Highlights:
- PsiGAD1 trial achieves primary endpoint; PsiGAD psilocybin-assisted therapy demonstrated a statistically significant HAM-A reduction of 12.8 points from baseline, representing a 9.2-point improvement over psychotherapy with placebo (p <0.0001), exceeding the company’s expectations.
- 44% of patients in the psilocybin group demonstrated at least 50% reduction in anxiety score and 27% of patients showed disease remission– a remission rate more than 5 times higher than that of therapy with placebo.
- Newly developed and formulated PSX-001 psilocybin drug product has been finalised - cGMP manufacture for clinical trial supply underway.
- Incannex to submit an Investigational New Drug (IND) application with
U.S. Food and Drug Administration (FDA) to proceed to a multi-site Phase 2B trial.
The trial protocol and treatment design were developed in partnership with the
The reduction in HAM-A score from baseline in the psilocybin group was 12.8 points, from 29.5 at baseline to 16.8 at week 11 (6 weeks following the final dosing session), representing a decrease of 9.2 points over the placebo group (-12.8 psilocybin vs. -3.6 placebo; p<0.0001). 44% of patients in the psilocybin group showed a clinically meaningful improvement of at least 50% reduction in anxiety score from baseline; a ‘response rate’ more than four times higher than that of the placebo group. 27% of patients in the psilocybin group achieved full disease remission; a rate more than five times higher than that of psychotherapy with placebo.
Psilocybin within the context of PsiGAD psychotherapy was observed to be well-tolerated, with only mild and moderate adverse events (AEs) reported. The reported AEs were consistent with the known effects of the drug. No serious or severe adverse events were observed. Only one person of the 73 participants withdrew from the trial during the 7-week treatment program.
“We are thrilled with the results from our initial PsiGAD trial,” said President and CEO
Incannex have designed the follow-up Phase 2B clinical trial, PsiGAD2, with the assistance of
In parallel, Incannex has finalised the development of formulation of its psilocybin drug product, PSX-001. Final preparations for the manufacture of the cGMP clinical trial supply of PSX-001 are underway. Documentation on the formulation development and cGMP manufacture will form the final pieces of the FDA IND application that Incannex commenced in August of 2023. Clearance of the IND by the agency is required for the Company to conduct the PsiGAD2 study at sites in the US.
Incannex is continuing to work with
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
This announcement has been approved for release to NASDAQ by the Incannex Board of Directors.
About
Incannex is a clinical stage pharmaceutical development company that is developing unique medicinal cannabis 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.
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 19 granted patents and 30 pending patent applications. Incannex is listed on the NASDAQ as IXHL
Website: www.incannex.com.au
Investors: investors@incannex.com.au
Forward-looking statements
This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the
Contact Information:
Mr
Chief Executive Officer, President and Director
admin@incannex.com.au
Investor Relations Contact –
+1 (610) 716 2868
lyonker@edisongroup.com
Appendix: Comparison of PsiGAD Treatments to Existing Registered Treatments for Anxiety
Figure: meta-analysis1 of psychotropic medications for GAD, as measured by the HAM-A; the best medication that was coded as having reliable (larger sample size) results in this analysis, quetiapine, has a between group difference in effect of -3.60 on the HAM-A. Note, some studies included in this meta-analysis were considered unreliable by the authors.
1 Slee, A., Nazareth, I., Bondaronek, P., Liu, Y., Cheng, Z., & Freemantle, N. (2019). Pharmacological treatments for generalised anxiety disorder: a systematic review and network meta-analysis.
An infographic accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/bacb6159-feb6-4794-ae7f-2a0303debb18
Appendix: Comparison of PsiGAD Treatments to Existing Registered Treatments for Anxiety
Figure: meta-analysis(1) of psychotropic medications for GAD, as measured by the HAM-A; the best medication that was coded as having reliable (larger sample size) results in this analysis, quetiapine, has a between group difference in effect of -3.60 on the HAM-A. Note, some studies included in this meta-analysis were considered unreliable by the authors.
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