Incannex’s interim data predicts a statistically significant benefit for psilocybin therapy over placebo when treating anxiety, FDA IND application now in sight

Even though specific data from the PsiGAD trial cannot yet be released until the trial is completed, positive interim results of the Phase-2 clinical trial has given Incannex the encouragement to commence drafting an FDA IND application

Incannex Healthcare (ASX:IHL) says that an interim review of its clinical trial data has indicated no safety concerns, and even projected a statistically significant benefit for the psilocybin treatment arm versus the placebo treatment arm in those patients who have completed the treatment.

The pharmaceutical cannabinoid and psychedelics company is currently undergoing a Phase-2 clinical trial for its proprietary psilocybin-assisted psychotherapy program for Generalised Anxiety Disorder (GAD), in a clinical trial program also known as “PsiGAD”.

From the interim data so far, IHL found there is a high probability (greater than 85% with 95% confidence level) that the study, when completed, will show a statistically significant benefit for the psilocybin treatment arm over the placebo treatment arm.

This projection is made by assuming the effect size observed in the current 29 participants will be representative of the effect size through the remaining 43 participants of the 72 person trial.

First announced in December 2020, this Phase-2 study is a world-first clinical trial conducted through a partnership between Incannex and Monash University, and is led by Dr Paul Liknaitzky, a Research Fellow at the University.

“The results from the interim analysis of our 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,” said Incannex CEO, Joel Latham.

“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.”

A huge market opportunity to treat GAD

GAD affects millions of people across the globe each year, and is characterised by excessive anxiety and worry that occurs more days than not for at least 6 months.

The disease is not restricted to any particular environmental circumstances, and symptoms include feelings of persistent and excessive worry, nervousness, restlessness, difficulty concentrating, and a range of somatic manifestations.

People with GAD find it difficult to control their worry, which may cause significant distress and impairment in social, occupational, or other areas of functioning.

And as with other mood disorders, current treatments of GAD remain inadequate, with less than half of patients achieving remission following evidence-based treatment, alongside high relapse rates, and substantial treatment side-effects or cost.

Incannex’ psilocybin-assisted psychotherapy aims to address this market gap by using psilocybin to improve the effectiveness of psychotherapy for GAD sufferers.

The treatment in the Phase-2 trial involves two administrations of psilocybin in conjunction with psychotherapy, in a controlled clinical setting as part of a 10-week course of specialised treatment.

Commencement of FDA application

The trial employs a team of experienced and qualified clinicians and researchers who undergo specialist training before they deliver and assess the treatment.

To date, over 45 participants have been enrolled in the study, with 29 participants having now completed the treatment protocol and main outcome assessment following treatment.

Treatment of all 72 trial participants is anticipated to be completed in the fourth quarter of 2023.

The end point used in the study was a reduction in Hamilton Anxiety Rating Scale (HAM-A) score at 11 weeks relative to baseline, which is the primary endpoint in the trial.

The HAM-A was one of the first rating scales developed to measure the severity of anxiety symptoms, and is still widely used today in both clinical and research settings.

This article was developed in collaboration with Incannex Healthcare, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.