An interim review into the proprietary Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL) PsiGAD psilocybin-assisted psychotherapy program has revealed the study has an 85% probability of demonstrating a “statistically significant” benefit versus placebo for those participants who completed the treatment.
This interim review assessed results from the first 29 participants to complete the treatment protocol and included conditional power analysis using the interim data to model and project total study data.
IHL’s conclusion was based on strong results to date, specifically analysing a reduction in Hamilton Anxiety Rating Scale (HAM-A) score at 11 weeks relative to baseline, which is the primary endpoint in the trial.
Psilocybin-assisted psychotherapy uses psilocybin (the active compound in hallucinogenic mushrooms or magic mushrooms) to improve the effectiveness of psychotherapy for mental health indications like Generalised Anxiety Disorder (GAD).
The treatment involves two administrations of psilocybin in conjunction with psychotherapy in a controlled clinical setting as part of a 10-week course of specialised treatment.
Modelling was completed internally by Incannex, without verification from DMSB, as an interim measure.
Potential to transform anxiety therapies
“The results from the interim analysis of Incannex’s Phase 2 clinical trial provide us with encouragement that our PsiGAD psilocybin-assisted psychotherapy treatment protocol has the potential to transform the lives of people suffering from anxiety," Incannex Healthcare CEO and managing director Joel Latham said.
"I believe IHL is leading the way in research on novel treatments for this debilitating indication.
“Even though the results must remain blinded until the conclusion of the trial, the confidential review has given us the confidence to commence manufacture of our own psilocybin drug product with the appointment of Catalent, progress planning of our pivotal trials and commence drafting our FDA IND application for the PsiGAD treatment program.
“The Clinical Psychedelic Lab at Monash University has overseen training of 14 psychotherapists to work on the phase 2 trial, demonstrating that this transformational treatment is scalable to many therapists and patients throughout the world.”
Generalised anxiety disorder, the main focus of IHL’s trial, affects millions of people across the globe each year.
GAD is characterised by excessive anxiety and worry that occurs more days than not for at least six months and is not restricted to any particular environmental circumstances.
Symptoms include feelings of persistent and excessive worry, nervousness, restlessness, difficulty concentrating and a range of physical (somatic) manifestations.
People with GAD find it difficult to control their anxiety and stress levels, which can cause significant emotional distress as well as impairment in social, occupational or educational environments.