Psilocybin treatment beats placebo in Incannex anxiety study

The firm is planning a subsequent Phase 2B trial.

New-York based Incannex Healthcare Inc. (Nasdaq: IXHL) reported positive results from its Phase 2 Psi-GAD1 clinical trial assessing the effectiveness of psilocybin in treating generalized anxiety disorder (GAD).

The trial, conducted in partnership with Monash University’s Clinical Psychedelic Lab and led by Dr. Paul Liknaitzky, looked to evaluate the efficacy of psilocybin compared to a placebo.

“We are thrilled with the results from our initial PsiGAD trial,” President and CEO Joel Latham said in a statement. “The safety and efficacy results from PsiGAD1 implore us to continue the development of PsiGAD through large scale well-controlled trials.”

Results indicated that the psilocybin group experienced a significant decrease in anxiety, with a reduction of 12.8 points on the Hamilton Anxiety Rating Scale (HAM-A) from baseline, versus a 3.6-point decrease in the placebo group.

Additionally, the study reported that 44% of participants in the psilocybin group saw at least a 50% reduction in anxiety scores from baseline, a rate four times higher than that observed in the placebo group. The treatment was generally well tolerated, with no severe adverse events noted.

Following the positive outcomes of the Psi-GAD1 trial, Incannex plans to further explore the treatment’s effectiveness with a subsequent Phase 2B trial, PsiGAD2. That next phase will be conducted in collaboration with Clerkenwell Health and will include multiple trial sites across the U.S. and U.K.

In parallel, Incannex is progressing with the development and regulatory steps for its psilocybin drug product, PSX-001, as part of its efforts to secure approval for further clinical trials in the U.S.

The clinical stage pharmaceutical company, originally based in Australia and now redomiciled in the U.S., focuses on developing medicinal cannabis products and psychedelic medicine therapies.

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