Positive results announced in phase 2 trial of psilocybin for generalized anxiety disorder
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Key takeaways:
- PsiGAD psilocybin-assisted therapy demonstrated a statistically significant reduction from baseline in anxiety scores.
- Psilocybin was well-tolerated, with only mild and moderate adverse events reported.
Incannex Healthcare has announced positive topline results from its phase 2 PsiGAD1 clinical trial of psilocybin for generalized anxiety disorder, reporting statistically significant improvement in anxiety scores compared with placebo.
According to a company press release, the trial met its primary endpoint, with PsiGAD psilocybin-assisted therapy demonstrating a statistically significant reduction of 12.8 points from baseline on the Hamilton Anxiety Rating Scale (HAM-A), a decrease of 9.2 points over the placebo group.
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Among patients in the psilocybin group, 44% showed at least 50% reduction in anxiety score from baseline, and 27% achieved full disease remission.
“This is the first time psilocybin has been investigated for treatment of generalized anxiety disorder, and the reduction in HAM-A scores we have observed are far greater than those reported from trials on established medicines for treatment of anxiety,” Joel Latham, president and CEO at Incannex Healthcare, said in the release.
Additionally, psilocybin was well-tolerated, the company stated, with only mild and moderate adverse events reported.
“The safety and efficacy results from PsiGAD1 implore us to continue the development of PsiGAD through large-scale, well-controlled trials, because this treatment method has the potential to improve the quality of life for millions of people suffering from generalized anxiety disorder,” Latham said in the release.
The company plans to submit an investigational new drug application with the FDA to proceed to a multicenter, phase 2b clinical trial.