Incannex’s Psilocybin Targets Anxiety with Positive Topline Results

Leading cannabinoid and psychedelic medicine biotechnology company, Incannex Healthcare (Nasdaq: IXHL), has achieved  positive topline results in its Phase 2 clinical trial of psilocybin in generalized anxiety disorder (GAD).

Incannex President and CEO, Joel Latham, said, “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. 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.”

Incannex is on track to submit an Investigational New Drug (IND) application with the FDA to proceed to a multi-site Phase 2b trial.

Highlights

Incannex’s trial met its primary endpoint, demonstrating a large clinical effect in the psilocybin treatment group over the placebo group.

44% of patients in the psilocybin group demonstrated at least 50% reduction in anxiety score and 27% of patients showed disease remission, a remission rate more than 5 times higher than that of therapy with placebo.

Psilocybin within the context of PsiGAD psychotherapy was observed to be well-tolerated, with only mild and moderate adverse events reported.

GAD is characterized by excessive anxiety and worry that occurs more days than not for at least 6 months. 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.

About Incannex Healthcare Inc.

Incannex is a clinical stage pharmaceutical development company that is developing unique medicinal cannabis pharmaceutical products and psychedelic medicine therapies for the treatment of obstructive sleep apnoea (OSA), traumatic brain injury (TBI) and concussion, lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis, inflammatory bowel disease, anxiety disorders, addiction disorders, and pain, among other indications.