Filament Health gets FDA nod for meth addiction study

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Filament also announced a financing deal for C$1 million.

Filament Health Corp. (OTCQB: FLHLF) (Cboe CA: FH) announced Health Canada and the United States Food and Drug Administration (FDA) authorization for a Phase 2 clinical trial of PEX010, Filament’s botanical psilocybin drug candidate, for the treatment of methamphetamine use disorder (MAUD). The company stated this would be the first-ever clinical trial to study the safety and efficacy of botanical psilocybin in a MAUD patient population.

“The prevalence of methamphetamine use disorder has rapidly increased worldwide over the last decade, with the highest rate of use in North America,” said Dr. Christian Schütz, Professor of Psychiatry at the University of British Columbia and Principal Investigator for the trial. “Existing clinical data indicates that psilocybin shows promise for the treatment of MAUD. Our aim with this trial is to assess the safety and efficacy of PEX010 in the treatment of MAUD, and to evaluate changes in participants’ substance use, cravings, motivation, and recovery capital. We are grateful to Filament Health for funding and facilitating this much-needed research.”

Filament told investors that the randomized, double-blinded, placebo-controlled clinical trial would evaluate approximately 90 patients with amphetamine-type stimulant use disorder. The primary efficacy endpoint is the change in the overall response rate based on clinically assessed criteria over the 3-month treatment period.

The company said that patients assigned to the PEX010 arm would be treated with a single dose of PEX010 25mg in addition to psychotherapy. The company said it expects to initiate dosing at UBC in the second half of 2024.

“These authorizations are a significant milestone in Filament’s mission to support the treatment of substance use disorders with naturally-derived psychedelics,” said Benjamin Lightburn, Chief Executive Officer and Co-Founder of Filament Health. “As a Vancouver-based company, the challenges faced by those in our community who are suffering from MAUD and the toxic drug crisis are close at hand. We are proud to sponsor this crucial research, and to partner with Dr. Schütz and his team.”

Earlier this year, Filament announced that the FDA accepted an Investigational New Drug application for PEX010 for SUD with an initial study in opioid use disorder.

Financing

Filament also announced that it had entered into agreements with on of its existing investors,  Negev Capital Fund One and Lightburn to complete a C$1.0 million bridge financing.

Ken Belotsky, Partner at Negev Capital. “Filament is strategically positioned to combat substance use disorders, leveraging its groundbreaking botanical drug development platform and an industry-leading intellectual property portfolio.”

Negev will exercise its outstanding warrants to buy 17,284,443 common shares in the capital of the company and will convert its outstanding C$1.25 million convertible note, due July 13, 2024, into 25,000,000 Common Shares. In consideration for the immediate exercise of the Warrants for cash, Filament has agreed to reduce the exercise price of such Warrants to C$0.05 per share. Lightburn will buy 2,700,000 Common Shares, also for C$0.05 per share for gross proceeds to the company of C$0.1 million.

Green Market Report had previously written that Filament’s cash was running low as the company reported $872,048 in cash and equivalents as of March 31. That’s after using $949,606 for operating activities in the fiscal first quarter of 2024. Total revenues for the quarter were $297,932 while working capital stood at $359,664.

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