- Incannex Healthcare (IHL) achieves an interim milestone in its clinical trial to treat generalised anxiety disorder
- Twenty-nine patients of the 45 enrolled have now completed primary endpoint assessments as part of the company’s psilocybin-assisted psychotherapy study
- An interim analysis of the study data has now begun and is being carried out by an independent data safety monitoring board (DSMB)
- IHL is trading 2.63 per cent higher at 19.5 cents at 11:30 am AEDT
Incannex Healthcare (IHL) has reached an interim milestone in its PsiGAD1 clinical trial, which tests the company’s psilocybin-assisted psychotherapy for the treatment of generalised anxiety disorder (GAD).
Of the 45 patients enrolled in the study, 29 have now completed primary endpoint assessments.
The study assesses the safety and efficacy of the company’s psilocybin program in an active, placebo-controlled study, carried out by Dr Paul Liknaitzky, the Head of the Clinical Psychedelic Lab at Monash University within the university’s BrainPark. He has been joined by investigators Professor Suresh Sandram, Head of Department of Psychiatry at Monash, and Director of BrainPark, Professor Murat Yücel.
“Monash University is a major globally recognised and highly innovative university,” Incannex Chief Scientific Officer Dr Mark Bleackley commented.
“Incannex continues to benefit from the academic rigour that, Monash University and Dr Liknaitzky bring to the development of this therapy, which should assist our ambitions to be amongst the first companies in the world to provide a proprietary psychedelic therapy to the public.”
The ten-week treatment program looks at the safety, efficacy, quality of life, and other aspects of mental and physical health.
With the milestone now reached, an interim analysis of the study data to date has commenced and is being carried out by an independent data safety monitoring board (DSMB).
Incannex said its psilocybin-assisted psychotherapy showed promise in the treatment of several mental health conditions, however, the treatment of GAD with currently accepted medications and therapies saw only half of the patients achieving remission.
Incannex expects recommendations from the analysis to be provided in March 2023, with the trial set to continue.
IHL was trading 2.63 per cent higher at 19.5 cents at 11:30 am AEDT.