Full Press Release Details
Incannex Healthcare Inc. Provides Clinical Program Update on IHL-42X,
an Oral Once-Daily Treatment for Obstructive Sleep Apnea (OSA)
NEW YORK and MELBOURNE, Australia, May 14, 2025
(GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex), a clinical-stage biopharmaceutical company leading the way in
developing oral combination medicines, today provided an update on its obstructive sleep apnea (OSA) clinical program and outlined key
upcoming catalysts in the development of IHL-42X.
"We are pleased with the rapid completion
of patient dosing in the Phase 2 study," said Joel Latham, President and CEO of Incannex. "The IHL-42X program continues its
strong momentum as we prepare for data analysis and advance toward our end-of-Phase 2 meeting with the FDA. The third quarter of 2025
represents a pivotal period of progress for the company. With the successful completion of Phase 2 enrollment, encouraging pharmacokinetic
and safety data, and expanded clinical advisory expertise, we are well-positioned to advance IHL-42X as a potential first-in-class oral
treatment for millions of patients living with OSA."
"Obstructive sleep apnea affects millions
globally and is closely linked to other serious conditions including obesity, cardiovascular disease, and metabolic dysfunction. Incannex
believes that IHL-42X will offer a significant breakthrough in a therapeutic area long dominated by mechanical interventions like CPAP
devices. We believe IHL-42X is uniquely positioned to address one of the most prevalent sleep disorders worldwide."
have also engaged in several promising commercial discussions regarding IHL-42X and look forward to continuing these as we work to deliver
maximum value for our shareholders. The enthusiasm shown by U.S. clinical sites and trial participants has further reinforced our decision
to conduct Phase 3 exclusively in the United States, ensuring a focused and efficient development pathway."
Clinical and Program Updates:
Unlike weight loss therapies, IHL-42X is uniquely
engineered to target two key physiological pathways, intermittent hypoxia (IH) and hypercapnia, that underlie the pathology of OSA. This
differentiated mechanism positions IHL-42X as a potential treatment option for a broader OSA population, including the 67% of patients
who are not obese, as reported in a recent publication examining the link between obesity and OSA1.
In a previously completed Phase 2 clinical trial
conducted in Australia, IHL-42X demonstrated clinically meaningful reductions in the Apnea-Hypopnea Index (AHI) across all dose levels,
with the lowest dose reducing AHI by an average of 51% from baseline. A subsequent peer-reviewed publication analyzing this trial, further
clarified IHL-42X's mechanism of action and the treatment was shown to improve OSA severity by lowering loop gain and enhancing
upper airway stability 2.
Importantly, the analysis also found that IHL-42X
significantly reduced hypoxic burden (HB)-a more comprehensive and clinically relevant measure of OSA severity than AHI alone, as
it captures both the depth and duration of oxygen desaturation events3. Elevated HB has been strongly correlated with cardiovascular
morbidity and all-cause mortality, reinforcing the therapeutic potential of IHL-42X as a once-daily, oral treatment capable of addressing
a critical unmet need in sleep medicine.
For more information
on the IHL-42X clinical program, please visit www.incannex.com.
IHL-42X is designed to treat OSA by targeting
its underlying pathophysiology. An oral fixed-dose combination of dronabinol and acetazolamide, IHL-42X is currently advancing through
the RePOSA Phase 2/3 clinical trial, which is expected to enroll more than 560 patients at sites worldwide.
Designed to act synergistically, IHL-42X uniquely
targets two 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 na ve to positive airway pressure devices, including CPAP, with the Phase 2
portion conducted in the United States. A topline readout from the U.S. Phase 2 portion is anticipated in July 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 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
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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
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Incannex's ability to raise capital to fund continuing operations and to complete capital raising transactions; the impact of any infringement
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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
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reports filed with the U.S. Securities and Exchange Commission (SEC) including its annual report on Form 10-K for the fiscal year ended
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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.
Edison Group for Incannex