Filament Health Corp. (OTCQB: FLHLF) (NEO: FH) (FSE: 7QS) has received approval from the United States Food and Drug Administration (FDA) for two clinical trials examining the company’s psilocybin drug and its potential for treating cancer-related anxiety and depression.
The Vancouver psychedelics company announced Tuesday that the newly approved studies on its botanical psilocybin drug candidate PEX010 are being held at the University of Washington and the University of California, Los Angeles (UCLA).
The clinical study for the treatment of anxiety in patients with metastatic cancer is already underway at the University of Washington’s School of Medicine and five patients have been dosed. It will examine whether psilocybin administered among groups of patients in a single location can be beneficial.
“Existing therapies are unsatisfactory, and psilocybin-assisted psychotherapy has shown promise in treating the anxiety experienced by people living with cancer,” said Dr. Anthony Back, study lead and professor of medicine at the University of Washington.
The clinical trial at UCLA’s Semel Institute of Neuroscience and Human Behavior will examine PEX010 for the treatment of depression in combination with cognitive-behavioural therapy (CBT). Filament says psilocybin can help promote the success of CBT because it promotes improved cognitive flexibility and behavioural motivation.
“This is a significant achievement for Filament, and further highlights our capabilities as a key supplier of clinical-grade natural psychedelic drug candidates,” said the company’s Co-Founder and CEO Benjamin Lightburn.
The UCLA study will be led by Marc Weintraub, an instructor and clinical psychologist at the school’s Department of Psychiatry and Biobehavioral Sciences.
PEX010 is being studied by other companies
Filament licensed PEX010 and its associated intellectual property to Burnaby’s NeoLumina Bioscience last month to develop the drug as a treatment for eating disorders like anorexia nervosa.
Alberta’s psychedelic therapy company Atma Journey Centers also plans to examine the drug’s potential for treating mental health issues among frontline healthcare workers who dealt with stress and other difficulties during the pandemic this quarter, according to Filament.
In July, Filament announced that it planned to list on the Nasdaq exchange through a business arrangement with Jupiter Acquisition Corporation (NASDAQ: JAQC), a publicly listed entity created solely for acquisitions and mergers with other businesses. The transaction is expected to close in Q4 this year and provide Filament with US$176 million in equity value, representing US$0.85 per company share.
The company will also be providing the Canadian Institutes of Health Research with PEX010 for two upcoming clinical trials aimed at treating mental health and substance use disorders valued at $3 million.
Filament shares dropped by 3.21 per cent Thursday to $0.11 on the OTC Markets.