Published on
January 31, 2022

Filament Health And Cybin Therapeutics Announce Approval For Phase II Clinical Trial For Depression

Trial to investigate the effects of Filament's botanical psilocybin drug candidate and Cybin Therapeutics' protocols in treating major depressive disorder in patients taking SSRIs.

Patient enrollment is expected to commence in Q3'22

VANCOUVER, BC, Jan. 31, 2022 /CNW/ - Filament Health Corp. (OTCQB: FLHLF) (NEO: FH) (FSE: 7QS) ("Filament" or the "Company"), a clinical-stage natural psychedelic drug development company, today announced Health Canada approval for a phase 2 clinical trial using PEX010, the Company's botanical psilocybin drug candidate. Cybin Therapeutics ("CT"), a private therapeutic bioscience company on a mission to discover and develop psilocybin assisted therapeutic protocols, has licensed PEX010 (25 mg) from Filament for use in the trial. The trial is expected to begin in Q3'22 and will include individuals with major depressive disorder who are undergoing selective serotonin reuptake inhibitor (SSRI) therapy, commonly used to treat depression, as well as those who are SSRI-naive.

"Health Canada's approval is a testament to both the validity of this trial as well as Filament's ability to produce and license pharmaceutical-grade botanical drug candidates," said Filament Chief Executive Officer, Benjamin Lightburn. "The effect of psilocybin therapy in patients taking traditional SSRI antidepressant medication is an extremely important investigation and we are thrilled to participate in this important research."

"Many Canadians who battle depression undergo SSRI therapy, and until now, this has generally meant exclusion from psychedelic assisted psychotherapy (PAP) clinical trials," said Josh Taylor, Founder of Cybin Therapeutics. "If it can be demonstrated that PAP can be safely and effectively given to patients on SSRIs, many will stand to benefit. We feel this is an outstanding opportunity to show Health Canada that Cybin Therapeutics can improve patient outcomes with our team and developed protocols."

Filament has also licensed PEX010 (25 mg) to CT for additional phase 2 clinical trials, which are expected to begin in the fourth quarter of 2022. Both trials will be led by Dr. Reg Peters and Dave Phillips.

Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament's platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates.

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Cybin Therapeutics ("CT"), is a private therapeutic bioscience company established in 2019, on a mission to develop psilocybin-assisted therapeutic protocols and natural formulations to treat mild mood disorders and addictions. Cybin Therapeutics works with healthcare specialists who together form a dynamic clinical team with the ability to carry out studies and clinical trials for Cybin Therapeutics and it's future partners looking to conduct psilocybin based studies and trials.

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