Incannex Healthcare Releases Phase 2 Results For IHL-42x, Showing Up To An 83% Reduction In Sleep Apnea Severity With Strong Safety And Patient-Reported Outcomes, And For PSX-001, Demonstrating Statistically Significant And Durable Improvements In Generalized Anxiety Disorder With Excellent Tolerability

Author: Benzinga Newsdesk | October 30, 2025 07:04am

MELBOURNE, Australia and NEW YORK, Oct. 30, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (NASDAQ:IXHL)("Incannex" or the "Company"), a clinical-stage pharmaceutical company developing innovative combination therapies for high-impact medical conditions, provides a shareholder update highlighting recent progress across its clinical and corporate initiatives and outlining key priorities for the remainder of 2025.

Recent Highlights

• IHL-42X (OSA) Phase 2 – Statistically significant efficacy, outstanding patient-reported outcomes, and strong safety profile – Incannex reported Phase 2 data for IHL-42X demonstrating statistically significant and clinically meaningful reductions in Apnea-Hypopnea Index (AHI) of up to 83% from baseline, confirming the potential of IHL-42X to meaningfully improve disease severity in obstructive sleep apnea (OSA). The study also showed significant improvements across multiple sleep-quality and fatigue instruments, accompanied by an outstanding safety and tolerability profile.
  
  Structured exit interviews reinforced the objective findings, with 57.6% of participants across the study, increasing to 78.6% of those assigned to the low dose group, reporting perceived improvement in their OSA. Of participants reporting an improvement in their OSA, 86.4% described the benefit as meaningful to daily life. Together, we believe these results demonstrate a potential consistent and meaningful treatment effect across both quantitative and qualitative measures
• PSX-001 (psilocybin-assisted psychotherapy for Generalized Anxiety Disorder – GAD) Phase 2: Positive Topline Results – The Company reported statistically significant and clinically meaningful improvements versus placebo across the primary endpoint (HAM-A) and multiple secondary measures (GAD-7, SDS, PHQ-9, and PWI), demonstrating both the robust efficacy and breadth of therapeutic impact of PSX-001. Participants experienced sustained symptom relief over 11 weeks, highlighting the durability of the treatment effect. The study also confirmed excellent tolerability and safety, with no serious adverse events reported. We believe these results underscore PSX-001's potential to set a new standard in the treatment of anxiety disorders, addressing a large unmet medical need with an innovative, well-tolerated therapy that could transform the lives of millions of patients worldwide.
• At-The-Market (ATM) Offering – The Company has not utilized its ATM facility since August 28, 2025, with the total number of shares on issue remaining unchanged at 347,705,507, as reported in the Company's Form 10-K. We believe this highlights the Company's strong balance sheet and capital efficiency, enabling the continued advancement of its lead clinical programs without the current need for further equity dilution. The decision reflects management's strategic discipline and unwavering focus on its goal of long-term shareholder value creation, reinforcing the strength of the Company's financial position and its confidence in near-term growth catalysts.
  
   

Posted In: IXHL