Incannex submits HREC proposal and FDA pre-IND meeting request for Psi-GAD psilocybin therapy for Generalised Anxiety Disorder

2021-08-10 04:32:32 (AET) by Ring Zhang   587


Clinical stage pharmaceutical development company, Incannex Healthcare Limited (ASX: IHL) announced today that it has submitted the Human Research ETHICS Committee (‘HREC’) proposal and the US FDA pre-IND meeting request for its phase 2a clinical study for Generalised Anxiety Disorder (‘GAD’).

Clinical stage pharmaceutical development company, Incannex Healthcare Limited (ASX: IHL) announced today that it has submitted the Human Research ETHICS Committee (‘HREC’) proposal and the US FDA pre-IND meeting request for its phase 2a clinical study for Generalised Anxiety Disorder (‘GAD’).

Incannex has submitted a comprehensive information package to the US FDA for the purpose of requesting a pre-IND meeting. The information package and meeting request was prepared in conjunction with regulatory specialist Camargo Pharmaceuticals. And the submission to HREC is for ethics review for the study.

Both submissions follow an extensive and collaborative trial design process led by Principal Investigator Dr Paul Liknaitzky along with Co-Investigators Professor Suresh Sundram. Incannex expects the 2a clinical trial to commence in 2021 and the phase 2b trial in 2022.

Guidance from the FDA meeting along with the study results from the 2a clinical study will be used for the 2b trial design and an investigational new drug application (IND) application with the FDA.

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The Trial Design of 2a Clinical Study

The Psilocybin-assisted psychotherapy clinical study for GAD was initially announced by Incannex in December 2020 with the goal of filling the medical gap for this common disorder. According to the announcement, the fact that it involved 72 patients and is in joint force with the world's top 100 Monash University makes it the largest psychedelic R&D project in Australia and is anticipated to have a substantial impact on the field globally.

The phase 2a study is a randomised triple-blind, active-placebo-controlled trial. Participants will be administered two psilocybin or active-placebo dosing combined with up to 11 non-drug, specialist psychotherapy sessions that last 10 weeks.

The primary outcomes of the study are safety, efficacy and tolerability, and secondary outcomes are quality of life, functional impairment, and comorbidities.

The trial will be conducted at BrainPark, the state-of-art Monash University’s Turner Institute for Brain and Mental Health, led by Dr Paul Liknaitzky with an expert team from both Psychological Sciences from the Monash University School and the Department of Psychiatry.

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About Generalised Anxiety Disorder

Generalised Anxiety Disorder (GAD) is a global health issue characterised by diffuse, excessive, uncontrollable anxiety that is not restricted to any specific environmental circumstances and occurs more days than not for at least 6 months. In the USA and Australia, it is estimated that 3% of the adult population have GAD in any 12 months period. Patients experience intense, persistent, and often debilitating anxiety.

First-line treatment options for GAD include Cognitive Behavioural Therapy, anti-depressants (SSRIs, SNRIs) and pregabalin, with benzodiazepines (e.g., Diazepam) as a second-line, short-term option. Existing treatments show limited efficacy, with less than 50% of patients achieving remission, alongside high relapse rates. These treatment limitations highlight the significant unmet needs in this patient group.


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Source: Incannex submits HREC proposal and FDA pre-IND meeting request for Psi-GAD psilocybin therapy for Generalised Anxiety Disorder


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