Incannex says psilocybin therapy lowered anxiety in small study

An Australian-based biotechnology company says a mid-stage clinical trial has shown that psilocybin, a psychedelic compound found in many mushroom species, helped people with generalized anxiety disorder.

The trial recruited 73 participants, giving some psilocybin and others placebos, though they all received psychotherapy. According to Incannex Healthcare, whose work focuses on cannabinoid and psychedelic medicine, the study hit its main goal, as psilocybin demonstrated a significantly larger clinical effect.

Researchers used a well-known scale to evaluate participants, with higher scores equating to severe anxiety symptoms. Eleven weeks into the study, scores had decreased 12.8 points in the psilocybin group versus 3.6 points in the placebo group.

Additionally, anxiety scores dropped by more than half in 44% of psilocybin-treated patients, a response rate Incannex highlighted as “more than four times higher than that of the placebo group.” And at 27%, the proportion of patients in the drug arm who experienced full disease remission was more than five times higher than the control arm.

Incannex said patients tolerated psilocybin well. There were no serious or severe adverse events, and just one person withdrew from the trial. The company didn’t specify the mild to moderate adverse events that researchers observed, but noted they were “consistent with the known effects of the drug.”

In a statement, Incannex president and CEO Joel Latham said the results “implore us to continue the development of [the program] through large scale well-controlled trials, because this treatment method has the potential to improve the quality of life for millions of people suffering from generalized anxiety disorder.”

Incannex has already designed a follow-up mid-stage study that will take place at multiple sites in the U.S. and U.K. The company has also finalized the formulation of its psilocybin drug product, named PSX-001, and is preparing to manufacture the supply necessary for clinical trials. However, it still needs clearance from the Food and Drug Administration to test PSX-001 at sites in the U.S.

Shares of Incannex that trade on the Nasdaq stock exchange were up nearly 55% by late morning Tuesday, cresting just over $6.50 apiece.

Recently, investors have intrigued by psychedelic drugs and their potential ability to treat mental health conditions. Just last month, a company developing an ecstasy-based therapy for post-traumatic stress disorder said it had raised north of $100 million through a Series A financing round that received more interest than expected. In 2021, Atai Life Sciences, a German biotech with a similar program, raised $225 million by going public.

Andrew Tsai, an analyst at the investment firm Jefferies, wrote in a note to clients early this year that the “psychedelic landscape seems to be evolving favorably” for drugmakers.

The need for more and better treatments is high across many mental disorders, which, for developers, presents significant commercial opportunities if they can bring drugs to market. Johnson & Johnson’s Spravato, for example, is a form of ketamine that was approved in 2019 for treatment-resistant depression. According to Tsai’s estimates, Spravato is poised to hit $725 million in annual sales.

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