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Refer IHL site Incannex

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Independent analysis has started of Incannex’s Phase 2 clinical trial to assess its psilocybin-assisted psychotherapy for treatment of generalised anxiety disorder (GAD).

The Incannex (ASX:IHL) phase 2 PsiGAD1 clinical trial has achieved its interim milestone of 29 patients completing primary endpoint assessments with interim analysis now underway.

Psilocybin-assisted psychotherapy has shown promise in the treatment of several mental health conditions.

PsiGAD1 was developed in collaboration with head of the clinical Psychedelic Lab at Monash University and member of IHL’s scientific advisory board Dr Paul Liknaitzky.

The study is being conducted at Monash University’s BrainPark under the leadership of Liknaitzky.

Co-investigators are Monash head of the department of psychiatry Professor Suresh Sundram and director of BrainPark Professor Murat Yücel.

Dr Liknaitzky has recruited experienced and qualified clinicians and researchers to undergo specialist training and deliver and assess the treatment.

IHL said treatment of GAD with currently accepted medications and therapies remains inadequate, with less than half of patients achieving remission.

Safety and efficacy being assessed

The trial is designed to assess the safety and efficacy of IHL’s unique psilocybin program in an active placebo-controlled study.

The 10-week treatment program includes two dosing sessions with either psilocybin or active placebo.

Safety, efficacy, quality of life and other aspects of mental and physical health are assessed.