Reset Pharma will use PEX010 in a Phase II clinical trial. Credit: Maxim Shmelyev/Shutterstock.com.

Reset Pharmaceuticals has entered a licensing agreement with Filament Health for psilocybin drug PEX010 for treating demoralisation syndrome.

The agreement grants Reset Pharma a licence to use PEX010 in a Phase II clinical trial approved by the US Food and Drug Administration (FDA).

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Filament will license its proprietary PEX010 and associated intellectual property to Reset Pharma.

The botanical drug candidate is formulated as a capsule for oral administration. It is also being assessed in several Phase I and II human clinical trials approved by the FDA and Health Canada.

Reset Pharma co-founder and interim CEO Jan-Anders Karlsson stated: “Clinical trial data indicates that psilocybin may be effective in treating demoralisation syndrome, so we are pleased to partner with Filament, a leader in the development of pharmaceutical-grade botanical psilocybin, to advance our clinical trial.

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“Reset Pharma’s lead programme focuses on developing a psilocybin-related product to treat demoralisation syndrome in patients with cancer.

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“We believe that these patients have significant levels of demoralisation with a perceived lack of control, hopelessness and helplessness and an increased risk of suicide, and currently have no effective treatment options.”

In August 2023, Filament Health received FDA approval for initiating two clinical trials at American research institutions.

These trials are intended to study the effects of PEX010 in patients with mental health conditions including cancer-related anxiety and depression.