Full Press Release Details
Incannex Healthcare Officially Commences DReAMzz
Clinical Study for IHL-42X in Obstructive Sleep Apnea
Major operational milestone achieved as Incannex
advances late-stage development of IHL-42X, with all clinical sites identified and trial infrastructure activated
MELBOURNE, Australia and NEW YORK, May 14, 2026 (GLOBE NEWSWIRE)
- Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage biopharmaceutical company advancing innovative combination therapies
for high-impact indications, today announced the official commencement of its DReAMzz clinical study evaluating IHL-42X for the treatment
of obstructive sleep apnea (OSA).
The commencement of DReAMzz represents a major operational and strategic
milestone for the Company as it advances IHL-42X toward late-stage clinical development and potential registration pathways. The Company
has now completed extensive site feasibility assessments, identified all 14 clinical trial sites, completed manufacturing of IHL-42X drug
product, secured all required import and export permits, and onboarded its newly appointed global distribution partner in preparation
for site activation and patient dosing.
The DReAMzz study is designed as a crossover dose optimization study
intended to further refine the dosing profile of IHL-42X and strengthen the design of the planned Phase III development program. The study
is expected to generate additional data evaluating the relationship between dose optimization, objective sleep metrics, and patient-reported
outcomes, which are becoming increasingly important in both regulatory review and commercial positioning within the OSA market.
Importantly, the DReAMzz program is designed to further optimize and
de-risk the Phase III pathway following the positive Phase II RePOSA clinical trial, where IHL-42X demonstrated statistically significant
and clinically meaningful reductions in apnea-hypopnea index (AHI), alongside improvements in oxygenation, sleep quality, fatigue-related
outcomes and broader patient-reported measures. Incannex believes the DReAMMZ study has the potential to provide the Company with a more
efficient pathway toward potential registration by optimizing the Phase III design prior to commencement, while also supporting more disciplined
and effective capital deployment.
In recognition of the significant unmet need in obstructive sleep apnea
and the encouraging clinical profile demonstrated by IHL-42X to date, the U.S. Food and Drug Administration (FDA) previously granted IHL-42X
Fast Track designation for the treatment of OSA. The designation is intended to facilitate the development and expedite the review of
therapies targeting serious conditions where there is the potential to address unmet medical need.
The Company believes the combination of strong Phase II efficacy data,
encouraging patient-reported outcomes, operational advancement through DReAMzz and FDA Fast Track designation positions IHL-42X as one
of the leading oral pharmacotherapy programs currently in development for obstructive sleep apnea.
"This is a significant milestone for Incannex and reflects the
substantial operational progress made by the team over recent months," said Dr. Lou Barbato, Chief Medical Officer of Incannex Healthcare
Inc. "We have now transitioned from planning into active execution of the DReAMzz study, with critical infrastructure across manufacturing,
logistics, clinical sites and trial operations established and ready to support the next stage of development."
"Importantly, this study is designed to further optimize and
de-risk the Phase III pathway for IHL-42X following the highly encouraging RePOSA data. We believe IHL-42X has the potential to become
a transformative oral therapy in obstructive sleep apnea, a market where there remains a substantial unmet need despite the size and maturity
of existing treatment approaches. The commencement of DReAMzz represents another major step toward realizing that opportunity."
The Company confirmed that all 14 sites selected for the DReAMzz study
have been identified following an extensive feasibility review process focused on sleep medicine expertise, patient recruitment capabilities,
operational execution, and experience conducting complex overnight sleep studies. Site contracting activities are now underway, with contracts
in place with high recruiting sites from RePOSA, enabling activation activities to progress efficiently.
In parallel, Incannex has completed manufacturing activities for IHL-42X
clinical trial supply. Required import and export permits have also been secured, allowing the Company to efficiently distribute clinical
material as sites become activated. A newly appointed distribution partner has now been fully onboarded to support supply chain management
and study logistics.
The DReAMzz study forms part of Incannex's broader strategy to
position IHL-42X as a differentiated, late-stage asset targeting one of the largest and most underserved markets in sleep medicine. Obstructive
sleep apnea affects hundreds of millions of people globally, with current standards of care limited by significant adherence and tolerability
challenges. Incannex believes IHL-42X's multi-mechanistic approach has the potential to address important gaps in existing treatment
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.
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progress and commercialization of the Company's drug candidates, including IHL-42X, expectations regarding use of the Company's
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current cash on hand to fund the Company's planned operations may be incorrect and the Company may use these resources faster than
anticipated, and other risks described in the section entitled "Risk Factors" described in the prospectus supplement and in
the Company's annual report on Form 10-K for the fiscal year ended June 30, 2025, filed with the SEC on September 29, 2025, and
the other reports it files from time to time, including subsequently filed annual, quarterly and current reports, which can be obtained
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