PSI-GAD Generalised Anxiety Disorder
Incannex, in partnership with the Clinical Psychedelic Research Lab at Monash University, are investigating the use of psilocybin assisted psychotherapy to treat of Generalised Anxiety Disorder (GAD).
- Almost 3% of adults will experience GAD every year (10) with 32.3% having serious and 44.6% moderate impairment associated with persistent and excessive anxiety and worry about various aspects of day-to-day life (11).
- Approximately 50% of patients do not respond to first line treatment (12).
- Incannex, in partnership with the Clinical Psychedelic Research Lab at Monash University have designed a specialised psychotherapy program for use in combination with psilocybin to treat GAD patients, including those resistant to available treatments.
Global market for GAD is predicted to reach USD $ 7.5 billion by 2023(13)
- Qualified and experienced mental healthcare professionals recruited and trained by local and international experts during 2021.
- Phase 2 clinical trial protocol was submitted to the ethics review committee in August 2021. Trial expected to commence participant recruitment in early 2022.
- FDA pre-IND meeting in October 2021.
- FDA feedback will guide design of future Phase 2 and 3 studies conducted under an IND.
- HREC approval for the first Phase 2 study.
- Successful pre-IND meeting with the FDA.
Relevant ASX announcements
- 22 September 2020- IHL appoints Dr Paul Liknaitsky to Advisory Board
- 10 August 2021- HREC and FDA pre-IND request for Psilocybin Therapy
- 11 August 2021- Incannex Psychedelic Therapies Presentation
- 28 October 2021- Positive pre-IND meeting with US FDA and ethics approval to commence Phase 2a Psi-GAD clinical trial