Psilocybin

Major depressive disorder (MDD) is characterised by characterised by depression and inability to feel pleasure. Credit: Justin Paget via Getty Images. Johnson & Johnson’s (J&J) nasal spray Spravato (esketamine) has received a label expansion, now approved as a monotherapy treatment for major depressive disorder (MDD) in adults who do not respond to two oral antidepressants. The US Food and Drug Administration’s (FDA’s) decision makes Spravato the first-ever standalone treatment for adults with treatment-resistant depression. Initially approved in 2019 for use alongside oral antidepressants, this label expansion follows a priority review from the FDA. The approval was based on data from the Phase IV TRD4005 study (NCT04599855), which demonstrated a significant reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) total score within 24 hours after the initial dose, with effects sustained for at least four weeks. Spravato’s safety profile aligns with existing data for oral antidepressants, with no new safety concerns detected. The standard-of-care for MDD typically involves selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) as first-line treatments, often in combination with psychotherapy. However, these therapies can take weeks to exert an effect, and many patients do not respond adequately, leading to a need for innovative alternatives. Spravato targets the brain’s N-methyl-D-aspartate (NMDA) receptor. Unlike traditional MDD therapies that usually take weeks to work, J&J says this drug delivers rapid action. MDD is a severe, chronic mood disorder characterised by depression, inability to feel pleasure, guilt, low energy, and impairments in essential functioning. The global MDD market, valued at $8.8bn in 2019, is expected to grow to $16.2bn in 2029, according to a GlobalData report. GlobalData is the parent company of Pharmaceutical Technology. GlobalData notes that growth will be driven by the rising patient share of newly approved drugs, including J&J’s Spravato. Generating $689m in 2023 – nearly double its 2022 revenue of $374m – the drug’s sales are projected to reach $2.6bn by 2030. Another key contributor to this growth is Axsome Therapeutics’ Auvelity (dextromethorphan and bupropion). The company submitted a new drug application for Auvelity to the FDA for the treatment of MDD, which was accepted under priority review in April 2021. The FDA then approved Auvelity extended-release tablets in August 2022. Axsome’s drug is forecast to generate $1.9bn by 2030. With researchers looking for alternative treatments for mental health conditions, psychedelics have gained investor attention in recent years after demonstrating success in clinical trials. Psilocybin, a psychedelic prodrug compound found in more than 200 species of fungi, is currently in a Phase III programme for treatment-resistant depression with Compass Pathways .

UW-Madison, a globally recognized psychiatric research institution, will study Filament’s botanical psilocybin drug candidate, PEX010, in two clinical trials exploring neuroplasticity Vancouver, British Columbia, January 21, 2025 – Filament Health Corp. (OTCQB:FLHLF) (Cboe CA:FH) (FSE:7QS) (“Filament” or the “Company”), a clinical‐stage natural psychedelic drug development company, today announced that it has shipped its botanical psilocybin drug candidate, PEX010, to the University of Wisconsin–Madison (UW–Madison) for investigation in two clinical trials. Both trials are United States Food and Drug Administration (FDA)-authorized and will study the effects of psilocybin on neuroplasticity. “Our goal with this research is to examine how psilocybin’s effects on neuroplasticity may impact participants’ wellbeing and their ability to understand the world around them,” said Charles L. Raison, MD, principal investigator of both clinical trials and professor of psychiatry at the University of Wisconsin School of Medicine and Public Health in Madison, Wis. Research has shown that psilocybin can improve neuroplasticity — the brain's ability to reorganize and form new neural connections — which may contribute to psilocybin’s therapeutic effects. At UW–Madison, the first clinical trial studying PEX010, titled The ENHANCE Study, is being funded by the Tiny Blue Dot Foundation. Tiny Blue Dot Foundation is dedicated to advancing scientific research to help individuals understand the concept of Perception Box™, a metaphor, developed by Founder Elizabeth R. Koch which represents the internal beliefs, experiences, and biases that shape how individuals view the world and engage with others. By expanding these boundaries, individuals can reduce suffering, foster greater self-acceptance and empathy for others, and reframe trauma or challenges as opportunities for personal growth. The ENHANCE Study will dose 100 healthy volunteers to examine whether strategies that enhance psychedelic-induced neuroplasticity and increase the long-term salience of the psychedelic experience may also enhance the ability of psychedelics to support long-term enlargement of the Perception Box. The second clinical trial, titled The RECAP2 Study, will examine the proposition that the neuroplastic effects of psychedelics such as psilocybin underlie their long-term effects on wellbeing. This premise will be investigated in a cohort of 60 physically healthy volunteers with slight decline in wellbeing. “The University of Wisconsin–Madison is an internationally recognized leader in psychiatric research,” said Benjamin Lightburn, Chief Executive Officer and Co-Founder of Filament Health. “We are proud that Dr. Raison and his team have selected Filament’s drug candidate for clinical trials of this calibre and we’re pleased to support their important research.” Both clinical trials at UW–Madison are expected to begin dosing in Q1 2025. PEX010 is authorized for investigation in 41 clinical trials worldwide for 14 mental health indications. ABOUT FILAMENT HEALTH (OTCQB:FLHLF) (CBOE CA:FH) (FSE:7QS) 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. Learn more at www.filament.health and on Twitter, Instagram, and LinkedIn. MEDIA RELATIONS Anna Cordon Vice President, Marketing & Communications anna@filament.health INVESTOR RELATIONS ir@filament.health FORWARD LOOKING INFORMATION Certain statements and information contained herein may constitute “forward‐looking statements” and “forward‐looking information,” respectively, under Canadian securities legislation. Generally, forward‐looking information can be identified by the use of forward‐looking terminology such as, “expect”, “anticipate”, “continue”, “estimate”, “may”, “will”, “should”, “believe”, “intends”, “forecast”, “plans”, “guidance” and similar expressions are intended to identify forward‐looking statements or information. The forward‐looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward‐looking statements. Forward‐looking statements regarding the Company are based on the Company’s estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward‐looking statements or forward‐looking information, including status of patent applications and the ability to secure patents. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward‐ looking statements and forward‐looking information. Filament will not update any forward‐ looking statements or forward‐looking information that are incorporated by reference herein, except as required by applicable securities laws. ‍