FDA Review of PsiGAD2 IND complete; clinical trial for Psilocybin Assisted Psychotherapy in Patients with Generalised Anxiety Disorder to Proceed
August 05 2024 - 7:30AM
Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex’ or the
‘Company’), a clinical-stage pharmaceutical company developing
proprietary medicinal cannabinoid products and psychedelic assisted
psychotherapies is pleased to announce that it has received
approval from the US Food and Drug Administration (‘FDA’) to
conduct the Company’s Investigational New Drug (‘IND’) opening
Phase 2 clinical trial. The trial will investigate Incannex’s
psilocybin pharmaceutical formulation, known as PSX-001, in
conjunction with psychotherapy in patients with generalised anxiety
disorder in the United States and the United Kingdom.
Incannex submitted the IND application on 26
June 2024 and the FDA completed their review of the application
package during the allocated 30-day period. Incannex received
communication that the FDA review was completed, and the
IND-opening clinical trial, PsiGAD2, is deemed safe to proceed
following assessment of the trial protocol, lead trial
investigator, and a risk benefit analysis of the trial and
prospective drug product.
PsiGAD2 will recruit approximately 94 patients
with generalised anxiety disorder, including those currently being
treated with selective serotonin reuptake inhibitors, who meet the
study inclusion and exclusion criteria. Patients will receive one
of two dose strengths of PSX-001 under double blind conditions.
There will be two dosing sessions for all patients as well as
preparatory and integration sessions to facilitate
psychotherapy.
The primary endpoint for the study will be
change in HAM-A score, a widely used and validated measure of
anxiety, two weeks after completion of the second dosing session.
HAM-A scores will be collected at predefined intervals for 23 weeks
after completion of the dosing sessions and the change from
baseline assessed as secondary study endpoints. Additional
endpoints in the study will include measures of quality of life,
healthcare utilisation, electroencephalography (EEG), as well as
assessment of safety and tolerability through adverse event
monitoring.
The PsiGAD2 trial builds on the positive results
of PsiGAD1, a phase 2 proof of concept clinical trial conducted at
world renown Monash University. That trial reported a 12.8 point
reduction in HAM-A score in the psilocybin treatment group, which
was 9.2 points greater than observed for the placebo group
(p<0.0001). In PsiGAD1, 44% of patients in the psilocybin group
had a greater than 50% reduction in HAM-A score and 27% of patients
achieved disease remission.
PsiGAD2 is also currently under review by the
Medicines and Healthcare Products Regulatory Agency (MHRA) in the
United Kingdom (UK) to permit the Company to conduct the trial also
at sites in the United Kingdom. Incannex will continue start up
activities for the PsiGAD2 trial in the UK in parallel with start
up in the US.
About Generalised Anxiety
Disorder
Generalised Anxiety Disorder (GAD) is
characterised by excessive anxiety and worry that occurs more days
than not for at least 6 months and is not restricted to any
particular environmental circumstances. Symptoms are variable,
including feelings of persistent and excessive worry, nervousness,
restlessness, difficulty concentrating, and a range of somatic
manifestations. People with GAD find it difficult to control their
worry, which may cause significant distress and impairment in
social, occupational, or other areas of functioning. GAD is a
relatively common disorder (about 6-9% lifetime prevalence, and
about 3% 12-month prevalence in countries like Australia and the
United States). As with other mood disorders, successful treatment
of GAD remains inadequate, with less than half of patients
achieving remission following evidence-based treatment, alongside
high relapse rates, and substantial treatment side-effects or
cost.
About Incannex Healthcare Inc.
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.
U.S. FDA approval and registration, subject to
ongoing clinical success, is being pursued for each drug and
therapy under development. Each indication under investigation
currently has no, or limited, existing registered pharmacotherapy
(drug) treatments available to the public and represent major
global economic opportunities to Incannex and its shareholders.
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. Incannex
is listed and publicly traded on Nasdaq (NAS: IXHL), providing
investors an opportunity to participate in the Company's
growth.
Website:
www.incannex.com Investors:
investors@incannex.com.au
Forward-looking statementsThis
press release contains "forward-looking statements" within the
meaning of the "safe harbor" provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These forward-looking
statements are made as of the date they were first issued and were
based on current expectations and estimates, as well as the beliefs
and assumptions of management. The forward-looking statements
included in this press release represent Incannex's views as of the
date of this press release. Incannex anticipates that subsequent
events and developments may cause its views to change. Incannex
undertakes no intention or obligation to update or revise any
forward-looking statements, whether as of a result of new
information, future events or otherwise. These forward-looking
statements should not be relied upon as representing Incannex's
views as of any date after the date of this press release.
Contact Information:
Incannex Healthcare Inc.Mr Joel
LathamChief Executive Officer, President and
Directoradmin@incannex.com.au
Investor Relations Contact – United States
Jennifer Drew-Bear Edison GroupJdrew-bear@edisongroup.com
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