Highlights:
- 72 patients treated at purpose-built facilities within
Monash University ,Melbourne, Australia . - Topline results from the trial anticipated within current Q1 2024.
- FDA IND application is well-advanced after commencing preparations in August, 2023.
- Independent documentary covering
Monash Clinical Psychedelic Lab and PsiGAD research program to be released by SBS television network following 2 years of filming and production.
PsiGAD-1 is a randomised triple-blind active-placebo-controlled Phase 2 trial. The primary objective of the study is to determine whether a 7-week program of psilocybin-assisted psychotherapy for GAD is superior to active placebo-assisted psychotherapy in decreasing symptoms of GAD, as measured by the change in the Hamilton Anxiety Rating Scale (HAM-A) from baseline to week 11. Safety and tolerability were assessed, as well as other secondary objectives of efficacy and quality of life.
“We’re delighted to have completed all PsiGAD-1 treatments for our trial participants as we work towards finalising an FDA IND application to advance the development of this important treatment modality,” said
FDA IND Application Preparations for PsiGAD
Incannex commenced the process of drafting an FDA IND application in
In March of 2023, Incannex announced the interim analysis for the Phase 2 PsiGAD-1 clinical trial, which predicted a greater than 85% chance that the trial would show statically significant benefit for the psilocybin treatment arm versus the placebo arm at the conclusion of the trial period. An independent Data Safety Monitoring Board (DSMB) was tasked with confidentially reviewing the data for the first 37 out of 72 trial participants. At that time, the DSMB recommended no adjustments to the original study design or sample size and acknowledged no safety concerns in the operation of the trial.
Documentary on the
Commissioned by the Australian Special Broadcasting Service (SBS), a film production company has tracked the activities of the
About
Incannex is a clinical stage pharmaceutical development company that is developing unique medicinal cannabinoid 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.
Incannex has a strong patent filing strategy in place as it develops its products and therapies in conjunction with its medical and scientific advisory board and partners. The Company holds 20 granted patents and over 30 pending patent applications.
Website: www.incannex.com
Investors: investors@incannex.com.au
Forward-looking statements
This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the
Contact Information:
Mr
Chief Executive Officer, President and Director
admin@incannex.com.au
Investor Relations Contact –
jdrew-bear@edisongroup.com
Source:
2024 GlobeNewswire, Inc., source