incannex Healthcare (Nasdaq: IXHL) has completed Phase 2 patient enrollment in its global Phase 2/3 RePOSA study of IHL-42X, an oral treatment for Obstructive Sleep Apnea (OSA). The study enrolled over 120 patients across 11 U.S. sites, with topline Phase 2 data expected in first half 2025.
The Phase 2 trial is comparing two dose strengths of IHL-42X to placebo over four weeks. The subsequent Phase 3 expansion will evaluate the selected dose over 52 weeks across 440 patients, comparing it to individual components and placebo.
IHL-42X is designed as a once-daily oral fixed dose combination medicine targeting the underlying causes of OSA. The RePOSA study focuses on patients with mild to severe OSA who are intolerant, non-compliant, or naïve to positive airway pressure therapy. The trial aims to support future regulatory submission through the FDA 505(b)(2) pathway.
Incannex Healthcare (Nasdaq: IXHL) ha completato l'arruolamento dei pazienti nella Fase 2 del suo studio globale RePOSA di Fase 2/3 per IHL-42X, un trattamento orale per l'apnea ostruttiva del sonno (OSA). Lo studio ha arruolato oltre 120 pazienti in 11 siti negli Stati Uniti, con dati preliminari della Fase 2 attesi nella prima metà del 2025.
Il trial di Fase 2 confronta due dosi di IHL-42X con un placebo per un periodo di quattro settimane. La successiva espansione della Fase 3 valuterà la dose selezionata per 52 settimane su 440 pazienti, confrontandola con i singoli componenti e il placebo.
IHL-42X è progettato come un medicinale combinato a dose fissa da assumere una volta al giorno, mirato a trattare le cause sottostanti dell'OSA. Lo studio RePOSA si concentra su pazienti con OSA da lieve a grave che sono intolleranti, non compliant o naïve alla terapia con pressione positiva delle vie aeree. Il trial mira a supportare una futura presentazione normativa attraverso il percorso FDA 505(b)(2).
Incannex Healthcare (Nasdaq: IXHL) ha completado la inscripción de pacientes en la Fase 2 de su estudio global RePOSA de Fase 2/3 para IHL-42X, un tratamiento oral para la apnea obstructiva del sueño (OSA). El estudio inscribió a más de 120 pacientes en 11 sitios de EE. UU., con datos preliminares de la Fase 2 esperados en la primera mitad de 2025.
El ensayo de Fase 2 compara dos dosis de IHL-42X con un placebo durante cuatro semanas. La expansión subsiguiente de la Fase 3 evaluará la dosis seleccionada durante 52 semanas en 440 pacientes, comparándola con los componentes individuales y el placebo.
IHL-42X está diseñado como un medicamento combinado de dosis fija que se toma una vez al día, dirigido a las causas subyacentes de la OSA. El estudio RePOSA se centra en pacientes con OSA de leve a grave que son intolerantes, no cumplen o son naïve a la terapia de presión positiva en las vías respiratorias. El ensayo tiene como objetivo apoyar la futura presentación regulatoria a través de la vía FDA 505(b)(2).
Incannex Healthcare (Nasdaq: IXHL)는 OSA(폐쇄성 수면 무호흡증)에 대한 경구 치료제 IHL-42X의 글로벌 2/3상 RePOSA 연구에서 2상 환자 등록을 완료했습니다. 이 연구는 미국 내 11개 사이트에서 120명 이상의 환자를 등록하였으며, 2상 주요 데이터는 2025년 상반기에 예상됩니다.
2상 시험은 4주 동안 IHL-42X의 두 가지 용량을 플라시보와 비교하고 있습니다. 이후 3상 확장에서는 440명의 환자를 대상으로 선택된 용량을 52주 동안 평가하고, 개별 성분 및 플라시보와 비교할 것입니다.
IHL-42X는 OSA의 근본 원인을 목표로 하는 하루 한 번 복용하는 고정 용량 복합 약물로 설계되었습니다. RePOSA 연구는 OSA가 경증에서 중증인 환자 중에서 양압 치료에 내성이 있거나 비순응적이거나 처음인 환자에 초점을 맞추고 있습니다. 이 시험은 FDA 505(b)(2) 경로를 통해 향후 규제 제출을 지원하는 것을 목표로 하고 있습니다.
Incannex Healthcare (Nasdaq: IXHL) a terminé l'inscription des patients à la phase 2 de son étude mondiale RePOSA de phase 2/3 sur l'IHL-42X, un traitement oral pour l'apnée obstructive du sommeil (OSA). L'étude a inscrit plus de 120 patients dans 11 sites aux États-Unis, avec des données préliminaires de la phase 2 attendues au premier semestre 2025.
Le procès de phase 2 compare deux dosages d'IHL-42X à un placebo sur une période de quatre semaines. L'expansion subséquente de la phase 3 évaluera la dose sélectionnée sur 52 semaines auprès de 440 patients, en la comparant aux composants individuels et au placebo.
L'IHL-42X est conçu comme un médicament combiné à dose fixe à prendre une fois par jour, visant à traiter les causes sous-jacentes de l'OSA. L'étude RePOSA se concentre sur les patients souffrant d'OSA légère à sévère qui sont intolérants, non conformes ou naïfs vis-à-vis de la thérapie par pression positive des voies respiratoires. L'essai vise à soutenir une future soumission réglementaire via le chemin FDA 505(b)(2).
Incannex Healthcare (Nasdaq: IXHL) hat die Patientenrekrutierung für die Phase 2 seiner globalen Phase 2/3 RePOSA-Studie zu IHL-42X, einer oralen Behandlung für obstruktive Schlafapnoe (OSA), abgeschlossen. Die Studie rekrutierte über 120 Patienten an 11 Standorten in den USA, mit den vorläufigen Daten der Phase 2, die in der ersten Hälfte von 2025 erwartet werden.
Die Phase-2-Studie vergleicht zwei Dosierungen von IHL-42X mit einem Placebo über einen Zeitraum von vier Wochen. Die anschließende Phase-3-Erweiterung wird die ausgewählte Dosis über 52 Wochen an 440 Patienten bewerten und mit den einzelnen Komponenten und dem Placebo vergleichen.
IHL-42X ist als einmal täglich einzunehmendes, kombiniertes Medikament mit fester Dosis konzipiert, das auf die zugrunde liegenden Ursachen von OSA abzielt. Die RePOSA-Studie konzentriert sich auf Patienten mit leichter bis schwerer OSA, die intolerant, nicht compliant oder naïv gegenüber der positiven Atemwegsdrucktherapie sind. Die Studie zielt darauf ab, die zukünftige regulatorische Einreichung über den FDA 505(b)(2)-Weg zu unterstützen.
- Completed Phase 2 enrollment ahead of typical recruitment timelines
- Strong patient interest indicates high market demand
- First-in-class therapy targeting underlying OSA mechanisms
- No currently approved pharmaceutical therapy for OSA, representing significant market opportunity
- Phase 2 results not expected until first half 2025
- Long development timeline with 52-week Phase 3 study still ahead
- Will need to demonstrate superiority over individual components in Phase 3
Insights
Incannex's completion of Phase 2 enrollment represents a meaningful advancement in their clinical development program for IHL-42X, targeting the obstructive sleep apnea (OSA) market - a condition with no approved pharmaceutical therapies currently available.
The enrollment of over 120 patients across 11 U.S. sites completing faster than typical recruitment timelines signals strong interest from both patients and investigators. This efficiency suggests both operational execution by management and genuine market demand for alternative OSA treatments beyond existing device-based approaches like PAP therapy.
From a development perspective, the trial design is particularly notable. The seamless Phase 2/3 approach, where Phase 2 serves as a dose-finding study for the larger Phase 3, represents an efficient regulatory strategy. This design can accelerate development timelines by avoiding delays between separate trials while still generating the necessary data for eventual regulatory submission.
The dual-component approach (dronabinol/acetazolamide) targeting physiological pathways related to airway obstruction and CO2 accumulation represents a novel mechanistic approach. If successful, this could potentially address underlying disease mechanisms rather than just symptom management.
While milestone achievement is positive, prudent investors should recognize that enrollment completion merely enables the next crucial phase - generating actual efficacy data in the first half of 2025. The true value inflection remains dependent on these forthcoming results.
Topline Phase 2 clinical data expected in the first half 2025
NEW YORK and MELBOURNE, Australia, April 03, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex), a clinical-stage biopharmaceutical company leading the way in developing new oral combination medicines, today announced that the Company has completed Phase 2 patient enrollment in the global Phase 2/3 RePOSA study of IHL-42X for the treatment of Obstructive Sleep Apnea (OSA). IHL-42X is an oral fixed dose combination medicine designed to reduce the incidence of interruptions to breathing during sleep and improve sleep quality.
“We are excited to have achieved this milestone and deeply grateful to our investigators, site coordinators, and, especially to the sleep apnea patient community for its support. The pace at which we fully enrolled the Phase 2 portion of the RePOSA Phase 2/3 study strengthens our confidence in this program. OSA is a serious, chronic, and life-threatening condition, and we believe our once-daily oral medication - designed to target underlying causes of OSA - could offer meaningful benefits to patients,” Lou Barbato, M.D., Chief Medical Officer of Incannex.
“What makes IHL-42X truly unique is that it’s the first new therapeutic in its class to target physiological pathways directly tied to the airway obstruction and CO2 accumulation, both of which are characteristic of OSA. We are eager to report topline clinical data from Phase 2 portion of the study and progress to the larger Phase 3 as swiftly as possible,” said Mark Bleackley, Ph.D., Chief Scientific Officer of Incannex.
“We are pleased to have completed Phase 2 recruitment in the IHL-42X RePOSA clinical trial. The speed at which patients enrolled in the study was impressive, surpassing typical recruitment timelines for trials of this nature. This strong interest underscores the pressing need for more effective pharmaceutical options to manage OSA,” said Mira Baron, M.D., a lead investigator for the RePOSA Phase 2/3 trial, Palm Beach Research Center. “Despite the widespread global prevalence of obstructive sleep apnea, there is still no approved pharmaceutical therapy specifically for the treatment of OSA. The positive response from both clinicians and patients reflects the real-world demand for a well-tolerated and effective therapeutic option. IHL-42X represents an exciting and novel approach for filling this longstanding treatment gap. I look forward to seeing the progress we are making in partnership with Incannex to further advance this program and address a critical need in sleep medicine.”
The RePOSA Phase 2/3 is a randomized, double-blind clinical trial designed to evaluate the safety and efficacy of IHL-42X in patients with mild to severe OSA, who are intolerant, non-compliant, or naïve to positive airway pressure (PAP) therapy. At least 560 patients will be recruited, with a total of 355 patients receiving IHL-42X over the course of the study.
The Phase 2 study is a four-week, dose-finding study comparing two dose strengths of IHL-42X (2.5 mg dronabinol/125 mg acetazolamide and 5 mg dronabinol/250 mg acetazolamide) to placebo. More than 120 patients were enrolled across 11 study sites in the U.S. Phase 2 results will determine the optimal dose strength to advance into the larger Phase 3 trial.
The Phase 3 expansion study will evaluate the selected IHL-42X dose over 52 weeks, comparing it to its individual active pharmaceutical ingredients, dronabinol and acetazolamide, at equivalent doses, and to placebo. This pivotal study will enroll approximately 440 patients across four treatment arms, with the goal of supporting future regulatory submission and providing a potential new treatment option for patients with OSA who are underserved by current therapies. Phase 2 trials sites will be rolled over into the Phase 3 expansion study, allowing for an efficient transition and minimizing downtime between study phases.
The Phase 2/3 study follows a recently completed successful pharmacokinetic (PK) study designed to support a future FDA 505(b)(2) new drug application (NDA) and aid in the analysis of the global Phase 2/3 RePOSA study data, in addition to an earlier Phase 2 clinical proof-of-concept trial. Additional information about the RePOSA study can be found at www.clinicaltrials.gov under trial identifier NCT06146101.
About Obstructive Sleep Apnea (OSA)
Obstructive sleep apnea is a chronic, serious, and life-threatening condition characterized by frequent interruptions in breathing. Individuals with OSA experience apneic episodes, waking up gasping for air 15 to 30 times per hour. During apneic episodes, collapse and obstruction of the upper airway lead to intermittent cessation of breathing, hypoxia (low oxygen levels), and hypercapnia (inadequate expulsion of carbon dioxide). This results in poor quality of sleep, severe and daytime fatigue, insomnia, difficulty concentrating, and irritability. OSA is also linked to serious medical conditions, including high blood pressure, heart disease, Type 2 diabetes, metabolic syndrome, liver disease, and complications with medicines and during surgery.
More than 54 million adults in the U.S. and 936 million worldwide suffer from OSA, with prevalence on the rise due to aging populations, obesity, metabolic syndrome, and sedentary lifestyles. Public awareness is increasing, along with advancements in professional and consumer diagnostic technologies, contributing to earlier diagnosis and treatment. Notably, approximately
Current treatment options for moderate-to-severe OSA, such as continuous positive airway pressure (CPAP) devices and an injectable GIP/GLP-1 agonist for patients with obesity, have significant drawbacks in terms of long-term use and patient compliance. CPAP devices, which deliver pressurized air through a fitted mask worn during sleep, and current pharmacotherapy often face challenges with adherence and discontinuation. For patients who fail to comply with, or are intolerant of these treatments, surgical removal of excess throat tissue to widen the airway may be considered. However, success rates vary, and there are potential risks of surgical, as well as long-term post-surgical complications.
About IHL-42X
IHL-42X is designed to treat OSA by targeting its underlying pathophysiology. An oral fixed-dose combination of dronabinol and acetazolamide, IHL-42X is currently advancing through the RePOSA Phase 2/3 clinical trial, which is expected to enroll more 560 patients at sites worldwide.
Designed to act synergistically, IHL-42X uniquely targets two physiological pathways associated with the intermittent hypoxia (IH) and hypercapnia that characterize OSA. In a prior Australian Phase 2 clinical trial, IHL-42X was shown to reduce the Apnea-Hypopnea Index (AHI) in all dosage strengths, with the lowest dose reducing AHI by an average of 51 percent relative to baseline. RePOSA, a global Phase 2/3 clinical trial is underway, evaluating IHL-42X in individuals with OSA who are either non-compliant, intolerant, or naïve to positive airway pressure devices, including CPAP, with the Phase 2 portion conducted in the United States. A topline readout from the U.S. Phase 2 portion is anticipated in the first half of 2025.
About Incannex Healthcare Inc.
Incannex is leading the way in developing combination medicines that target the underlying biological pathways associated with chronic conditions, including obstructive sleep apnea, rheumatoid arthritis and generalized anxiety disorder. The company is advancing three clinical-stage product candidates based on evidence-based innovation, and supported by streamlined operations. Incannex's lead clinical program, IHL-42X, is an oral fixed-dose combination of dronabinol and acetazolamide designed to target underlying mechanisms and act synergistically in the treatment of obstructive sleep apnea. In a Phase 2 development program, IHL-675A is an oral fixed-dose combination of cannabidiol and hydroxychloroquine sulfate designed to act synergistically to alleviate inflammatory conditions, such as rheumatoid arthritis. Approved for Phase 2 clinical development, PSX-001 is an oral synthetic psilocybin treatment for the treatment of generalized anxiety disorder. Incannex's programs target disorders that have limited, inadequate, or no approved pharmaceutical treatment options. For additional information on Incannex, please visit our website at www.incannex.com.
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. Examples of forward-looking statements in this press release include statements about, among other things: Incannex's business strategy, future operations; Incannex's ability to execute on its objectives, prospects, or plans, the skills and experience of the newly appointed officer of Incannex and expectations with respect to his future contributions to the Company and statements, evaluations and judgments regarding Incannex's research and development efforts, including any implications that the results of earlier clinical trials will be representative or consistent with later clinical trials or final results; the expected timing of enrollment for these trials and the availability of data or results of these trials, and the potential benefits, safety or of Incannex's drug candidates. Forward-looking statements are statements other than historical facts and relate to future events or circumstances or Incannex's future performance, and they are based on management's current assumptions, expectations, and beliefs concerning future developments and their potential effect on Incannex's business. These forward-looking statements are subject to a number of risks and uncertainties, which may cause the forward-looking events and circumstances described in this press release to not occur, and actual results to differ materially and adversely from those described in or implied by the forward-looking statements. These risks and uncertainties include, among others: the continued availability of financing; Incannex's ability to raise capital to fund continuing operations and to complete capital raising transactions; the impact of any infringement actions or other litigation brought against Incannex; the success of Incannex's development efforts, including Incannex's ability to progress its drug candidates through clinical trials on the timelines expected; competition from other providers and products; that the market for its drug candidates may not grow at the rates anticipated or at all; Incannex's compliance with the various evolving and complex laws and regulations applicable to its business and its industry; and Incannex's ability to protect its proprietary technology and intellectual property; and other factors relating to Incannex's industry, its operations and results of operations. The forward-looking statements made in this press release speak only as of the date of this press release, and Incannex assumes no obligation to update publicly any such forward-looking statements to reflect actual results or to changes in expectations, except as otherwise required by law. Incannex's reports filed with the U.S. Securities and Exchange Commission (SEC) including its annual report on Form 10-K for the fiscal year ended June 30, 2024, filed with the SEC on September 30, 2024, and the other reports it files from time to time, including subsequently filed annual, quarterly and current reports, are made available on Incannex's website upon their filing with the SEC. These reports contain more information about Incannex, its business and the risks affecting its business, as well as its results of operations for the periods covered by the financial results included in this press release. For additional information on Incannex, please visit our website at www.incannex.com.
Contact Information
Jennifer Drew-Bear
Edison Group for Incannex
Jdrew-bear@edisongroup.com
FAQ
When will Incannex (IXHL) release Phase 2 results for its OSA drug IHL-42X?
How many patients are enrolled in IXHL's Phase 2 RePOSA trial for IHL-42X?
What are the dose strengths being tested in IXHL's Phase 2 IHL-42X trial?
How many patients will be included in IXHL's Phase 3 expansion study of IHL-42X?
What is the regulatory pathway for IXHL's IHL-42X sleep apnea treatment?
