Psilocybin

Open-label study at Psychiatric Centre Copenhagen found that alcohol consumption significantly decreased amongst participants dosed with Filament’s botanical psilocybin drug candidate After a single dose of PEX010, the mean percentage of heavy drinking days was reduced by more than 50% over the 12-week observation period Vancouver, British Columbia, March 17, 2025 – Filament Health Corp. (OTCQB:FLHLF) (CBOE:FH) (FSE:7QS) (“Filament” or the “Company”), a clinical‐stage natural psychedelic drug development company, today announced positive data from an open-label phase 2 clinical trial studying the effects of its botanical psilocybin drug candidate, PEX010, for the treatment of alcohol use disorder (AUD) at Psychiatric Centre Copenhagen. The results were published in the Journal of Psychopharmacology and found that a single 25mg dose of PEX010 was safe and effective in reducing alcohol consumption in AUD patients. “We are thrilled to announce positive results which support the efficacy of PEX010,” said Benjamin Lightburn, Co-Founder and Chief Executive Officer at Filament Health. “These data reinforce our confidence in the potential of botanical psilocybin to help the millions of people suffering from substance use disorders like AUD. We look forward to advancing to the next stage of development.” The open-label phase 2 study investigated single-dose psilocybin therapy in 10 treatment-seeking adults with severe AUD. The treatment involved two preparation sessions, a high-dose psilocybin session (25 mg), and two integration sessions. Alcohol consumption significantly decreased over the 12 weeks following the administration of PEX010. The percentage of heavy drinking days was reduced from 53.6% before receiving PEX010 to 16.1% at week 12 and drinks per day decreased by an average of 3.4 drinks over the 12-week follow up period. This was corroborated by reports of rapid and sustained reductions in craving and temptation and significant increases in self-efficacy. All participants completed the therapy course, and the safety profile was favourable with no serious adverse events. “These results highlight the promising potential of psilocybin as a treatment for alcohol use disorder,” said Dr. Mathias Ebbesen Jensen, MD, PhD-student at Psychiatric Centre Copenhagen and the trial’s Co-Principal Investigator. “Our findings suggest that this therapy could offer a much-needed novel approach and we are currently investigating PEX010 for AUD in a larger randomized, placebo-controlled trial to establish firm conclusions.” PEX010 is authorized for investigation in 51 clinical trials worldwide for 14 mental health indications. 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. Anna Cordon, Vice President, Marketing & Communications anna@filament.health ir@filament.health Certain statements and information contained in this press release and the documents referred to 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 the timing and results of clinical trials, the ability of the parties to receive, in a timely manner and on satisfactory terms, the necessary regulatory, court and shareholders approvals; the ability of the parties to satisfy, in a timely manner, the other conditions to the completion of the proposed business combination; other expectations and assumptions concerning the transactions contemplated in the proposed business combination; the available funds of the parties and the anticipated use of such funds; the availability of financing opportunities; legal and regulatory risks inherent in the psychedelic drug development industry; risks associated with economic conditions, dependence on management and currency risk; risks relating to U.S. regulatory landscape; risks relating to anti-money laundering laws and regulation; other governmental and environmental regulation; public opinion and perception of the psychedelic drug development industry; risks related to the economy generally; risk of litigation; conflicts of interest; risks relating to certain remedies being limited and the difficulty of enforcement of judgments and effect service outside of Canada; and risks related to future acquisitions or dispositions. 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. ‍

MONDAY, March 3, 2025 -- People who land in the ER after using hallucinogens are more than twice as likely to die in a handful of years, a new study says. Psychedelics users treated at a hospital are 2.6 times more likely than average folks to die from any cause within five years, researchers reported in the Canadian Medical Association Journal . They specifically were more likely to die by suicide, cancer, lung disease and overdose compared to the general public, researchers found. “The findings highlight the need for ongoing investigation of and communication about both potential benefits and risks from hallucinogen use, particularly use outside clinical trial settings, given rapid increases in general population use,” senior researcher Dr. Marco Solmi , an associate professor of psychiatry at the University of Ottawa, said in a news release. The use of hallucinogens like ketamine , psilocybin, LSD, ayahuasca and ecstasy has rapidly increased since the mid-2010s, driven by clinical trials supporting their potential use in treating mental health and substance use disorders, researchers said in background notes. The percentage of U.S. residents reporting that they used hallucinogens more than doubled from nearly 4% in 2016 to almost 9% in 2021, researchers said. However, there isn’t much data on whether these drugs could increase a person’s risk of death when they’re used outside carefully controlled settings, researchers said. For the new study, researchers analyzed records on ER visits or hospitalizations among more than 11.4 million people 15 and older living in Ontario, Canada from 2006 to 2022. Overall, researchers found a 2.6-fold increased risk of early death among people who required treatment after using a hallucinogen. The risk was even higher -- 3.2-fold -- after researchers excluded people who had mental health or substance use disorders, results show. People who required care for hallucinogen use also had increased risks related to specific causes of death: These risks were higher than those of people who sought hospital care linked to alcohol consumption, but lower than people who needed care for opioid or stimulant use, researchers noted. Psychedelics might increase a person’s risk of suicide if they’re used outside a clinical setting researchers said. People taking hallucinogens also might be liable to take other drugs, increasing their risk of overdose. Further, people who needed hospital care for hallucinogen use were more likely to live in low-income neighborhoods, to have been homeless, to have chronic health problems, and to have been treated for a mental health or substance use disorder in the previous three years, researchers added. “Despite the growing popularity of hallucinogen use, we know surprisingly little about potential adverse effects of hallucinogens, such as mortality risks,” lead researcher Dr. Daniel Myran , research chair in social accountability at the University of Ottawa, said in a news release. “Contemporary clinical trials have not observed any short-term increase in risk of severe adverse events, including death, for trial participants,” Myran said. “However, these studies involve careful supervision and therapy for trial participants and exclude people at high risk of adverse outcomes.” Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.