Incannex announces positive topline results from phase 2 Psi-GAD1 clinical trial of psilocybin in generalised anxiety disorder

I an interestingly parallel study for psilocybin-assisted therapy for GAD, the pharma company Incannex announced: "Highlights:  PsiGAD1 trial achieves primary endpoint; PsiGAD psilocybin-assisted therapy demonstrated a statistically significant HAM-A reduction of 12.8 points from baseline, representing a 9.2-point improvement over psychotherapy with placebo (p <0.0001), exceeding the company’s expectations.  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.  Newly developed and formulated PSX-001 psilocybin drug product has been finalised - cGMP manufacture for clinical trial supply underway.  Incannex to submit an Investigational New Drug (IND) application with U.S. Food and Drug Administration (FDA) to proceed to a multi-site Phase 2B trial … “We are thrilled with the results from our initial PsiGAD trial,” said President and CEO Joel Latham. “This is the first time psilocybin has been investigated for treatment of generalised anxiety disorder, and the reduction in HAM-A scores we have observed are far greater those reported from trials on established medicines for treatment of anxiety. The improvement in anxiety scores in PsiGAD1 are of a similar magnitude to the change seen in studies investigating psilocybin for treatment of depression disorders … Incannex have designed the follow-up Phase 2B clinical trial, PsiGAD2, with the assistance of Clerkenwell Health, a UK based contract research organisation specialising in psychiatry and CNS treatments. This trial will be conducted at multiple sites in the United States (US) and United Kingdom (UK) … Incannex is continuing to work with Clerkenwell Health to select trial sites and prepare the relevant regulatory documents for submission to the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK … Generalised Anxiety Disorder (GAD) is characterised by excessive anxiety and worry that occurs more days than not for at least 6 months and is not restricted to any particular environmental circumstances. Symptoms are variable, including 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. GAD is a relatively common disorder (about 6-9% lifetime prevalence, and about 3% 12-month prevalence in countries like Australia and the United States). As with other mood disorders, successful treatment of GAD remains inadequate, with less than half of patients achieving remission following evidence-based treatment, alongside high relapse rates, and substantial treatment side-effects or cost." [See too https://tinyurl.com/muxepnan for linked article ‘Psychedelics at Monash' (Melbourne)].

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