Full Press Release Details
Incannex Healthcare Inc. Expands IHL-42X Clinical
Advisory Board with Appointments of
Four Industry and Academic Leaders to Advance Obstructive Sleep Apnea (OSA) Program
NEW YORK and MELBOURNE, Australia - June
3, 2025 - Incannex Healthcare Inc. (Nasdaq: IXHL) ("Incannex" or the "Company"), a clinical-stage biopharmaceutical
company leading the way in developing oral combination medicines, announces the recent appointment of four distinguished experts to its
IHL-42X Obstructive Sleep Apnea (OSA) Clinical Advisory Board:
"These four outstanding leaders bring incredible
depth and insight to our IHL-42X Clinical Advisory Board as we continue our work to create an unprecedented treatment to a major health
concern." said Dr. Lou Barbato, Chief Medical Officer of Incannex. "Their expertise spans academic and clinical research leadership
in sleep apnea, and we are confident the board will provide an invaluable foundation as we continue to advance IHL-42X, an Oral Once-Daily
Treatment for OSA, through late-stage development. The expansion of the clinical advisory board comes at a pivotal time for Incannex,
as we prepare to announce IHL-42X Phase 2 topline data in July 2025 and start our Phase 3 U.S. study later in the year."
Scott A. Sands, Ph.D., is an Associate Professor
of Medicine at Harvard Medical School and Director of the Sleep Apnea Translational Physiology Group in the Division of Sleep and Circadian
Disorders at Brigham and Women's Hospital. Trained in respiratory physiology and engineering, Dr. Sands has led pioneering research
in the pathophysiology of OSA, with a focus on endotypic traits and precision medicine. He is Principal Investigator on multiple NIH-
and industry-funded trials evaluating novel pharmacologic and combination therapies for OSA, including first-in-human studies. Dr. Sands
has developed innovative methodologies for phenotyping sleep apnea using clinical polysomnography and has consulted for numerous medical
device and pharmaceutical companies advancing sleep-disordered breathing therapies.
Ali Azarbarzin, Ph.D., is an Associate Professor
of Medicine at Harvard Medical School and a lead investigator at Brigham and Women's Hospital, where he directs the Sleep Apnea
Health Outcomes Group. His research centers on the physiological consequences of sleep apnea, with a focus on identifying markers of cardiovascular
and neurocognitive health. Dr. Azarbarzin is also recognized for his work in stratifying patients based on those most likely to benefit
from therapeutic intervention, supporting a precision medicine approach to OSA treatment.
Lora J. McGill, M.D., FAAN, is a board-certified
neurologist and clinical researcher based in Memphis, Tennessee. With over two decades of experience, Dr. McGill has served as an investigator
at CNS Healthcare of Memphis, where she has contributed to hundreds of industry-sponsored clinical trials focused on central nervous system
disorders. She is board-certified in both neurology and neurophysiology by the American Board of Psychiatry and Neurology and has received
multiple honors for her contributions to medical education, including the Golden Apple Award and Outstanding Lecturer recognition from
the University of Tennessee College of Medicine. She earned her medical degree from Tulane University School of Medicine in 1987 and completed
her residency and fellowship in neurophysiology at Harbor-UCLA Medical Center.
Nancy Collop, M.D. is Director of the Emory Sleep
Center and Professor of Medicine and Neurology at Emory School of Medicine. She served on the board of directors of the American Academy
of Sleep Medicine (AASM), including as President, and held board roles with the American Sleep Medicine Foundation, ACCP, Chest Foundation,
Maryland and Georgia Sleep Societies, Society for Anesthesia and Sleep Medicine, and the American Board of Sleep Medicine (ABSM), where
she also served as President. A founding member of the ABMS Sleep Medicine Examination Committee, Dr. Collop has been recognized among
the "Best Doctors in America" and named a "Distinguished Alumna for Natural Sciences" by Edinboro University.
Her awards include the Al Soffer Award for Editorial Excellence, the ACCP College Medalist award, Master Fellow distinction (2020), and
Distinguished Service Awards from the Maryland Sleep Society, ACCP, and AASM's Nathaniel Kleitman Award. From 2015 to 2024, Dr.
Collop was Editor-in-Chief of the Journal of Clinical Sleep Medicine and currently serves as Section Editor for Sleep Medicine
IHL-42X is designed to treat obstructive sleep
apnea ("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
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
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. By
targeting these core mechanisms, IHL-42X offers a differentiated approach that may benefit a wider range of patients, including the 67%
of individuals with OSA who are not classified as obese. OSA affects an estimated 1 billion people globally and approximately 30 million
people in the United States. Despite its high prevalence OSA remains significantly underdiagnosed and undertreated. IHL-42X has the potential
to address this critical gap in care and improve outcomes for millions living with this serious, chronic condition.
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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Edison Group for Incannex