- Incannex Healthcare Limited IXHL announced interim review results from its ongoing Phase 2 clinical trial of the psilocybin-assisted psychotherapy program for Generalised Anxiety Disorder (GAD), known as PsiGAD.
- IHL has reviewed the interim data from the first 29 participants to complete the treatment protocol and completed a conditional power analysis using the interim data to model and project total study data.
- The company found a high probability (greater than 85% - alpha error 0.05 or 95% confidence level) that the study will show a statistically significant benefit for the psilocybin treatment arm over the placebo treatment arm.
- The primary endpoint was a reduction in Hamilton Anxiety Rating Scale (HAM-A) score at 11 weeks relative to baseline.
- A review was also conducted by an independent DSMB, which reviewed the available data from the first 37 out of 72 participants.
- The trial continues to progress well and on time, with the retention of all participants who have been enrolled. The trial team has identified no safety concerns to date, and the DSMB has recommended that the trial continues without changes.
- Treatment of all 72 trial participants is anticipated to be completed in the fourth quarter of 2023.
- Price Action: IXHL shares are up 14.66% at $2.66 on the last check Wednesday.
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