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Incannex Healthcare Expands Clinical Advisory Board to Support Obstructive Sleep Apnea Program with Appointment of Dr. Charlene E. Gamaldo
Globenewswire· 2025-07-25 11:30
Core Insights - Incannex Healthcare Inc. has appointed Dr. Charlene E. Gamaldo to its IHL-42X Obstructive Sleep Apnea Clinical Advisory Board, enhancing the company's expertise in sleep medicine [1][2] - The Phase 2 data readout for IHL-42X is expected next week, indicating the company's confidence in the asset and commitment to its development [2] - IHL-42X is an oral fixed-dose combination of dronabinol and acetazolamide, currently in the RePOSA Phase 2/3 clinical trial, targeting obstructive sleep apnea by addressing its underlying pathophysiology [6][9] Company Overview - Incannex is focused on developing combination medicines for chronic conditions, including obstructive sleep apnea, rheumatoid arthritis, and generalized anxiety disorder [9][10] - The company is advancing three clinical-stage product candidates, with IHL-42X being the lead program designed to target the mechanisms of obstructive sleep apnea [9][10] - IHL-42X aims to benefit a broader range of patients, including the 67% of individuals with obstructive sleep apnea who are not classified as obese, addressing a significant gap in care [8] Clinical Development - The RePOSA Phase 2/3 clinical trial for IHL-42X is expected to enroll over 560 patients globally, with the Phase 2 portion conducted in the United States [6][7] - A topline readout from the U.S. Phase 2 portion is anticipated in July 2025, which will provide critical data on the efficacy of IHL-42X [7][8] - IHL-42X targets two key physiological pathways associated with obstructive sleep apnea, differentiating it from traditional weight loss therapies [8]
Incannex Healthcare Inc. Reports Fiscal Third Quarter 2025 Financial Results and Business Updates
GlobeNewswire News Room· 2025-05-15 12:00
Core Viewpoint - Incannex Healthcare Inc. is making significant progress in its IHL-42X development program for treating obstructive sleep apnea (OSA), with key milestones expected in the near future [2]. Operational Highlights - The company secured $12.5 million in private placement funding to support the ongoing IHL-42X Phase 2/3 clinical program [7]. - An OSA Clinical Advisory Board was formed, with Dr. Alison Wimms appointed to enhance collaboration and clinical development efforts [7]. - More than 120 patients have been dosed across 11 clinical trial sites in the Phase 2 portion of the RePOSA study [7]. Clinical Highlights - IHL-42X is an oral fixed-dose combination of dronabinol and acetazolamide, currently in the RePOSA Phase 2/3 clinical trial, which aims to enroll over 560 patients globally [6]. - The trial is evaluating two doses of IHL-42X compared to placebo over a four-week treatment period, with topline data expected in July 2025 [7][8]. - Positive topline results from a pharmacokinetics and safety study confirmed the bioavailability of both active components in IHL-42X [7]. Financial Results - General and Administrative (G&A) expenses for the three months ended March 31, 2025, were $2.27 million, down from $4.14 million in the same period of 2024 [7]. - Research and Development (R&D) expenses for the same period totaled $2.74 million, compared to $3.28 million in 2024 [7]. - The net loss for the three-month period ended March 31, 2025, was $3.97 million, a decrease from $6.03 million in the prior year [7].