General Anxiety Disorder

PSI-GAD General Anxiety Disorder (GAD)

About

Incannex are developing a psilocybin assisted psychotherapy system for treatment of Generalised Anxiety Disorder (GAD).

Program Overview

  • 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 have designed a specialised psychotherapy program for use in combination with psilocybin to treat GAD patients, including those resistant to available treatments.

 

10 www.beyondblue.org.au/the-facts/anxiety/types-of-anxiety/gad

11 www.nimh.nih.gov/health/statistics/generalized-anxiety-disorder

12 www.ncbi.nlm.nih.gov/pmc/articles/PMC7653736/

Addressable Market

Global market for GAD is predicted to reach USD $ 7.5 billion by 2023(13)

 

13 www.prnewswire.com/news-releases/global-generalized-anxiety-disorder-market-is-estimated-to-grow-at-25-cagr-to-reach-75-billion-by-2023-679279763.html

Development

  • Phase 2 clinical trial protocol was submitted to the ethics review committee in August 2021. Trial expected to commence late 2021/early 2022.
  • FDA pre-IND meeting in October 2021, feedback expected late 2021.
  • FDA feedback will guide design of future Phase 2 and 3 studies conducted under an IND.
  • HREC approval for the Phase 2 study.
  • Successful pre-IND meeting with the FDA.