Full Press Release Details
Incannex Healthcare September 2023 Quarterly
Activities Report and Appendix 4C Cash Flow Statement
Melbourne, Australia, October 26, 2023 - Clinical
stage pharmaceutical development company, Incannex Healthcare Limited (ASX: IHL) (NASDAQ: IXHL), ( Incannex' or the Company'),
is pleased to provide its quarterly activities report and appendix 4C for the period ended 30 September 2023. Incannex is undertaking
a multitude of U.S. Food and Drug Administration ( FDA') research and development ( R&D') programs for cannabinoid
pharmaceutical products and psychedelic medicine therapies administered by health professionals.
FDA IND approval to commence IHL-42X phase
2/3 clinical trial for patients with obstructive sleep apnoea
the quarter, Incannex received approval from the US Food and Drug Administration (FDA) to proceed with its Investigational New Drug (IND)
opening pivotal IHL-42X Phase 2/3 clinical trial in the United States. The trial, planned for patients with obstructive sleep apnoea who
are non-compliant, intolerant, or new to positive airway pressure treatment, will assess the effects of IHL-42X, dronabinol, acetazolamide,
and a placebo. Participants will undergo daily sleep quality surveys, monthly clinic visits to evaluate sleep outcomes and safety, and
regular polysomnography to assess the impact of treatments on Apnoea Hypopnea Index (AHI) and other sleep parameters. Combining
Phase 2 and Phase 3 in a single Phase 2/3 trial allows for a more efficient transition from the early stages of testing (Phase 2) to the
final stages required for regulatory approval (Phase 3), potentially accelerating the availability of this new treatment to patients subject
to continued clinical success.
At the time, CEO and Managing Director of Incannex,
Mr Joel Latham said, "The initial Phase 2 proof of concept clinical trial over IHL-42X demonstrated an average reduction in our
primary end point, AHI of 50.7%, with 25% of subjects having a reduced AHI of >80%. Importantly, we also observed a reduction in average
patient oxygen desaturation index of 59.7%, markedly improved sleep quality and a reduction in cardiovascular stress. These results were
truly remarkable and now allows for this Phase 2/3 trial to be a genuine long-term safety and efficacy trial. If we again observe such
remarkable drug efficacy, safely administered over the 52 weeks, Incannex is confident that our product will be marketable."
Since the FDA provided clearance for the IND opening
study to begin, startup of the IHL-42X Phase 2/3 clinical trial IHL-42X has progressed rapidly. The trial, which has been given the name
RePOSA, derived from Revealing the Efficacy of IHL-42X use in Patients with OSA,
will assess the safety and efficacy of IHL-42X compared to the component active pharmaceutical ingredients, dronabinol and acetazolamide,
Incannex Healthcare Limited (ABN: 93
Level 39, Rialto South Tower, 525 Collins
Street, Melbourne VIC 3000
Incannex have been working with Fortrea, the contract
research organisation ( CRO') engaged to manage the trial, to assess and formally engage sites in the US, Europe, Australia
and New Zealand. The site selection/approval process and preparation of institutional review board (IRB) packages is proceeding as planned.
Incannex is also working with vendors for the operation of the study, including central readers for polysomnography, central laboratory
services for assessment of blood samples for safety markers, coordination of drug product packaging and labelling for blinded clinical
trials, as well as distribution chains to trial sites. These are operational considerations to ensure that the multi-site global clinical
trial is run efficiently and according to the necessary regulatory requirements. Trial updates will continue to be provided to investors
as major milestones are achieved.
There are no registered pharmacotherapy (drug)
treatments available to people with OSA, representing a major economic opportunity to Incannex with IHL-42X, should the study achieve
its endpoints as in the proof-of-concept trial.
IHL-42X bioavailability/bioequivalence study
Screening for the IHL-42X bioavailability/bioequivalence
(BA/BE) study commenced on 8 September 2023, and dosing of trial participants commenced on 6th October 2023. Four groups of
participants have completed at least one dosing session at CMAX Clinical Research in South Australia. The first group have completed 3
of 4 dosing sessions and will complete their final dosing session on 27th October. Patient recruitment, dosing, and assessment
will continue according to the trial schedule towards completion. The aim of the trial is to assess the safety, tolerability and pharmacokinetics
of IHL-42X at scale compared to the reference listed drugs for the active pharmaceutical ingredients, dronabinol and acetazolamide, in
healthy volunteers. The trial is also assessing the effect of food on the safety, tolerability and pharmacokinetics of IHL-42X. Updates
on patient recruitment, dosing and other study milestones will be provided to investors as they occur.
Clarion Clinics: psychedelic-assisted psychotherapy
clinics ready to launch services following receival of all approvals
Clarion Clinic, the first of its kind, located
on the Yarra Riverfront in Abbottsford, Melbourne has been designed and fitted out specifically to provide the optimal environment for
psychedelic-assisted therapy. With seven treatments rooms and a group therapy room, the clinic is a commercial scale prototype and has
the capacity to treat approximately 600 people per year in normal working hours and substantially more in extended hour operations. Future
clinics are expected to be significantly larger. Photos of the clinic are attached.
Incannex Healthcare Limited (ABN: 93
Level 39, Rialto South Tower, 525 Collins
Street, Melbourne VIC 3000
In order to be able to treat people with psychedelic-assisted
therapy, Clarion is required to attain approval from a Human Research Ethics Committee (HREC), the TGA Authorised Prescriber Scheme and
State Health Authorities. This process is well underway and interim feedback has been positive. While Clarion doesn't control the
timelines involved in this process making it hard to predict a firm date, it is making good progress and hopes to have all approvals in
place to commence treatment in November, assuming no unforeseen issues arise.
Since Clarion launched its website in August,
it has received substantial interest in its treatments. Potential patients are being placed on a waiting list in the order of their application.
"The level of interest in treatment before any major marketing push is indicative of the pent-up demand. People are actively seeking
out places which will be able to perform this type of treatment." Peter Widdows, IHL Director responsible for Clarion Clinics establishment
Critically, Clarion has assembled a motivated
team of psychiatrists, psychologists and psychotherapists who, along with Clarion's clinical founders, are amongst the most experienced
psychedelic-assisted therapy experts in Australia. "People who have experience with this kind of therapy are few and far between
in Australia and we're privileged to have such a strong team at Clarion. The quality of our team and our patient centric philosophy
are key to making sure Clarion is the clinic patients will seek out to give themselves the best chance of a successful treatment outcome".
Clarion Clinics is at the leading edge of mental
healthcare not just locally, but globally and its bespoke treatment protocols offer the hope of sustained improvement for the 670,000
Australians suffering from Post-Traumatic Stress Disorder (PTSD) and Treatment-Resistant Depression (TRD) and potentially, legislation
allowing, the tens of millions of people worldwide. "Being the first dedicated clinic to offer this treatment, while having it's
challenges, is well worth the effort and will put Clarion well ahead of the pack, giving it a ready model to work with and expand both
in Australia and internationally." Widdows commented.
Clarion Clinics is exploring numerous potential
patient treatment funding pathways, both governmental and private, and remains optimistic that there should be multiple funding opportunities
for eligible patients in the future. While the upfront cost of $22-25,000 is high, due to the requirement for extensive psychotherapy
and psychiatry provided over a multi-month period, for potential funding partners, it needs to be assessed versus the lifetime of medication,
psychiatry, psychotherapy and lost productivity which they are currently funding. "The most important point will always be that
it offers people who are suffering debilitating conditions a chance for sustained improvement in their mental wellness, but the opportunity
for funding bodies to reduce their future liabilities and deploy their resources across other areas in need cannot be underestimated."
Incannex Healthcare Limited (ABN: 93
Level 39, Rialto South Tower, 525 Collins
Street, Melbourne VIC 3000
"I'm very encouraged by the progress
Clarion has made in such a short time since the down-scheduling. The level of demand from potential patients shows that this treatment
has found its time. The potential for funding pathways is also very positive progress and could make this vital treatment accessible for
many more people who need it. Clarion Clinics is a potential multi-billion-dollar initiative which will address a significant community
need for better mental health treatments." Joel Latham, Managing Director and CEO of IHL commented.
Images of the interior and exterior of the Melbourne clinic
FDA IND application for Psi-GAD - psilocybin-assisted psychotherapy
for generalised anxiety disorder
During the quarter, Incannex commenced preparations
for an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for its psilocybin-assisted psychotherapy