Incannex Reports Positive Topline Results from RePOSA Phase 2 Trial of IHL-42X
Incannex Healthcare (NASDAQ:IXHL) has announced positive topline results from its RePOSA Phase 2 clinical trial for IHL-42X, a novel oral drug candidate for obstructive sleep apnea (OSA). The trial demonstrated significant improvements in key endpoints, with the drug reducing the Apnoea-Hypopnoea Index (AHI) by up to 83% in the high-dose group and 79% in the low-dose group.
The study, involving 121 adult participants, showed statistically significant improvements across multiple measures including oxygen desaturation, sleep quality, and patient-reported outcomes. Both dosage groups demonstrated strong efficacy, with 33.3% to 41.2% of patients achieving >30% AHI reduction. The drug exhibited an excellent safety profile with no serious adverse events reported.
Following these positive results, Incannex is preparing for an End-of-Phase 2 meeting with the FDA to discuss the path toward Phase 3 trials and potential commercialization.
[ "Significant AHI reduction of up to 83% from baseline in high-dose group", "33.3% to 41.2% of patients achieved >30% reduction in AHI across dose groups", "Statistically significant improvements in oxygen desaturation and patient-reported outcomes", "Excellent safety profile with no serious adverse events reported", "Strong potential as first oral pharmaceutical treatment for 900M+ global OSA patients" ]Incannex Healthcare (NASDAQ:IXHL) ha annunciato risultati positivi preliminari dal suo studio clinico di Fase 2 RePOSA per IHL-42X, un nuovo farmaco orale candidato per il trattamento dell'apnea ostruttiva del sonno (OSA). Lo studio ha mostrato miglioramenti significativi negli endpoint chiave, con una riduzione dell'Indice Apnea-Ipopnea (AHI) fino all'83% nel gruppo ad alta dose e al 79% nel gruppo a bassa dose.
La ricerca, condotta su 121 partecipanti adulti, ha evidenziato miglioramenti statisticamente significativi in diverse misure, tra cui la desaturazione di ossigeno, la qualità del sonno e gli esiti riportati dai pazienti. Entrambi i gruppi di dosaggio hanno mostrato una forte efficacia, con dal 33,3% al 41,2% dei pazienti che hanno ottenuto una riduzione dell'AHI superiore al 30%. Il farmaco ha dimostrato un eccellente profilo di sicurezza senza eventi avversi gravi segnalati.
In seguito a questi risultati positivi, Incannex si sta preparando per un incontro di fine Fase 2 con la FDA per discutere il percorso verso le prove di Fase 3 e la possibile commercializzazione.
- Riduzione significativa dell'AHI fino all'83% rispetto al basale nel gruppo ad alta dose
- Dal 33,3% al 41,2% dei pazienti ha ottenuto una riduzione dell'AHI superiore al 30% nei vari gruppi di dosaggio
- Miglioramenti statisticamente significativi nella desaturazione di ossigeno e negli esiti riferiti dai pazienti
- Eccellente profilo di sicurezza senza eventi avversi gravi riportati
- Forte potenziale come primo trattamento farmaceutico orale per oltre 900 milioni di pazienti OSA nel mondo
Incannex Healthcare (NASDAQ:IXHL) ha anunciado resultados positivos preliminares de su ensayo clínico de Fase 2 RePOSA para IHL-42X, un nuevo medicamento oral candidato para la apnea obstructiva del sueño (AOS). El estudio mostró mejoras significativas en los puntos finales clave, reduciendo el Índice de Apnea-Hipopnea (IAH) hasta en un 83% en el grupo de alta dosis y un 79% en el grupo de baja dosis.
El estudio, con 121 participantes adultos, evidenció mejoras estadísticamente significativas en múltiples medidas, incluyendo la desaturación de oxígeno, la calidad del sueño y los resultados reportados por los pacientes. Ambos grupos de dosis demostraron una fuerte eficacia, con un 33.3% a 41.2% de los pacientes logrando una reducción del IAH superior al 30%. El medicamento mostró un excelente perfil de seguridad sin eventos adversos graves reportados.
Tras estos resultados positivos, Incannex se prepara para una reunión de fin de Fase 2 con la FDA para discutir el camino hacia los ensayos de Fase 3 y la posible comercialización.
- Reducción significativa del IAH hasta un 83% desde la línea base en el grupo de alta dosis
- Del 33.3% al 41.2% de los pacientes lograron una reducción del IAH superior al 30% en los grupos de dosis
- Mejoras estadísticamente significativas en la desaturación de oxígeno y resultados reportados por los pacientes
- Excelente perfil de seguridad sin eventos adversos graves reportados
- Gran potencial como primer tratamiento farmacéutico oral para más de 900 millones de pacientes con AOS en todo el mundo
Incannex Healthcare (NASDAQ:IXHL)는 폐쇄성 수면 무호흡증(OSA) 치료를 위한 새로운 경구 약물 후보인 IHL-42X의 RePOSA 2상 임상시험에서 긍정적인 주요 결과를 발표했습니다. 시험 결과 핵심 지표에서 유의미한 개선을 보였으며, 고용량 그룹에서 무호흡-저호흡 지수(AHI)를 최대 83%, 저용량 그룹에서 79% 감소시켰습니다.
121명의 성인 참가자를 대상으로 한 연구에서 산소 포화도 저하, 수면 질, 환자 보고 결과 등 여러 측면에서 통계적으로 유의한 개선이 확인되었습니다. 두 용량 그룹 모두 강력한 효능을 보였으며, 33.3%에서 41.2%의 환자가 AHI를 30% 이상 감소시켰습니다. 약물은 심각한 부작용 없이 우수한 안전성을 나타냈습니다.
이러한 긍정적인 결과를 바탕으로 Incannex는 FDA와 2상 종료 회의를 준비 중이며, 3상 시험 및 상용화 방안에 대해 논의할 예정입니다.
- 고용량 그룹에서 기준치 대비 최대 83%의 AHI 유의미 감소
- 용량 그룹별로 33.3%에서 41.2%의 환자가 AHI 30% 이상 감소 달성
- 산소 포화도 저하 및 환자 보고 결과에서 통계적 유의성 확보
- 심각한 부작용 없는 우수한 안전성 프로필
- 전 세계 9억 명 이상의 OSA 환자를 위한 최초의 경구 약물 치료제로서 강력한 잠재력
Incannex Healthcare (NASDAQ:IXHL) a annoncé des résultats positifs préliminaires de son essai clinique de phase 2 RePOSA pour IHL-42X, un nouveau candidat médicament oral pour l'apnée obstructive du sommeil (AOS). L'étude a démontré des améliorations significatives sur les critères principaux, avec une réduction de l'Indice Apnée-Hypopnée (IAH) allant jusqu'à 83 % dans le groupe à dose élevée et 79 % dans le groupe à dose faible.
Cette étude, réalisée auprès de 121 participants adultes, a montré des améliorations statistiquement significatives sur plusieurs mesures, notamment la désaturation en oxygène, la qualité du sommeil et les résultats rapportés par les patients. Les deux groupes de dosage ont présenté une forte efficacité, avec 33,3 % à 41,2 % des patients ayant obtenu une réduction de l'IAH supérieure à 30 %. Le médicament a affiché un excellent profil de sécurité sans événements indésirables graves rapportés.
Suite à ces résultats positifs, Incannex se prépare à une réunion de fin de phase 2 avec la FDA pour discuter de la voie vers les essais de phase 3 et la commercialisation potentielle.
- Réduction significative de l'IAH jusqu'à 83 % par rapport au départ dans le groupe à dose élevée
- 33,3 % à 41,2 % des patients ont obtenu une réduction de l'IAH supérieure à 30 % dans les groupes de dose
- Améliorations statistiquement significatives de la désaturation en oxygène et des résultats rapportés par les patients
- Excellent profil de sécurité sans événements indésirables graves
- Fort potentiel en tant que premier traitement pharmaceutique oral pour plus de 900 millions de patients atteints d'AOS dans le monde
Incannex Healthcare (NASDAQ:IXHL) hat positive Zwischenergebnisse aus seiner Phase-2-Studie RePOSA für IHL-42X, einen neuartigen oralen Wirkstoffkandidaten zur Behandlung der obstruktiven Schlafapnoe (OSA), bekannt gegeben. Die Studie zeigte signifikante Verbesserungen bei wichtigen Endpunkten, wobei der Wirkstoff den Apnoe-Hypopnoe-Index (AHI) in der Hochdosisgruppe um bis zu 83 % und in der Niedrigdosisgruppe um 79 % senkte.
Die Studie mit 121 erwachsenen Teilnehmern zeigte statistisch signifikante Verbesserungen in mehreren Bereichen, darunter Sauerstoffentsättigung, Schlafqualität und patientenberichtete Ergebnisse. Beide Dosierungsgruppen zeigten eine starke Wirksamkeit, wobei 33,3 % bis 41,2 % der Patienten eine AHI-Reduktion von mehr als 30 % erreichten. Das Medikament wies ein ausgezeichnetes Sicherheitsprofil auf, ohne schwerwiegende unerwünschte Ereignisse.
Nach diesen positiven Ergebnissen bereitet Incannex ein End-of-Phase-2-Meeting mit der FDA vor, um den Weg zu Phase-3-Studien und einer möglichen Kommerzialisierung zu besprechen.
- Signifikante AHI-Reduktion von bis zu 83 % gegenüber dem Ausgangswert in der Hochdosisgruppe
- 33,3 % bis 41,2 % der Patienten erreichten >30 % AHI-Reduktion in den Dosierungsgruppen
- Statistisch signifikante Verbesserungen bei Sauerstoffentsättigung und patientenberichteten Ergebnissen
- Ausgezeichnetes Sicherheitsprofil ohne schwerwiegende unerwünschte Ereignisse
- Starkes Potenzial als erste orale pharmazeutische Behandlung für über 900 Millionen OSA-Patienten weltweit
- None.
- Full Clinical Study Report still pending completion
- FDA approval pathway and Phase 3 trial design yet to be determined
Insights
Incannex's IHL-42X shows impressive Phase 2 results for sleep apnea with strong efficacy and safety, positioning it as a potential first-in-class oral therapy.
The RePOSA Phase 2 trial results for IHL-42X represent a significant milestone in OSA treatment development. With 83% maximum AHI reduction in the high-dose group and 79% in the low-dose group, these efficacy metrics exceed typical thresholds considered clinically meaningful in sleep medicine. Particularly notable is that 41.2% of high-dose patients achieved >30% AHI reduction, while 14.7% saw reductions exceeding 50% - these response rates identify a substantial responder population.
What's most compelling is the multi-dimensional efficacy profile. Beyond the primary AHI endpoint, IHL-42X demonstrated improvements across patient-reported outcomes (FOSQ-10, PROMIS, ESS) and objective polysomnography parameters like Oxygen Desaturation Index and Wake After Sleep Onset. The 29.8% reduction in WASO is particularly valuable as fragmented sleep significantly impacts daytime functioning and quality of life.
The clean safety profile further distinguishes IHL-42X in the OSA therapeutic landscape. Current non-CPAP options like oral appliances and hypoglossal nerve stimulation carry significant compliance limitations and side effects. An oral medication with this safety profile addresses a critical unmet need for the estimated 900 million OSA patients globally.
From a clinical development perspective, these Phase 2 results position IHL-42X favorably for Phase 3 planning. The defined responder population suggests potential for a targeted approach that could optimize trial design and eventual patient selection. The upcoming End-of-Phase 2 FDA meeting will be crucial for determining whether additional dose-finding work is needed or if the program can advance directly to pivotal trials.
The RePOSA trial results represent a potential inflection point for Incannex's valuation and commercial prospects. In the $10+ billion global OSA market, there remains a glaring absence of FDA-approved oral pharmacotherapies, creating a substantial opportunity for first-movers with compelling clinical data.
What makes these results particularly strong from a commercial perspective is the dual achievement of statistical significance and clinically meaningful benefits across both objective measures and patient-reported outcomes. The 83% maximum AHI reduction and statistically significant improvements in patient-reported fatigue and sleep-related impairment directly address the core symptoms that drive patients to seek treatment.
The responder analysis showing 33.3% (low-dose) and 41.2% (high-dose) of patients achieving >30% AHI reduction provides critical information for commercial modeling. Even capturing a fraction of the estimated 900 million global OSA patients could translate to blockbuster potential.
From a regulatory perspective, the statistically significant improvements in multiple endpoints strengthen Incannex's position for the upcoming End-of-Phase 2 FDA meeting. The absence of serious adverse events and low frequency of treatment-emergent adverse effects will likely facilitate regulatory discussions around accelerated development pathways.
For investors, these results significantly de-risk the IHL-42X program. With positive Phase 2 data and a clear path to Phase 3, Incannex is positioned at a critical value-creation inflection point. The mention of ongoing commercial discussions suggests potential partnership interest, which could provide external validation and non-dilutive capital to fund Phase 3 development. Successful commercialization in this underserved market could transform Incannex from a clinical-stage biotech into a commercial entity with substantial revenue potential.
Statistically and clinically significant improvements across key clinical endpoints; IHL-42X reduced AHI by up to
NEW YORK and MELBOURNE, Australia, July 30, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”) is excited to share positive topline results from its RePOSA Phase 2 clinical trial evaluating IHL-42X, a novel oral drug candidate for obstructive sleep apnoea (OSA). With over 900 million people affected globally and no approved oral pharmaceutical treatments currently available, IHL-42X’s robust efficacy and exceptional safety profile position it as a potential transformative therapy for OSA patients worldwide. The results confirm statistically significant and clinically meaningful improvements across key endpoints assessed in the study, reinforcing IHL-42x’s potential as a best-in-class therapy for patients with OSA.
Compelling Clinical Efficacy
The RePOSA Phase 2 trial demonstrated clear statistically and clinically significant improvements across multiple key endpoints for patients receiving IHL-42X compared to placebo, highlighting its potential to reduce OSA severity and enhance patient quality of life:
- Apnoea-Hypopnoea Index (AHI): The low-dose and high-dose IHL-42X groups achieved a statistically significant reduction in percent change in AHI from baseline compared to placebo (p<0.05), the primary measure of OSA severity. Maximum reductions in AHI were observed at up to
83% for the high-dose group and up to79% for the low-dose group. Notably,33.3% of patients in the low-dose group and41.2% in the high-dose group achieved a greater than30% reduction in AHI, while13.9% (low-dose) and14.7% (high-dose) experienced reductions exceeding50% —demonstrating a strong therapeutic response in a substantial subset of the population. - Patient Global Impression of Change (PGI-C) Sleep related impairment: The low-dose IHL-42X group showed statistically significant improvement (p<0.05), reflecting meaningful patient-perceived benefits.
- PGI-C Fatigue: Statistically significant improvement in the low-dose group, suggesting enhanced daytime alertness and reduced fatigue.
- Oxygen Desaturation Index (ODI): Both low- and high-dose groups demonstrated statistically significant improvements, indicating better oxygenation during sleep.
- Patient-Reported Outcomes: IHL-42X led to clinically significant improvements in patient-reported outcome measures, including the Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10), PROMIS Sleep-Related Impairment 8a (PROMIS-SRI 8a), PROMIS Fatigue 7a, and Epworth Sleepiness Scale (ESS) in both low- and high-dose groups, demonstrating enhanced sleep quality, reduced daytime fatigue, and improved daily functioning for patients with OSA.
- Polysomnography (PSG) Metrics: IHL-42X drastically improved objective sleep parameters as measured by PSG.
- Wake After Sleep Onset (WASO): Reduced by
29.8% in the high-dose arm, meaning patients spent less time awake during the night. - AHI During Supine Sleep: Decreased by
30.3% in the high-dose arm, a critical improvement given supine sleep exacerbates apneic events.
- Wake After Sleep Onset (WASO): Reduced by
These results collectively demonstrate IHL-42X’s ability to address both objective and subjective aspects of OSA, offering compelling clinical benefits to patients.
Outstanding Safety Profile
IHL-42X was well tolerated across both low- and high-dose cohorts. No serious adverse events were reported during the treatment period, and treatment-emergent adverse effects (TEAEs) were infrequent, with the majority being mild or moderate in severity. This excellent safety profile supports IHL-42X’s potential for broad patient use.
Joel Latham, CEO and President of Incannex, commented: "We are extremely pleased with the RePOSA trial results. The combination of statistically significant improvements across multiple endpoints and an outstanding safety profile positions IHL-42X as one of the most compelling drug candidates in the global race to bring a pharmaceutical treatment for OSA to market. The depth of response seen in a defined subset of patients further reinforces our belief in its clinical and commercial potential. These results are a clear signal of the strength of our development strategy and a critical step forward in building long-term shareholder value. We continue to facilitate commercial discussions and look forward to providing shareholders with an update in this regard soon."
Dr. Mark Bleackley, Chief Scientific Officer of Incannex, added:
“These findings highlight the statistically significant treatment effects observed across multiple measures of disease severity and patient experience. Combined with an excellent safety and tolerability profile, the results provide strong validation of IHL-42X’s potential as an innovative and impactful therapy for obstructive sleep apnea.”
Next Steps
With positive Phase 2 data in hand, Incannex is now focused on advancing IHL-42X toward commercial readiness. Preparations are in progress for the Company’s End-of-Phase 2 meeting with the FDA, where discussions will focus on identifying the most efficient and effective path to registration. This engagement is expected to provide critical guidance for optimising the Phase 3 trial design and regulatory strategy.
In parallel, Incannex will continue to evaluate all clinical data and complete the full Clinical Study Report in the coming months. These strategic activities mark a new phase of execution for Incannex as it progresses toward late-stage development and possible future commercialisation.
RePOSA Phase 2 Trial Overview
The RePOSA Phase 2 trial was a randomized, double-blind, placebo-controlled clinical study designed to evaluate the safety, tolerability, and efficacy of IHL-42X, a novel oral drug candidate for the treatment of obstructive sleep apnoea (OSA). The study enrolled 121 adult participants with confirmed moderate to severe OSA, who were randomized to receive either a high dose, low dose, or placebo version of IHL-42X for a 28-day treatment period. Efficacy was assessed using both objective and patient-reported outcome measures aligned with FDA guidance, including the primary endpoint of change in Apnea-Hypopnoea Index (AHI) as measured by polysomnography (PSG). Key secondary endpoints included the Oxygen Desaturation Index (ODI), Patient Global Impression of Change (PGI-C), Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ-10), and PROMIS fatigue and sleep-related impairment scores. The study was designed to generate high-quality clinical data to support the advancement of IHL-42X into Phase 3 development and regulatory discussions.
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. Forward-looking statements are statements other than historical facts and relate to future events, future circumstances and Incannex's future performance. These statements are based on management's current assumptions, expectations, and beliefs. 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, commercial discussions or plans; evaluations and judgments regarding Incannex's research and development efforts and potential future commercialization, including any implications that the results of earlier clinical trials or interim or topline results (such as the topline results of the RePOSA Phase 2 Study) will be representative or consistent with a full Clinical Study Report, later clinical trials or their respective interim or final results; the potential benefits and safety of Incannex's drug candidates and the market opportunity for these candidates; and potential shareholder value. 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, to complete capital raising transactions and to maintain or potentially further improve its capital structure; Incannex’s ability to maintain the listing of its shares of common stock on the Nasdaq Stock Market; 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 (including its ability to successfully complete the Phase 3 trial for IHL-42) and to obtain necessary regulatory approvals for commercialization of its product candidates, including IHL-42; the effects of competition from other providers and products as currently existing or that may be developed in the future; that the market for its drug candidates may not grow at the rates anticipated or at all or that estimates for these markets may ultimately be incorrect; that Incannex may be unable to successfully execute upon any commercial discussions; Incannex's ability to comply 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 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.
Investor & Media Contacts
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