{"success":true,"data":{"pressRelease":{"id":"127093","rtpr_id":"nGNX7zV0cK","ticker":"IXHL","exchange":"NASDAQ","all_tickers":["IXHL"],"title":"Incannex Announces First Patient Dosed in DReAMzz Phase 2 Study of IHL-42X","author":"Globe Newswire","published_at":"2026-08-25T12:46:00.090Z","article_body":"NEW YORK and MELBOURNE, Australia, Aug. 25, 2026 (GLOBE NEWSWIRE) -- Incannex\nHealthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”), a\nclinical-stage biopharmaceutical company developing innovative combination\ntherapies for high-impact indications, today announced that the first patient\nhas been dosed in the DReAMzz Phase 2 dose-optimization study of IHL-42X, the\nCompany’s oral fixed-dose combination drug candidate for the treatment of\nobstructive sleep apnea (“OSA”). The milestone builds on the positive\nresults from the Phase 2 RePOSA study, in which IHL-42X demonstrated\nstatistically significant reductions in apnea-hypopnea index (“AHI”)\ncompared with placebo, with individual reductions in AHI of up to 83% observed\nand exceptional safety profile. \n\nFirst patient dosing represents another significant milestone in the continued\nadvancement of IHL-42X and follows a period of substantial clinical and\nregulatory progress for the program. Over the past year, Incannex has reported\npositive Phase 2 RePOSA results, received Fast Track designation from the U.S.\nFood and Drug Administration (“FDA”), and advanced its regulatory strategy\nfollowing engagement with the FDA. The company’s current focus, the DReAMzz\ndose-optimization study, recently commenced patient screening and has now\nprogressed to active patient dosing. All 14 DReAMzz sites now have approval\nfrom the Institutional Review Board to conduct the study.\n\nThe DReAMzz study is designed to further optimize dose selection for IHL-42X\nand strengthen the clinical and regulatory foundation for the Company’s\nplanned Phase 3 development program.\n\nJoel Latham, President and Chief Executive Officer of Incannex, said:\n\n“Dosing the first patient in DReAMzz is another important milestone for\nIHL-42X and continues a period of significant clinical and regulatory progress\nfor the program.\n\n“The momentum behind IHL-42X has continued to build over the past year. We\ndelivered positive RePOSA results, including statistically significant\nreductions in AHI and individual reductions of up to 83%, secured FDA Fast\nTrack designation, advanced our regulatory strategy and have now commenced\npatient dosing in DReAMzz.\n\n“We believe IHL-42X has the potential to reshape the treatment landscape for\nobstructive sleep apnea. OSA affects hundreds of millions of people globally,\nyet there remains a significant need for an effective oral pharmaceutical\ntreatment. The clinical results generated to date give us increasing\nconfidence in the potential of IHL-42X to address that need.\n\n“Our focus now is execution. DReAMzz is designed to optimize the treatment\nregimen and provide the data required to advance IHL-42X toward Phase 3\ndevelopment. With strong clinical data, FDA Fast Track designation and DReAMzz\nnow actively dosing patients, we believe IHL-42X is exceptionally well\npositioned as we enter this next stage of development.”\n\nFDA Fast Track Designation Supports Continued Development\n\nThe clinical progress of IHL-42X was further reinforced by the FDA granting\nFast Track designation to the program.\n\nFast Track designation is designed to facilitate the development and expedite\nthe review of therapies intended to treat serious conditions and address unmet\nmedical needs. The designation provides opportunities for more frequent\ninteractions with the FDA during development and, subject to applicable\nrequirements, may provide access to mechanisms intended to accelerate\nregulatory review.\n\nThe designation was supported by the safety, efficacy and pharmacokinetic data\ngenerated across the IHL-42X clinical development program, including the\npositive results from the Phase 2 RePOSA study.\n\nIncannex believes Fast Track designation, together with the clinical evidence\ngenerated to date, provides important regulatory support as the Company\nadvances IHL-42X through dose optimization and toward Phase 3 development.\n\nDReAMzz Phase 2 Dose-Optimization Study\n\nDReAMzz is a Phase 2 crossover dose-optimization study designed to further\ncharacterize the dose-response profile of IHL-42X and inform dose selection\nfor subsequent late-stage clinical development.\n\nThe study will evaluate objective sleep-related measures alongside\npatient-reported outcomes, providing additional data intended to refine the\nIHL-42X treatment regimen and strengthen the design of the Company’s planned\nPhase 3 program.\n\nIncannex has established a network of 14 clinical trial sites across the\nUnited States to support execution of DReAMzz. Drug product has been\nmanufactured, regulatory and operational preparations have been completed,\nclinical sites have commenced patient screening and the first patient has now\nbeen dosed.\n\nAbout IHL-42X\n\nIHL-42X is Incannex’s proprietary oral fixed-dose combination of dronabinol\nand acetazolamide being developed for the treatment of obstructive sleep\napnea.\n\nThe combination is designed to target complementary physiological mechanisms\nimplicated in OSA through a single oral pharmaceutical therapy.\n\nIHL-42X has received Fast Track designation from the U.S. Food and Drug\nAdministration.\n\nAbout Incannex Healthcare Inc.\n\nIncannex Healthcare Inc. is a clinical-stage biopharmaceutical company\ndeveloping innovative combination therapies and next-generation medicines for\nconditions with significant unmet medical need. The Company’s lead programs\ninclude IHL-42X for obstructive sleep apnea, IHL-675A for rheumatoid arthritis\nand PSX-001 for generalized anxiety disorder. Incannex is committed to\nadvancing therapies that address multiple biological pathways with the goal of\nimproving patient outcomes and creating long-term shareholder value. For more\ninformation, please visit www.incannex.com.\n\nForward-Looking Statements\n\nCertain statements in this press release may constitute “forward-looking\nstatements” within the meaning of the United States Private Securities\nLitigation Reform Act of 1995, as amended to date. These statements include,\nbut are not limited to, statements relating to management’s expectations\nregarding the development, regulatory progress and commercialization of the\nCompany’s drug candidates, the potential value of the Company’s drug\ncandidates and business, and potential shareholder value. When or if used in\nthis communication, the words “may,” “could,” “should,”\n“anticipate,” “believe,” “estimate,” “expect,” “intend,”\n“plan,” “predict” and similar expressions and their variants, as they\nrelate to the Company, its operations or its management, may identify\nforward-looking statements. The forward-looking statements contained in this\npress release are based on management’s current expectations and projections\nabout future events. Nevertheless, actual results or events could differ\nmaterially from the plans, intentions, and expectations disclosed in, or\nimplied by, the forward-looking statements. These risks and uncertainties,\nmany of which are beyond our control, include: the risk that the Company’s\nestimates and current projections regarding the sufficiency of its current\ncash on hand to fund the Company’s planned operations may be incorrect and\nthe Company may use these resources faster than anticipated, risks associated\nwith the clinical development of IHL-42X and PSX-001, and other risks\ndescribed in the section entitled “Risk Factors” described in the\nCompany’s annual report on Form 10-K for the fiscal year ended June 30,\n2025, filed with the SEC on September 29, 2025, and the other reports it files\nfrom time to time, including subsequently filed annual, quarterly and current\nreports, which can be obtained on the SEC website at www.sec.gov and are made\navailable on the Company’s website upon their filing with the SEC. Readers\nare cautioned not to place undue reliance on the forward-looking statements,\nwhich speak only as of the date on which they are made and reflect\nmanagement’s current estimates, projections, expectations and beliefs. The\nCompany does not plan to update any such forward-looking statements and\nexpressly disclaims any duty to update the information contained in this press\nrelease except as required by law.\n\nInvestor & Media Contacts\n\nCORE IR\n(212) 655-0924\ninvestors@incannex.com\nmedia@incannex.com.au\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/f484ac33-560c-412b-ba64-c65ac174d6f8)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX7zV0cK","title":"Incannex Announces First Patient Dosed in DReAMzz Phase 2 Study of IHL-42X","author":"Globe Newswire","ticker":"IXHL","created":"2026-08-25T12:46:00.090Z","tickers":["IXHL"],"exchange":"NASDAQ","article_body":"NEW YORK and MELBOURNE, Australia, Aug. 25, 2026 (GLOBE NEWSWIRE) -- Incannex\nHealthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”), a\nclinical-stage biopharmaceutical company developing innovative combination\ntherapies for high-impact indications, today announced that the first patient\nhas been dosed in the DReAMzz Phase 2 dose-optimization study of IHL-42X, the\nCompany’s oral fixed-dose combination drug candidate for the treatment of\nobstructive sleep apnea (“OSA”). The milestone builds on the positive\nresults from the Phase 2 RePOSA study, in which IHL-42X demonstrated\nstatistically significant reductions in apnea-hypopnea index (“AHI”)\ncompared with placebo, with individual reductions in AHI of up to 83% observed\nand exceptional safety profile. \n\nFirst patient dosing represents another significant milestone in the continued\nadvancement of IHL-42X and follows a period of substantial clinical and\nregulatory progress for the program. Over the past year, Incannex has reported\npositive Phase 2 RePOSA results, received Fast Track designation from the U.S.\nFood and Drug Administration (“FDA”), and advanced its regulatory strategy\nfollowing engagement with the FDA. The company’s current focus, the DReAMzz\ndose-optimization study, recently commenced patient screening and has now\nprogressed to active patient dosing. All 14 DReAMzz sites now have approval\nfrom the Institutional Review Board to conduct the study.\n\nThe DReAMzz study is designed to further optimize dose selection for IHL-42X\nand strengthen the clinical and regulatory foundation for the Company’s\nplanned Phase 3 development program.\n\nJoel Latham, President and Chief Executive Officer of Incannex, said:\n\n“Dosing the first patient in DReAMzz is another important milestone for\nIHL-42X and continues a period of significant clinical and regulatory progress\nfor the program.\n\n“The momentum behind IHL-42X has continued to build over the past year. We\ndelivered positive RePOSA results, including statistically significant\nreductions in AHI and individual reductions of up to 83%, secured FDA Fast\nTrack designation, advanced our regulatory strategy and have now commenced\npatient dosing in DReAMzz.\n\n“We believe IHL-42X has the potential to reshape the treatment landscape for\nobstructive sleep apnea. OSA affects hundreds of millions of people globally,\nyet there remains a significant need for an effective oral pharmaceutical\ntreatment. The clinical results generated to date give us increasing\nconfidence in the potential of IHL-42X to address that need.\n\n“Our focus now is execution. DReAMzz is designed to optimize the treatment\nregimen and provide the data required to advance IHL-42X toward Phase 3\ndevelopment. With strong clinical data, FDA Fast Track designation and DReAMzz\nnow actively dosing patients, we believe IHL-42X is exceptionally well\npositioned as we enter this next stage of development.”\n\nFDA Fast Track Designation Supports Continued Development\n\nThe clinical progress of IHL-42X was further reinforced by the FDA granting\nFast Track designation to the program.\n\nFast Track designation is designed to facilitate the development and expedite\nthe review of therapies intended to treat serious conditions and address unmet\nmedical needs. The designation provides opportunities for more frequent\ninteractions with the FDA during development and, subject to applicable\nrequirements, may provide access to mechanisms intended to accelerate\nregulatory review.\n\nThe designation was supported by the safety, efficacy and pharmacokinetic data\ngenerated across the IHL-42X clinical development program, including the\npositive results from the Phase 2 RePOSA study.\n\nIncannex believes Fast Track designation, together with the clinical evidence\ngenerated to date, provides important regulatory support as the Company\nadvances IHL-42X through dose optimization and toward Phase 3 development.\n\nDReAMzz Phase 2 Dose-Optimization Study\n\nDReAMzz is a Phase 2 crossover dose-optimization study designed to further\ncharacterize the dose-response profile of IHL-42X and inform dose selection\nfor subsequent late-stage clinical development.\n\nThe study will evaluate objective sleep-related measures alongside\npatient-reported outcomes, providing additional data intended to refine the\nIHL-42X treatment regimen and strengthen the design of the Company’s planned\nPhase 3 program.\n\nIncannex has established a network of 14 clinical trial sites across the\nUnited States to support execution of DReAMzz. Drug product has been\nmanufactured, regulatory and operational preparations have been completed,\nclinical sites have commenced patient screening and the first patient has now\nbeen dosed.\n\nAbout IHL-42X\n\nIHL-42X is Incannex’s proprietary oral fixed-dose combination of dronabinol\nand acetazolamide being developed for the treatment of obstructive sleep\napnea.\n\nThe combination is designed to target complementary physiological mechanisms\nimplicated in OSA through a single oral pharmaceutical therapy.\n\nIHL-42X has received Fast Track designation from the U.S. Food and Drug\nAdministration.\n\nAbout Incannex Healthcare Inc.\n\nIncannex Healthcare Inc. is a clinical-stage biopharmaceutical company\ndeveloping innovative combination therapies and next-generation medicines for\nconditions with significant unmet medical need. The Company’s lead programs\ninclude IHL-42X for obstructive sleep apnea, IHL-675A for rheumatoid arthritis\nand PSX-001 for generalized anxiety disorder. Incannex is committed to\nadvancing therapies that address multiple biological pathways with the goal of\nimproving patient outcomes and creating long-term shareholder value. For more\ninformation, please visit www.incannex.com.\n\nForward-Looking Statements\n\nCertain statements in this press release may constitute “forward-looking\nstatements” within the meaning of the United States Private Securities\nLitigation Reform Act of 1995, as amended to date. These statements include,\nbut are not limited to, statements relating to management’s expectations\nregarding the development, regulatory progress and commercialization of the\nCompany’s drug candidates, the potential value of the Company’s drug\ncandidates and business, and potential shareholder value. When or if used in\nthis communication, the words “may,” “could,” “should,”\n“anticipate,” “believe,” “estimate,” “expect,” “intend,”\n“plan,” “predict” and similar expressions and their variants, as they\nrelate to the Company, its operations or its management, may identify\nforward-looking statements. The forward-looking statements contained in this\npress release are based on management’s current expectations and projections\nabout future events. Nevertheless, actual results or events could differ\nmaterially from the plans, intentions, and expectations disclosed in, or\nimplied by, the forward-looking statements. These risks and uncertainties,\nmany of which are beyond our control, include: the risk that the Company’s\nestimates and current projections regarding the sufficiency of its current\ncash on hand to fund the Company’s planned operations may be incorrect and\nthe Company may use these resources faster than anticipated, risks associated\nwith the clinical development of IHL-42X and PSX-001, and other risks\ndescribed in the section entitled “Risk Factors” described in the\nCompany’s annual report on Form 10-K for the fiscal year ended June 30,\n2025, filed with the SEC on September 29, 2025, and the other reports it files\nfrom time to time, including subsequently filed annual, quarterly and current\nreports, which can be obtained on the SEC website at www.sec.gov and are made\navailable on the Company’s website upon their filing with the SEC. Readers\nare cautioned not to place undue reliance on the forward-looking statements,\nwhich speak only as of the date on which they are made and reflect\nmanagement’s current estimates, projections, expectations and beliefs. The\nCompany does not plan to update any such forward-looking statements and\nexpressly disclaims any duty to update the information contained in this press\nrelease except as required by law.\n\nInvestor & Media Contacts\n\nCORE IR\n(212) 655-0924\ninvestors@incannex.com\nmedia@incannex.com.au\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/f484ac33-560c-412b-ba64-c65ac174d6f8)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-08-25T12:46:00.126017216Z","server_sent_at_ms":1787661960126},"received_at":"2026-08-25T12:46:00.176Z","source_url":"https://www.globenewswire.com/news-release/2026/08/25/3350465/0/en/incannex-announces-first-patient-dosed-in-dreamzz-phase-2-study-of-ihl-42x.html"},"analysis":{"id":"116021","press_release_id":"127093","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":[],"eventType":"clinical_trial","narrative":"Incannex Healthcare announced the first patient has been dosed in the DReAMzz Phase 2 dose-optimization study of IHL-42X, an oral treatment for obstructive sleep apnea.\n\nThe study builds on prior Phase 2 RePOSA results where IHL-42X showed statistically significant reductions in apnea-hypopnea index, with individual reductions of up to 83%, and leverages the program's FDA Fast Track designation.\n\nAll 14 clinical trial sites have Institutional Review Board approval, and the study aims to optimize dose selection to support the planned Phase 3 development program.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"Phase 2 dose optimization underway for lead asset IHL-42X, bolstered by Fast Track designation."},"keyFigures":{"drugName":"IHL-42X","phaseOfTrial":"Phase 2","customDimensions":{"clinical_sites":14,"max_ahi_reduction_percent":83}},"quotedText":"Dosing the first patient in DReAMzz is another important milestone for IHL-42X and continues a period of significant clinical and regulatory progress for the program.","namedEntities":{"people":[{"name":"Joel Latham","role":"President and Chief Executive Officer"}],"products":["IHL-42X","dronabinol","acetazolamide","IHL-675A","PSX-001"],"companies":[{"name":"Incannex Healthcare Inc.","ticker":"IXHL"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"},{"name":"CORE IR","relationship":"investor relations"}],"dollarAmounts":[]},"materialImpact":{"score":3,"reasoning":"First patient dosed in a Phase 2 dose-optimization study for the company's lead asset, IHL-42X. The program benefits from previously positive Phase 2 data and FDA Fast Track designation, positioning it for Phase 3."},"tickerRelevance":{"others":[],"primary":"IXHL"},"globalImportance":25,"audienceRelevance":15,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"small-cap","eventGravity":"clinical-milestone","sectorWeight":"biotech"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":3,"narrative":"Incannex Healthcare announced the first patient has been dosed in the DReAMzz Phase 2 dose-optimization study of IHL-42X, an oral treatment for obstructive sleep apnea.\n\nThe study builds on prior Phase 2 RePOSA results where IHL-42X showed statistically significant reductions in apnea-hypopnea index, with individual reductions of up to 83%, and leverages the program's FDA Fast Track designation.\n\nAll 14 clinical trial sites have Institutional Review Board approval, and the study aims to optimize dose selection to support the planned Phase 3 development program.","key_figures":{"drugName":"IHL-42X","phaseOfTrial":"Phase 2","customDimensions":{"clinical_sites":14,"max_ahi_reduction_percent":83}},"named_entities":{"people":[{"name":"Joel Latham","role":"President and Chief Executive Officer"}],"products":["IHL-42X","dronabinol","acetazolamide","IHL-675A","PSX-001"],"companies":[{"name":"Incannex Healthcare Inc.","ticker":"IXHL"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"},{"name":"CORE IR","relationship":"investor relations"}],"dollarAmounts":[]},"model_name":"glm-4.7","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-08-25T14:30:39.804Z","global_importance":25,"audience_relevance":15,"importance_components":{"tickerTier":"small-cap","eventGravity":"clinical-milestone","sectorWeight":"biotech"}},"durationMs":136137,"modelName":"glm-4.7"}}