- Incannex Healthcare (IHL) projects its clinical trial will show a “statistically significant benefit” of psilocybin to treat general anxiety disorder
- Following an interim review of study data, IHL predicts there is an 85 per cent chance the trial will show a benefit for psilocybin compared to a placebo
- The company’s foretelling assumes the effect size observed in the interim analysis for 29 participants is representative of the remaining 43 participants
- The trial team, and an independent data safety monitoring board, have identified no safety concerns and no changes to the study design have been recommended
- IHL shares are down 6.9 per cent trading at 13.5 cents at 3:40 pm AEDT
Incannex Healthcare (IHL) has projected its clinical trial will show a “statistically significant” benefit of psilocybin to treat general anxiety disorder (GAD).
The company’s projection follows an interim review of the conduct, safety and data from its ongoing phase two clinical trial assessing its proprietary psilocybin-assisted psychotherapy program for GAD, known as ‘PsiGAD’.
After reviewing data from the first 29 participants, Incannex said there was a greater than 85 per cent chance the study would conclude with a statistically significant benefit for the psilocybin treatment over a placebo.
This view is based on the company’s assumption that the effect size observed in the interim analysis is representative of the effect size for the remaining 43 participants.
Incannex CEO and Managing Director Joel Latham said the results were encouraging.
“Even though the results must remain blinded until the conclusion of the trial, the confidential review has given us the confidence to commence the 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.”
A review was also conducted by an independent data safety monitoring board that identified no safety concerns so far and recommended the trial continue without changes.
Treatment of all 72 trial participants is expected to be completed in the fourth quarter of 2023.
IHL shares were down 6.9 per cent and trading at 13.5 cents at 3:40 pm AEDT.