Filament Health Announces FDA Approval Of Two Clinical Trials Studying Its Botanical Psilocybin Drug Candidate PEX010

The University of Washington and the University of California, Los Angeles have been approved to study PEX010 in clinical trials for mental health conditions

Filament Health Corp, a clinical‐stage natural psychedelic drug development company, today announced approval from the United States Food and Drug Administration (FDA) for two clinical trials at leading American research institutions studying the effects of PEX010, Filament’s botanical psilocybin drug candidate, for mental health conditions including cancer-related anxiety and depression.

The clinical trial at the University of Washington School of Medicine is studying PEX010 for the treatment of cancer-related anxiety in patients with metastatic cancer. Evidence from a large body of scientific evidence from psychosocial group interventions for cancer patients without psychedelics suggests that the benefits of group therapy plus psilocybin could be substantial. The clinical trial is examining whether the benefits of psilocybin-assisted therapy can be realized in a group model. The trial is underway and has already dosed 5 patients.

“For patients with metastatic cancer, unrelieved anxiety and existential distress cause profound suffering,” said Dr. Anthony Back, the study’s Principal Investigator. “Existing therapies are unsatisfactory, and psilocybin-assisted psychotherapy has shown promise in treating the anxiety experienced by people living with cancer. This trial would not be possible without Filament Health’s support.”

The clinical trial at the University of California, Los Angeles (UCLA)’s Semel Institute for Neuroscience and Human Behavior will examine the effects of joining psilocybin treatment with cognitive-behavioural therapy (CBT) for patients with depression. The trial, led by Dr. Marc Weintraub, PhD, Assistant Professor of Psychiatry, will study the combination of the two treatments as it is believed that psilocybin may help facilitate the success of CBT because it encourages greater cognitive flexibility and behavioural motivation.

“We’re thrilled to announce FDA approval to study our botanical psilocybin at two leading American research institutions,” said Benjamin Lightburn, Chief Executive Officer and Co-Founder of Filament Health. “This is a significant achievement for Filament, and further highlights our capabilities as a key supplier of clinical-grade natural psychedelic drug candidate”


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