Independent analysis has started of Incannex’s Phase 2 clinical trial to assess its psilocybin-assisted psychotherapy for treatment  of  generalised  anxiety disorder  (GAD). 

The Incannex (ASX:IHL) phase 2 PsiGAD1  clinical  trial has achieved its interim milestone of 29 patients completing primary endpoint assessments with interim analysis now underway.

Psilocybin-assisted psychotherapy has shown promise in the treatment of several mental health conditions.

PsiGAD1 was developed in collaboration with head of the clinical Psychedelic Lab at Monash University and member of IHL’s scientific advisory board Dr Paul Liknaitzky.

The study is being conducted at Monash University’s BrainPark under the leadership of Liknaitzky.

Co-investigators are Monash head of the department of psychiatry Professor Suresh Sundram and director of BrainPark Professor Murat Yücel.

Dr Liknaitzky has recruited experienced and qualified clinicians and researchers to undergo specialist training and deliver and assess the treatment.

IHL said treatment of GAD with currently accepted medications and therapies remains inadequate, with less than half of patients achieving remission.

Safety and efficacy being assessed

The trial is designed to assess the safety and efficacy of IHL’s unique psilocybin program in an active placebo-controlled study.

The 10-week treatment program includes two dosing sessions with either psilocybin or active placebo.

Safety, efficacy, quality of life and other aspects of mental and physical health are assessed.

To date, 45 participants have been enrolled in the study, with 29 participants having now completed the treatment protocol and main outcome assessment following treatment.

The interim analysis of the study data to date is being conducted by an independent Data Safety Monitoring Board (DSMB) comprising experts who are not part of the trial.

Recommendations from the DSMB will be provided in March 2023.

So far, so good

The trial continues to progress well and on time,  with  retention  of  all  participants  who  have  been  enrolled.

The  trial  team  have identified no safety concerns to date. The interim analysis will allow IHL to make key decisions on regulatory strategy and, in parallel, planning of pivotal studies, while continuing to collect data from the PsiGAD1 trial.

Patient recruitment is ongoing towards fulfilling the complete study cohort of 72 patients.

At forefront of psychedelic research and development

Liknaitzky said the  PsiGAD1  trial  is  supported  by  a  fantastic  team  of  researchers  and clinicians  and has  been  an intensive and gratifying project to lead.

“I look  forward  to  the  recommendations  of  the  Data  Safety  Monitoring  Board,  and  to continuing to progress this trial to completion.”

IHL chief  scientific  officer Dr  Mark  Bleackley said Monash University is a  major  globally recognised  and highly innovative  university.

He said Liknaitzky  and  his  team are  at  the  forefront  of psychedelic research and development.

“IHL 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,” he said.

“We  look  forward  to  providing  a  further  update  to  our  stakeholders  following the recommendations from the DSMB.”

This article was developed in collaboration with Incannex, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.