Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL) has achieved an interim milestone for the PsiGAD1 clinical trial assessing the effect of psilocybin-assisted psychotherapy for the treatment of generalised anxiety disorder (GAD), having completed primary endpoint assessments for 29 patients.
The company is now engaging a Data Safety Monitoring Board (DSMB) of experts not related to the trial to review and analyse the interim data from PsiGAD1, a critical element of maintaining the integrity of the clinical trial.
IHL expects to receive the recommendations from the DSMB in March this year, while the trial continues in the meantime, on time and with full participant retention.
“The PsiGAD1 trial is supported by a fantastic team of researchers and clinicians and has been an intensive and gratifying project to lead,” said principal investigator on the trial, Dr Paul Liknaitzky.
“I look forward to the recommendations of the Data Safety Monitoring Board, and to continuing to progress this trial to completion.”
Addressing a lack of GAD therapies
Generalised Anxiety Disorder is a complex disorder with limited treatment options, as many patients are unable to achieve remission even with medication and therapy.
Psilocybin-assisted psychotherapy has shown promise in the treatment of several mental health conditions, including post-traumatic stress disorder (PTSD), GAD and Major Depressive Disorder (MDD).
PsiGAD1 was developed in collaboration with Dr Liknaitzky, head of the Clinical Psychedelic Lab at Monash University and a member of the Incannex Scientific Advisory Board.
The trial is designed to assess the safety and efficacy of IHL’s 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.
“Monash University is a major globally recognised and highly innovative university. Dr Liknaitzky and his team are at the forefront of psychedelic research and development,” Incannex Healthcare chief scientific officer Dr Mark Bleackley said.
“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.
“We look forward to providing a further update to our stakeholders following the recommendations from the DSMB.”