The FDA authorized an investigator-initiated Phase 2 trial evaluating Cybin Inc's CYBN psychedelic-assisted psychotherapy with psilocybin for frontline clinicians experiencing COVID-related distress.
- The trial will be conducted at the University of Washington. It will aim to treat depression, anxiety, burnout, and post-traumatic stress symptoms among frontline doctors, nurses, and healthcare professionals.
- The study has also received Institutional Review Board (IRB) approval at the University of Washington. This investigator-initiated trial will be hosted in Seattle and will be funded by multiple organizations.
- The Phase 2 clinical trial will enroll 30 frontline clinicians.
- The primary outcome will be a comparison between the two groups in depression and anxiety as measured by the Montgomery Asberg Depression Rating Scale (MADRS) total at four weeks post-dose session.
- "Learnings from this combination Phase 2 trial will inform the use of EMBARK in Cybin's upcoming human studies using CYB003, a proprietary deuterated psilocybin analog with a potential to reduce clinic times and dosing levels in half as well as potentially reduce side effects and adverse events," said Doug Drysdale, CEO.
- Price Action: CYBN shares are down 5.42% at $1.39 during the market session on the last check Tuesday.
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