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Tuesday, Jul 8, 2025
Mugglehead Investment Magazine
Alternative investment news based in Vancouver, B.C.
FDA gives another one of Filament Health's psilocybin drug trials the green light
FDA gives another one of Filament Health's psilocybin drug trials the green light
At this year's Psychedelic Science conference, a researcher presented data showing that one dose of psilocybin could alleviate depression for 5 years. Photo credit: Filament Health

Psychedelics

FDA gives another one of Filament Health’s psilocybin trials green light

The news follows the agency approving a Phase 2 study on PEX010 for different indications in April

Filament Health Corp (OTCMKTS: FLHLF) (FRA: 7QS) has received FDA approval for another clinical trial on its lead drug candidate PEX010.

This time around, the psychedelic drug developer will be assessing the psilocybin-derived therapeutic for the treatment of PTSD and alcoholism in veterans and first responders. More specifically, it will focus on treating trial participants who suffer from these conditions simultaneously. It is the first to do so.

The state of Washington is funding this Phase 2 investigation. It will be led by addiction psychiatry expert Dr. Nathan Sackett. Enrolment is ongoing and results are scheduled to be released late next year.

“Despite significant overlap between alcohol use disorder and post traumatic stress disorder, there is a lack of evidence-based treatment options for people experiencing both conditions,” Sackett, from the University of Washington, highlighted in Filament’s news release, “particularly among veterans and first responders, who are disproportionately affected.”

Filament’s most extensively studied psychedelic therapeutic is also currently being assessed in an opioid use disorder study at the University of Pennsylvania. Additionally, researchers at Imperial College London have been examining the psilocybin drug’s potential for treating this troubling variety of addiction.

“We know that up to 90 per cent of people relapse back to opioid use within 12 months of finishing detox,” said Dr. David Erritzoe, Clinical Director of Imperial College London’s Centre for Psychedelic Research, in an article last fall.

“So finding new and effective treatments is essential.”

PEX010 is the focus of an ongoing trial with patients suffering from prolonged grief disorder at Linkoping University in Sweden as well.

On the financial front, Filament’s recent performance has been concerning. Sliding revenue, a low cash balance and a significant accumulated deficit have made buying shares a questionable prospect. The psychedelic medicine pioneer reported a net loss of C$4.7 million last year.

At the end of May, Filament’s stock was downgraded from the OTCQB market to the OTC Pink.

Read more: Psychedelic drug developer Cybin secures major financing deal

Read more: One dose of psilocybin can alleviate depression for 5 years, U.S. researchers find

 

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