The company’s latest update clearly illustrates the rigorous testing approach adopted by IHL’s world-leading research team at Monash University.
Clinical-stage biopharmaceutical company Incannex Healthcare (ASX:IHL) continues to take a diligent approach in the development of its unique psilocybin therapy for the treatment of generalised anxiety disorder (GAD).
Together with its leading research partners at Monash University, the company has laid out the blueprint for a two-stage Phase 2 trial process, set to commence in the second half of this year.
In its latest update, IHL announced this morning it has now completed a Human Research Ethics Committee (‘HREC’) submission for the Phase 2a Psi-GAD component of the study,
The group has also engaged regulatory specialists Camargo Pharmaceuticals in the construction of a comprehensive information package, which it has now submitted for the purpose of requesting a pre-IND meeting with the US Food & Drug Administration (FDA).
Both updates follow an extensive period of development work in the design of the clinical trial process.
Led by principal investigator Dr Paul Liknaitzky, who heads the Clinical Psychedelic Research Lab at Monash University, the trial methodology has been developed by a team of local and international experts with extensive experience in psychedelic-assisted therapies.
And with its detailed groundwork now complete, IHL is planning to commence the Phase 2a trial in the second half of this year.
Shares in the company rose again in morning trade following the announcement, up almost 4% to 27.5c.
Generalised anxiety disorder is defined as anxiety that occurs over an extended period with specific environment catalysts.
Existing treatments such as Cognitive Behavioural Therapy and antidepressants have so far had limited success in treating the problem, IHL said.
GAD symptoms are often more severe than other anxiety diagnoses. It affects between 7-9 million US citizens each year and around 1 million Australians.
Clinical trial blueprint
The innovative Phase 2a has been designed to test the application of psilocybin in a combination therapy to patients with GAD.
“The trial will be conducted at BrainPark, a state-of-the-art neuroscience research platform at Monash University’s Turner Institute for Brain and Mental Health,” IHL said.
The Phase 2a study will be a randomised triple-blind, active-placebo-controlled trial, treating 72 patients over a 10-week period.
Patients will receive doses containing psilocybin or active-placebo, and also take part in multiple psychotherapy sessions.
The primary outcomes for the trial are safety, efficacy and tolerability. Preliminary analysis will be carried out by an independent safety review board after the treatment of 30 patients.
Insights from that analysis will then help assist in the development and construction of Phase 2b trials.
In that context, IHL’s pre-IND submission with the FDA is an important step as part of the broader protocols for the Phase 2 trial design.
Preparations for the “larger, pivotal, multi-site phase 2b clinical trial” are ongoing, IHL said.
Commenting on the latest update, Liknaitzky highlighted the rigorous processes undertaken by IHL’s research team in the development of the psilocybin treatment.
Along with the recruitment of therapists, the team has also met its development objectives for trial protocols, treatment protocols, therapist training, site infrastructure and risk mitigation.
These steps are “all part of a solid foundation for rigorous, innovative, and patient-focused research”, he said.
“This world-first and ambitious clinical research program is rapidly developing, supported by a strong partnership between Monash and IHL.”
This article was developed in collaboration with Incannex Healthcare, 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.