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Research: Healthcare
Incannex has reported positive interim safety data from its ongoing Phase II PsiGAD study. A review by an independent Data Safety Monitoring Board (DSMB) identified no safety concerns from the first 37 patients enrolled (expected to recruit 72 in total) in the trial and has recommended no changes to the study design. Additionally, based on the interim analysis of 29 patients who have completed the study protocol, the company projects a more than 85% probability that the psilocybin treatment arm will provide a statistically significant benefit over the placebo treatment arm of the study. While we advise caution in the interpretation of modelling projections to predict trial outcomes, these early observations of safety and potential efficacy, in our view, support the continuation of Incannex’s psilocybin-assisted psychotherapy program for generalized anxiety disorder (GAD). We see trial completion (expected by Q423) as a key upcoming catalyst.
Written by
Incannex Healthcare |
Encouraging signals from PsiGAD interim review |
Clinical development update |
Pharma and biotech |
15 March 2023 |
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Business description
Analysts
Incannex Healthcare is a research client of Edison Investment Research Limited |
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Incannex has reported positive interim safety data from its ongoing Phase II PsiGAD study. A review by an independent Data Safety Monitoring Board (DSMB) identified no safety concerns from the first 37 patients enrolled (expected to recruit 72 in total) in the trial and has recommended no changes to the study design. Additionally, based on the interim analysis of 29 patients who have completed the study protocol, the company projects a more than 85% probability that the psilocybin treatment arm will provide a statistically significant benefit over the placebo treatment arm of the study. While we advise caution in the interpretation of modelling projections to predict trial outcomes, these early observations of safety and potential efficacy, in our view, support the continuation of Incannex’s psilocybin-assisted psychotherapy program for generalized anxiety disorder (GAD). We see trial completion (expected by Q423) as a key upcoming catalyst.
Year end |
Revenue (A$m) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
06/21 |
2.0 |
(8.2) |
(0.83) |
0.0 |
N/A |
N/A |
06/22 |
0.8 |
(14.9) |
(1.25) |
0.0 |
N/A |
N/A |
06/23e |
0.1 |
(20.7) |
(1.43) |
0.0 |
N/A |
N/A |
06/24e |
0.1 |
(33.4) |
(2.10) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalized, excluding amortization of acquired intangibles, exceptional items and share-based payments.
The ongoing Phase II PsiGAD study is assessing the effectiveness of the psychedelic, psilocybin, in conjunction with psychotherapy in patients suffering from GAD. The study is a triple-blind, active placebo-controlled trial aiming to recruit a total of 72 patients. The primary endpoint of the study is a reduction in the Hamilton Anxiety Rating Scale (HAM-A) score at 11 weeks relative to baseline. The HAM-A scale is a clinically recognized method of measuring anxiety symptoms, which has been used to support FDA approval of treatments for GAD. Patient recruitment commenced in Q1 CY22 and, to date, more than 45 participants have been enrolled, of whom 29 have completed the 10-week treatment protocol. Treatment for all 72 participants is expected to complete by Q423. We note that Incannex’s observations on the potential statistically significant benefit of psilocybin are based on extrapolating the study results from the first 29 participants to the overall cohort of 72 patients and have not been independently verified by the DSMB.
As a reminder, in February 2023, the Australian regulatory authority, the Therapeutic Goods Administration, permitted (effective 1 July) the off-label prescription of therapeutics containing psilocybin (for treatment-resistant depression) and MDMA (for post-traumatic stress disorder) by psychiatrists under controlled conditions, marking a key step towards acceptance of psychedelics as therapeutic options for mental disorders. GAD afflicts more than 3% of the US population (c 6.8 million US adults) with c 50% of treated cases not responding to first-line treatment, highlighting the significant unmet need in the space.
Final data from the PsiGAD Phase II study (expected in Q423) will be used to support an investigational new drug application with the FDA, which we see as a key inflection point for Incannex.
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Research: Healthcare
Following the protracted stalemate with the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its clinical trial authorisation (CTA) for SDC-1801, Sareum has now announced the filing of an application to commence Phase I studies for SDC-1801 in Australia under the Clinical Trial Notification scheme. The company intends to initiate the first part of the Phase Ia/b clinical trial (safety and dose-finding study in healthy volunteers) following regulatory approval, expected in Q223. This will be followed by the Phase Ib study in psoriasis patients in 2024, provided safety is established. As a reminder, in November 2022, SDC-1801’s CTA was turned down by the MHRA and Sareum has been awaiting further clarity prior to data resubmission. We note that the net cash balance at end-June 2022 stood at £4.3m and based on historical burn rates of £0.5m per quarter, we estimate Sareum to be able to commence the Phase Ia trial but it will require additional funds to advance the studies.