Incannex Healthcare Announces Positive Topline Results from Pharmacokinetics (PK) Study of IHL-42X, an Oral Combination Medicine for the Treatment of Obstructive Sleep Apnea
Incannex Healthcare (NASDAQ: IXHL) has announced positive topline results from its pharmacokinetics (PK) study of IHL-42X, a novel oral combination medicine combining dronabinol and acetazolamide for treating Obstructive Sleep Apnea (OSA).
The study demonstrated successful bioavailability of IHL-42X, achieving similar PK profiles and equivalent total drug exposure levels compared to reference listed drugs (RLD). The trial involved 125 participants across two Australian sites, with 114 completing all treatment periods. The study evaluated four treatment regimens: IHL-42X in fasted and fed states, and individual components in fasted states.
Key findings showed no substantial food effect on acetazolamide exposure, though THC exposure increased when IHL-42X was administered with food. Safety results were favorable, with no serious adverse events reported. The data supports a potential FDA 505(b)(2) application and will inform the analysis of upcoming Phase 2/3 clinical trials.
Incannex Healthcare (NASDAQ: IXHL) ha annunciato risultati positivi dai suoi risultati preliminari dello studio di farmacocinetica (PK) di IHL-42X, un nuovo farmaco orale combinato che unisce dronabinolo e acetazolamide per il trattamento dell'apnea ostruttiva del sonno (OSA).
Lo studio ha dimostrato una bioavailability efficace di IHL-42X, raggiungendo profili PK simili e livelli di esposizione totale al farmaco equivalenti rispetto ai farmaci di riferimento (RLD). Il trial ha coinvolto 125 partecipanti in due sedi australiane, con 114 che hanno completato tutti i periodi di trattamento. Lo studio ha valutato quattro regimi di trattamento: IHL-42X a digiuno e con cibo, e i componenti individuali a digiuno.
I principali risultati hanno mostrato che non vi erano effetti significativi del cibo sull'esposizione all'acetazolamide, sebbene l'esposizione al THC aumentasse quando IHL-42X veniva somministrato con cibo. I risultati di sicurezza sono stati favorevoli, senza eventi avversi gravi riportati. I dati supportano una potenziale domanda FDA 505(b)(2) e informeranno l'analisi dei prossimi trial clinici di Fase 2/3.
Incannex Healthcare (NASDAQ: IXHL) ha anunciado resultados positivos preliminares de su estudio de farmacocinética (PK) sobre IHL-42X, un novedoso medicamento combinado oral que combina dronabinol y acetazolamida para el tratamiento de la apnea obstructiva del sueño (OSA).
El estudio demostró una bio disponibilidad exitosa de IHL-42X, logrando perfiles PK similares y niveles equivalentes de exposición total al fármaco en comparación con los medicamentos de referencia (RLD). El ensayo incluyó a 125 participantes en dos sitios de Australia, con 114 completando todos los períodos de tratamiento. El estudio evaluó cuatro regímenes de tratamiento: IHL-42X en estado de ayuno y alimentado, y los componentes individuales en estado de ayuno.
Los hallazgos clave mostraron que no hubo un efecto significativo de los alimentos en la exposición a la acetazolamida, aunque la exposición al THC aumentó cuando se administró IHL-42X con alimentos. Los resultados de seguridad fueron favorables, sin eventos adversos graves reportados. Los datos apoyan una posible aplicación FDA 505(b)(2) e informarán el análisis de los próximos ensayos clínicos de Fase 2/3.
Incannex Healthcare (NASDAQ: IXHL)는 IHL-42X의 약물동태학(PK) 연구 결과가 긍정적이라는 발표를 하였습니다. 이는 드로나비놀과 아세타졸라미드를 결합하여 폐쇄성 수면무호흡증(OSA)을 치료하는 새로운 경구 복합약물입니다.
이 연구는 IHL-42X의 성공적인 생체이용률을 입증하였으며, 기준 약물(RLD)과 유사한 PK 프로파일과 동등한 전체 약물 노출 수준을 기록하였습니다. 이 시험은 두 개의 호주 사이트에서 125명의 참가자를 대상으로 진행되었으며, 그 중 114명이 모든 치료 기간을 완료하였습니다. 연구는 공복 및 식사 후 상태에서 IHL-42X와 각 개별 성분을 공복 상태에서 평가하였습니다.
주요 결과는 아세타졸라미드 노출에 대한 음식의 실질적인 영향이 없음을 보여주었지만, IHL-42X가 음식과 함께 투여될 때 THC 노출이 증가하는 것으로 나타났습니다. 안전성 결과는 긍정적이었으며, 심각한 부작용은 보고되지 않았습니다. 이 데이터는 잠재적인 FDA 505(b)(2) 신청을 지원하며 향후 2/3 단계 임상 시험 분석에 도움이 될 것입니다.
Incannex Healthcare (NASDAQ: IXHL) a annoncé des résultats préliminaires positifs de son étude de pharmacocinétique (PK) sur IHL-42X, un nouveau médicament combiné oral associant dronabinol et acétazolamide pour le traitement de l'apnée obstructive du sommeil (OSA).
L'étude a démontré une biodisponibilité réussie de l'IHL-42X, atteignant des profils PK similaires et des niveaux d'exposition totale au médicament équivalents par rapport aux médicaments de référence (RLD). L'essai a impliqué 125 participants dans deux sites australiens, dont 114 ont terminé toutes les périodes de traitement. L'étude a évalué quatre régimes de traitement : IHL-42X à jeun et avec nourriture, ainsi que les composants individuels à jeun.
Les principales conclusions ont montré qu'il n'y avait pas d'effet significatif de la nourriture sur l'exposition à l'acétazolamide, bien que l'exposition au THC augmente lorsque l'IHL-42X était administré avec de la nourriture. Les résultats de sécurité étaient favorables, sans événements indésirables graves signalés. Les données soutiennent une potentielle demande FDA 505(b)(2) et informeront l'analyse des prochains essais cliniques de phase 2/3.
Incannex Healthcare (NASDAQ: IXHL) hat positive vorläufige Ergebnisse aus seiner pharmakokinetischen (PK) Studie zu IHL-42X bekannt gegeben, einem neuartigen oralen Kombinationsmedikament, das Dronabinol und Acetazolamid zur Behandlung von obstruktiver Schlafapnoe (OSA) kombiniert.
Die Studie zeigte eine erfolgreiche Bioverfügbarkeit von IHL-42X und erreichte ähnliche PK-Profile sowie äquivalente Gesamtmedikamentenexpositionsstufen im Vergleich zu den genannten Referenzmedikamenten (RLD). Die Studie umfasste 125 Teilnehmer an zwei australischen Standorten, von denen 114 alle Behandlungsphasen abgeschlossen haben. Es wurden vier Behandlungsregime evaluiert: IHL-42X in nüchternem und gefüttertem Zustand sowie die einzelnen Komponenten im nüchternen Zustand.
Die wichtigsten Ergebnisse zeigten keinen signifikanten Nahrungseffekt auf die Acetazolamid-Exposition, obwohl die THC-Exposition zunahm, wenn IHL-42X zusammen mit Nahrung verabreicht wurde. Die Sicherheitsdaten waren positiv, ohne schwerwiegende unerwünschte Ereignisse. Die Daten unterstützen eine potenzielle FDA 505(b)(2) Anwendung und werden die Analyse der bevorstehenden Phase 2/3 klinischen Studien informieren.
- Successful demonstration of IHL-42X bioavailability with equivalent drug exposure to reference products
- Positive safety profile with no serious adverse events reported
- Data supports potential FDA 505(b)(2) application pathway, which could expedite approval process
- High study completion rate (91.2%) with 114 out of 125 participants completing all treatment periods
- Increased THC exposure when administered with food compared to fasted state
- Higher rate of Treatment-Emergent Adverse Events with IHL-42X (57.4%) compared to acetazolamide alone (37.8%)
Insights
The positive pharmacokinetics results for IHL-42X represent a significant milestone in Incannex's development pipeline. The study's demonstration of bioequivalence to reference listed drugs (RLDs) is particularly noteworthy for three key reasons:
First, the 505(b)(2) pathway confirmation could substantially reduce development time and costs. This regulatory route allows Incannex to leverage existing safety data from the individual components (dronabinol and acetazolamide), potentially saving years of development time and millions in research costs.
Second, the safety profile shows promising characteristics:
- 57.4% TEAE rate in fasted state, comparable to dronabinol alone (52.1%)
- Lower TEAE rate with acetazolamide (37.8%)
- Minimal food effect impact on safety profile
Third, the bioavailability confirmation and food effect findings are important for the Obstructive Sleep Apnea (OSA) market, where current treatment options are primarily to CPAP devices and surgical interventions. An oral therapeutic option could address a significant unmet need in a market projected to reach
The data strongly positions IHL-42X for the upcoming Phase 2/3 RePOSA trial. The robust PK profile and established safety parameters will inform dosing strategies and potentially increase the probability of clinical success. However, investors should note that while these results are encouraging, the critical efficacy data from the Phase 2/3 trial will ultimately determine commercial viability.
- Demonstrated bioavailability of IHL-42X, Incannex’s proprietary combination formulation, confirming delivery of both dronabinol and acetazolamide
- Achieved similar PK and equivalent total drug exposure levels of IHL-42X and the reference listed drugs (RLD) for dronabinol and acetazolamide, building a scientific bridge to established safety and toxicology data with the potential to support a future FDA 505(b)(2) new drug application (NDA)
- Pharmacokinetic results for IHL-42X will inform analysis of anticipated Phase 2/3 data assessing IHL-42X in patients with obstructive sleep apnea
- Continued excellent safety and tolerability findings, with no serious adverse events reported
NEW YORK and MELBOURNE, Australia, Jan. 23, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex), a clinical-stage biopharmaceutical company leading the way in developing combination medicines, today announced positive topline results from a completed pharmacokinetics (PK) and safety study of IHL-42X, a novel, oral fixed-dose combination of acetazolamide and dronabinol for the treatment of Obstructive Sleep Apnea (OSA).
“The topline IHL-42X PK findings we are reporting today provide data necessary to support a 505(b)(2) application in accordance with FDA guidance, assuming continued positive results from our Phase 2 and 3 clinical trials,” said Mark Bleackley, Ph.D., Incannex’s Chief Scientific Officer. “The trial results are consistent with our expectations and the objectives for IHL-42X, a novel, oral fixed-dose combination therapeutic.”
The study confirmed bioavailability of IHL-42X, demonstrating delivery of both dronabinol and acetazolamide. The PK profile of IHL-42X was similar to those observed for the respective RLDs, including equivalent total exposure levels observed for the drug molecules. Furthermore, administration of IHL-42X with food, in contrast to fasted conditions, indicated no substantial food effect on overall exposure to acetazolamide. Consistent with what is known for the RLD, an increase in overall exposure to THC was observed when IHL-42X was administered with food compared to fasted state. No serious adverse events were reported during the study. All but one Treatment-Emergent Adverse Event (TEAE) was reported to be mild or moderate. The proportion of subjects reporting at least one TEAE on the IHL-42X fasted period (
This data establishes a scientific bridge to the reference listed drugs (RLD), potentially enabling the Company to leverage existing safety and toxicology data in a FDA 505(b)2 new drug application for IHL-42X, and assist in the analysis of the global Phase 2/3 RePOSA trial.
The study was designed to assess the safety and pharmacokinetics of IHL-42X, a novel combination formulation, as compared to its respective FDA reference listed drugs. Conducted as a randomized, four-period crossover study in healthy volunteers at two sites in Australia, the trial involved 125 participants, 114 of whom completed all treatment periods. Each treatment period involved the administration of one of four regimens: IHL-42X (dronabinol 5 mg, acetazolamide 250 mg) in fasted or fed state, dronabinol (5 mg) in a fasted state, or acetazolamide (250 mg) in a fasted state. Subjects were assigned to one of four sequences, with each sequence following a distinct order.
About IHL-42X
IHL-42X, an oral fixed-dose combination of acetazolamide and dronabinol, is currently in Phase 2/3 clinical studies for the treatment of obstructive sleep apnea (OSA). Designed to act synergistically, IHL-42X targets two different 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. The expanded Phase 3 portion will include sites in the United Kingdom and European Union. 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 novel oral fix-dosed treatments and therapeutic regimens based on evidence-based innovation. Incannex's lead Phase 2/3 and Phase 2 clinical programs include IHL-42X, an oral fixed-dose combination of dronabinol and acetazolamide, designed to act synergistically in the treatment of OSA for the treatment of obstructive sleep apnea; IHL-675A, an oral fixed-dose combination of cannabidiol and hydroxychloroquine sulfate, acting synergistically to alleviate inflammation, and PSX-001, an oral synthetic psilocybin treatment in combination with psychotherapy, for the treatment of generalized anxiety disorder. Incannex's programs target disorders that have limited, inadequate, or no approved pharmaceutical treatment options.
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.
Contact Information
Jennifer Drew-Bear
Edison Group for Incannex
Jdrew-bear@edisongroup.com
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