Incannex Healthcare Concludes Phase 2 Trial of Psilocybin Therapy for Anxiety Disorder, Awaiting FDA IND Application


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LOS ANGELES- Incannex Healthcare Inc., a pharmaceutical company in the development of medicinal cannabinoid and psychedelic medicine therapies, has recently completed a significant milestone in its PsiGAD-1 clinical trial. This Phase 2 study, focused on evaluating the company’s proprietary psilocybin treatment for generalized anxiety disorder (GAD), successfully completed dosing and treatment protocols for all 72 participants.

Conducted at Monash University in Melbourne, Australia, the PsiGAD-1 trial is a randomized, triple-blind, active-placebo-controlled study. Its primary goal is to determine the efficacy of a 7-week psilocybin-assisted psychotherapy program in reducing GAD symptoms, measured by changes in the Hamilton Anxiety Rating Scale (HAM-A). The trial’s comprehensive approach included safety and tolerability assessments, along with evaluating secondary objectives concerning efficacy and quality of life.

Joel Latham, CEO and Director of Incannex, expressed satisfaction with the trial’s progress. The study represents a response to the urgent need for effective treatments for GAD, a condition characterized by persistent and excessive worry affecting millions worldwide. Monash University’s involvement in this extensive clinical trial included screening 975 individuals and conducting 174 psychedelic dosing sessions, making it one of the largest trials of its kind.

In preparation for the topline results from PsiGAD-1, expected within the current Q1 2024, Incannex has advanced its efforts towards an FDA Investigational New Drug (IND) application. The process, initiated in August 2023, aims to propel the development of this novel treatment approach.

The interim analysis of the PsiGAD-1 trial, announced in March 2023, indicated a high probability of statistically significant benefits from the psilocybin treatment over the placebo. An independent Data Safety Monitoring Board (DSMB) reviewed the data for the first 37 participants, recommending no modifications to the study design or sample size and confirming no safety concerns.

Further raising public awareness and understanding of psychedelic therapies, a documentary titled “Psychedelics: Stepping into the Unknown” is set to be released in late February 2024. Commissioned by the Australian Special Broadcasting Service (SBS) and produced over two years, this documentary highlights the work of the Monash Clinical Psychedelic Lab, a key partner in Incannex’s research program. It promises to offer insights into the field of mental health and the intricate processes involved in delivering safe psychedelic therapies.

As Incannex Healthcare Inc. awaits the final results of the PsiGAD-1 trial and progresses with its FDA IND application, the company stands at the forefront of developing groundbreaking treatments for anxiety disorders. Their work not only advances the medical field but also contributes significantly to the conversation around mental health treatment options.


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