Dosing completed in 115 participant bioavailability/bioequivalence clinical trial for proprietary sleep apnea drug candidate IHL-42X
Incannex Healthcare (Nasdaq: IXHL) has completed participant dosing in the IHL-42X Bioavailability/Bioequivalence (BA/BE) clinical trial for its proprietary sleep apnea drug candidate. The study involved 115 participants who completed four treatment periods, comparing IHL-42X to FDA reference listed drugs Marinol and Taro acetazolamide. No serious adverse events were reported during the study.
IHL-42X, a fixed dose combination of dronabinol and acetazolamide, targets obstructive sleep apnea (OSA), a condition affecting millions in the USA with no registered pharmaceutical treatment. The trial's data will be analyzed to generate comparative pharmacokinetic profiles, potentially allowing Incannex to rely on existing safety and toxicology data for future regulatory submissions.
Concurrently, the Phase 2/3 FDA IND-enabling RePOSA clinical trial for IHL-42X continues, having commenced dosing in May 2024.
Incannex Healthcare (Nasdaq: IXHL) ha completato la somministrazione ai partecipanti nel trial clinico di Bioavailability/Bioequivalence (BA/BE) IHL-42X per il suo candidato farmaco proprietario contro l'apnea notturna. Lo studio ha coinvolto 115 partecipanti che hanno completato quattro periodi di trattamento, confrontando IHL-42X con i farmaci di riferimento elencati dalla FDA, Marinol e Taro acetazolamide. Durante lo studio, non sono stati segnalati eventi avversi gravi.
IHL-42X, una combinazione a dose fissa di dronabinolo e acetazolamide, mira a trattare l'apnea notturna ostruttiva (OSA), una condizione che colpisce milioni di persone negli Stati Uniti senza trattamenti farmacologici registrati. I dati del trial saranno analizzati per generare profili farmacocinetici comparativi, permettendo a Incannex di fare riferimento ai dati di sicurezza e tossicologia esistenti per future sottomissioni regolatorie.
In concomitanza, il trial clinico di Fase 2/3 RePOSA abilitante per l'IND della FDA per IHL-42X continua, essendo iniziata la somministrazione a maggio 2024.
Incannex Healthcare (Nasdaq: IXHL) ha completado la dosificación de participantes en el ensayo clínico de Bioavailability/Bioequivalence (BA/BE) IHL-42X para su candidato a medicamento contra la apnea del sueño. El estudio involucró 115 participantes que completaron cuatro períodos de tratamiento, comparando IHL-42X con los medicamentos de referencia listados por la FDA, Marinol y Taro acetazolamida. No se informaron eventos adversos graves durante el estudio.
IHL-42X, una combinación de dosis fija de dronabinol y acetazolamida, tiene como objetivo tratar la apnea obstructiva del sueño (OSA), una condición que afecta a millones en EE. UU. sin tratamiento farmacológico registrado. Los datos del ensayo serán analizados para generar perfiles farmacocinéticos comparativos, permitiendo a Incannex apoyarse en los datos existentes de seguridad y toxicología para futuras presentaciones regulatorias.
Al mismo tiempo, el ensayo clínico de Fase 2/3 habilitante para la FDA RePOSA para IHL-42X continúa, habiéndose iniciado la dosificación en mayo de 2024.
Incannex Healthcare(Nasdaq: IXHL)는 자사의 독점적인 수면 무호흡증 약물 후보에 대한 IHL-42X 약물의 생체 이용률 및 생체 동등성(Bioavailability/Bioequivalence, BA/BE) 임상 시험의 참가자 투약을 완료했습니다. 이 연구에는 115명의 참가자가 포함되어 있으며, IHL-42X를 FDA 승인 약물인 Marinol 및 Taro 아세타졸라마이드와 비교하는 네 가지 치료 기간을 완료했습니다. 연구 기간 동안 심각한 부작용은 보고되지 않았습니다.
IHL-42X는 드로나비놀과 아세타졸라마이드의 고정 용량 조합으로, 미국에서 수백만 명에게 영향을 미치는 폐쇄성 수면 무호흡증(OSA)을 목표로 합니다. 임상 시험 데이터는 비교 약리학적 프로파일을 생성하기 위해 분석되며, Incannex가 향후 규제 제출을 위해 기존의 안전성과 독성 데이터를 활용할 수 있도록 할 수 있습니다.
동시에 IHL-42X의 2/3상 FDA IND 승인 임상 시험 RePOSA는 2024년 5월 투약을 시작으로 계속 진행 중입니다.
Incannex Healthcare (Nasdaq: IXHL) a terminé l'administration aux participants dans l'
IHL-42X, une combinaison à dose fixe de dronabinol et d'acétazolamide, cible l'apnée obstructive du sommeil (OSA), une condition qui touche des millions de personnes aux États-Unis sans traitement pharmaceutique enregistré. Les données de l'essai seront analysées pour générer des profils pharmacocinétiques comparatifs, permettant potentiellement à Incannex de s'appuyer sur les données de sécurité et de toxicologie existantes pour de futures soumissions réglementaires.
Parallèlement, l'
Incannex Healthcare (Nasdaq: IXHL) hat die Dosisverabreichung an Teilnehmern in der IHL-42X Bioverfügbarkeits-/Bioäquivalenzstudie (BA/BE) für seinen proprietären Medikamentenkandidaten gegen Schlafapnoe abgeschlossen. In der Studie nahmen 115 Teilnehmer an vier Behandlungsperioden teil, wobei IHL-42X mit den von der FDA als Referenz gelisteten Arzneimitteln Marinol und Taro Acetazolamid verglichen wurde. Während der Studie wurden keine schweren unerwünschten Ereignisse gemeldet.
IHL-42X, eine Fixkombination aus Dronabinol und Acetazolamid, zielt auf obstruktive Schlafapnoe (OSA) ab, eine Erkrankung, die Millionen Menschen in den USA betrifft und für die es keine registrierte pharmazeutische Therapie gibt. Die Studiendaten werden analysiert, um vergleichbare pharmakokinetische Profile zu erstellen, was Incannex möglicherweise ermöglichen könnte, sich auf bestehende Sicherheits- und Toxizitätsdaten für zukünftige regulatorische Einreichungen zu verlassen.
Gleichzeitig läuft die Phase 2/3 FDA IND-ermächtigende RePOSA-Studie für IHL-42X weiter, die im Mai 2024 mit der Dosisverabreichung begonnen hat.
- Completion of dosing in the BA/BE study with 115 participants
- No serious adverse events reported during the study
- Potential to rely on existing safety and toxicology data for future regulatory submissions
- Ongoing Phase 2/3 FDA IND-enabling RePOSA clinical trial for IHL-42X
- Data analysis from the BA/BE study still pending
- IHL-42X not yet approved or proven effective for OSA treatment
Insights
The completion of dosing in Incannex's bioavailability/bioequivalence (BA/BE) clinical trial for IHL-42X marks a significant milestone in the development of this potential obstructive sleep apnea (OSA) treatment. With 115 participants completing all four treatment periods and no serious adverse events reported, the initial safety profile appears promising.
The study's design, comparing IHL-42X to FDA reference listed drugs Marinol and Taro acetazolamide, is important for several reasons:
- It may allow Incannex to leverage existing safety and toxicology data for the reference drugs, potentially streamlining the regulatory process.
- The food effect assessment on bioavailability could inform future dosing recommendations.
- The pharmacokinetic data across multiple treatment periods will provide valuable insights into the behavior of the drug combination in the body.
However, it's important to note that while this study is a necessary step, it doesn't directly demonstrate efficacy in treating OSA. The ongoing Phase 2/3 FDA IND-enabling RePOSA clinical trial will be more indicative of the drug's potential effectiveness.
The lack of registered pharmaceutical treatments for OSA, which affects millions in the USA alone, presents a significant market opportunity if IHL-42X proves successful in later-stage trials. However, investors should remain cautious as the drug is still in early stages of development and success in BA/BE studies doesn't guarantee clinical efficacy or regulatory approval.
Incannex's progress with IHL-42X is noteworthy in the context of the pharmaceutical industry's approach to combination drugs and cannabinoid-based medications. The fixed-dose combination of dronabinol (synthetic THC) and acetazolamide represents an innovative approach to treating OSA, a condition with a significant unmet medical need.
Key industry implications include:
- Potential for a first-in-class pharmaceutical treatment for OSA, which could disrupt current treatment paradigms dominated by devices like CPAP machines.
- Demonstration of the pharmaceutical potential of cannabinoids when combined with established medications, potentially opening doors for similar approaches in other therapeutic areas.
- The company's strategy of using FDA reference listed drugs may accelerate the development timeline and reduce costs, a important factor in the competitive pharmaceutical landscape.
However, challenges remain:
- Regulatory scrutiny for cannabinoid-based medications remains high and Incannex will need to present robust efficacy and safety data.
- Market acceptance of a pharmaceutical OSA treatment may face resistance from established device manufacturers and require significant education efforts for both healthcare providers and patients.
- The variable pharmacokinetics of cannabinoids, as mentioned by the CSO, could present challenges in achieving consistent therapeutic effects across patient populations.
While the completion of this BA/BE study is a positive step, investors should closely monitor the results of the ongoing Phase 2/3 trial for a clearer picture of IHL-42X's market potential.
- IHL-42X is a fixed dose combination drug targeting obstructive sleep apnea (OSA), a medical condition with no available registered pharmaceutical treatment for millions of sufferers in the USA alone.
- bioavailability/bioequivalence (‘BA/BE’) clinical trial assessed the pharmacokinetics and tolerability of IHL-42X consistent with FDA development plan.
- Analysis of data underway, however, no serious adverse events were reported.
- Phase 2/3 FDA IND-enabling RePOSA clinical trial continues after dosing commenced in May 2024.
NEW YORK and MELBOURNE, Australia, July 30, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex’ or the ‘Company’), a clinical-stage pharmaceutical company developing proprietary medicinal cannabinoid products and psychedelic-assisted psychotherapies, is pleased to announce that it has completed participant dosing in the IHL-42X Bioavailability/Bioequivalence (BA/BE) clinical trial.
IHL-42X comprises two drugs, dronabinol (synthetic delta-9-tetrahydrocannabinol (THC)), and acetazolamide. The BA/BE clinical trial was designed to compare the bioavailability of dronabinol and acetazolamide in IHL-42X as a fixed dose combination drug to the FDA reference listed drugs Marinol and Taro acetazolamide administered in isolation. The BA/BE study also assessed the effect of food on the bioavailability of the drug substances in IHL-42X. All participants in the study completed four treatment periods, each consisting of a single dose each of IHL-42X, Marinol or acetazolamide under fasted conditions, or IHL-42X under fed conditions. Blood samples were then collected at predefined intervals and analysed for levels of acetazolamide, THC and major THC metabolites. Participants were also monitored for adverse events throughout the study. 115 participants completed all four treatment periods and no serious adverse events were reported during the study.
Data collected during the study will be processed and analysed over the coming months. This will generate information on the pharmacokinetics of each of the active pharmaceutical ingredients in IHL-42X compared to the relevant reference listed drugs. These comparative pharmacokinetic profiles will facilitate the Company’s ability to rely on safety and toxicology data for the reference listed drugs in future regulatory submissions. The adverse event data from the BA/BE study will also contribute to the safety profile of IHL-42X as a combination product.
Incannex Chief Scientific Officer Dr Mark Bleackley said “Completion of dosing in the BA/BE study is an important milestone in the IHL-42X research program. The pharmacokinetics of cannabinoids are highly-variable so having data across the four treatment periods from this many subjects will provide incredibly valuable data for Incannex in the continued development of IHL-42X. The ability to rely on safety and toxicology data for the refence listed drugs reduces the burden on Incannex and allows us to focus on safety and efficacy of the drug product in OSA patients. Thank you to the trial sites, our clinical research organisation and, most importantly, the volunteers who participated in the study.”
About IHL-42X
IHL-42X is a synergistic composition of dronabinol, a synthetic form of Delta-9 Tetrahydrocannabinol (THC), and acetazolamide, a carbonic anhydrase inhibitor. Results from a Phase 2 proof of concept clinical trial undertaken by Incannex were published in 2022. Incannex observed that IHL-42X reduced average apnoea-hypopnoea index (‘AHI’) by an average of
About Obstructive Sleep Apnea
Sleep apnea 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 sleep apnea 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 Continuous Positive Airway Pressure (‘CPAP’) machine. However, patient compliance to CPAP 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 CPAP, the global annual market for sleep apnea detection and treatment using CPAP 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
FAQ
What is the purpose of Incannex's IHL-42X Bioavailability/Bioequivalence clinical trial?
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What is the current status of Incannex's Phase 2/3 RePOSA clinical trial for IHL-42X?
