Latest news with #PEX010
Yahoo
2 days ago
- Health
- Yahoo
FILAMENT HEALTH ANNOUNCES AUTHORIZATION OF PHASE 2 CLINICAL TRIAL STUDYING BOTANICAL PSILOCYBIN FOR PROLONGED GRIEF DISORDER
The clinical trial at Linkoping University will study Filament's botanical psilocybin drug candidate, PEX010 VANCOUVER, BC, June 11, 2025 /CNW/ - Filament Health Corp. (OTC: FLHLF) ("Filament" or the "Company"), a clinical‐stage natural psychedelic drug development company, today announced that the Swedish Ethical Review Authority and the Swedish Medical Products Agency have authorized a double-blind phase 2 clinical trial studying its botanical psilocybin drug candidate, PEX010, at Linkoping University. The trial will be the first to study the effects of psilocybin in the treatment of prolonged grief disorder. "In an aging society where people may outlive their family members by decades, it is crucial to develop treatment options for those with prolonged grief disorder," said Dr. Rebecca Böhme, Associate Professor at the Linkoping Center for Social and Affective Neuroscience. "This trial will assess whether psilocybin can improve adaptation to the loss experience. We are grateful to Filament Health for facilitating this research." People with prolonged grief disorder are at a 20 percent increased mortality risk. Previous psychological research suggests that the loss of a close person affects self-identity, an aspect of the higher cognitive self. Psilocybin is suggested to cause a transient shift from reliance on prior experiences towards current sensations. The clinical trial at Linkoping University will utilize this shift combined with a self-touch intervention to support re-learning about the bodily self in a trial population of 120 individuals. "We're pleased to provide PEX010 to Linkoping University for this much-needed area of research," said Benjamin Lightburn, Co-Founder and Chief Executive Officer at Filament Health. "This will be the ninth European clinical trial to study our drug candidate, positioning Filament as the region's leading supplier of GMP psilocybin." The trial at Linkoping University is expected to begin dosing in Q3 2025. PEX010 is authorized for investigation in 52 clinical trials worldwide for 14 mental health indications. ABOUT FILAMENT HEALTH (OTC:FLHLF)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 and on Twitter, Instagram, and LinkedIn. FORWARD LOOKING INFORMATIONCertain 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. SOURCE Filament Health Corp. View original content to download multimedia: Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Cision Canada
2 days ago
- Health
- Cision Canada
FILAMENT HEALTH ANNOUNCES AUTHORIZATION OF PHASE 2 CLINICAL TRIAL STUDYING BOTANICAL PSILOCYBIN FOR PROLONGED GRIEF DISORDER
The clinical trial at Linkoping University will study Filament's botanical psilocybin drug candidate, PEX010 VANCOUVER, BC, June 11, 2025 /CNW/ - Filament Health Corp. (OTC: FLHLF) (" Filament" or the " Company"), a clinical‐stage natural psychedelic drug development company, today announced that the Swedish Ethical Review Authority and the Swedish Medical Products Agency have authorized a double-blind phase 2 clinical trial studying its botanical psilocybin drug candidate, PEX010, at Linkoping University. The trial will be the first to study the effects of psilocybin in the treatment of prolonged grief disorder. "In an aging society where people may outlive their family members by decades, it is crucial to develop treatment options for those with prolonged grief disorder," said Dr. Rebecca Böhme, Associate Professor at the Linkoping Center for Social and Affective Neuroscience. "This trial will assess whether psilocybin can improve adaptation to the loss experience. We are grateful to Filament Health for facilitating this research." People with prolonged grief disorder are at a 20 percent increased mortality risk. Previous psychological research suggests that the loss of a close person affects self-identity, an aspect of the higher cognitive self. Psilocybin is suggested to cause a transient shift from reliance on prior experiences towards current sensations. The clinical trial at Linkoping University will utilize this shift combined with a self-touch intervention to support re-learning about the bodily self in a trial population of 120 individuals. "We're pleased to provide PEX010 to Linkoping University for this much-needed area of research," said Benjamin Lightburn, Co-Founder and Chief Executive Officer at Filament Health. "This will be the ninth European clinical trial to study our drug candidate, positioning Filament as the region's leading supplier of GMP psilocybin." The trial at Linkoping University is expected to begin dosing in Q3 2025. PEX010 is authorized for investigation in 52 clinical trials worldwide for 14 mental health indications. ABOUT FILAMENT HEALTH (OTC:FLHLF) 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 and on Twitter, Instagram, and LinkedIn. FORWARD LOOKING INFORMATION 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.
Yahoo
2 days ago
- Health
- Yahoo
FILAMENT HEALTH ANNOUNCES AUTHORIZATION OF PHASE 2 CLINICAL TRIAL STUDYING BOTANICAL PSILOCYBIN FOR PROLONGED GRIEF DISORDER
The clinical trial at Linkoping University will study Filament's botanical psilocybin drug candidate, PEX010 VANCOUVER, BC, June 11, 2025 /CNW/ - Filament Health Corp. (OTC: FLHLF) ("Filament" or the "Company"), a clinical‐stage natural psychedelic drug development company, today announced that the Swedish Ethical Review Authority and the Swedish Medical Products Agency have authorized a double-blind phase 2 clinical trial studying its botanical psilocybin drug candidate, PEX010, at Linkoping University. The trial will be the first to study the effects of psilocybin in the treatment of prolonged grief disorder. "In an aging society where people may outlive their family members by decades, it is crucial to develop treatment options for those with prolonged grief disorder," said Dr. Rebecca Böhme, Associate Professor at the Linkoping Center for Social and Affective Neuroscience. "This trial will assess whether psilocybin can improve adaptation to the loss experience. We are grateful to Filament Health for facilitating this research." People with prolonged grief disorder are at a 20 percent increased mortality risk. Previous psychological research suggests that the loss of a close person affects self-identity, an aspect of the higher cognitive self. Psilocybin is suggested to cause a transient shift from reliance on prior experiences towards current sensations. The clinical trial at Linkoping University will utilize this shift combined with a self-touch intervention to support re-learning about the bodily self in a trial population of 120 individuals. "We're pleased to provide PEX010 to Linkoping University for this much-needed area of research," said Benjamin Lightburn, Co-Founder and Chief Executive Officer at Filament Health. "This will be the ninth European clinical trial to study our drug candidate, positioning Filament as the region's leading supplier of GMP psilocybin." The trial at Linkoping University is expected to begin dosing in Q3 2025. PEX010 is authorized for investigation in 52 clinical trials worldwide for 14 mental health indications. ABOUT FILAMENT HEALTH (OTC:FLHLF)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 and on Twitter, Instagram, and LinkedIn. FORWARD LOOKING INFORMATIONCertain 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. SOURCE Filament Health Corp. View original content to download multimedia: Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Cision Canada
08-05-2025
- Business
- Cision Canada
FILAMENT HEALTH ANNOUNCES FIRST QUARTER 2025 FINANCIAL RESULTS AND OPERATIONAL HIGHLIGHTS
VANCOUVER, BC, /CNW/ - Filament Health Corp. (OTCQB: FLHLF) (CBOE: FH) (FSE: 7QS) ("Filament" or the "Company"), a clinical-stage natural psychedelic drug development company, released its first quarter financial results and operational highlights for the period ended March 31, 2025. "This quarter we were pleased to see positive data from a clinical trial studying our botanical psilocybin drug candidate, PEX010, for alcohol use disorder at Psychiatric Centre Copenhagen, among other notable operational developments," said Benjamin Lightburn, Co-Founder and Chief Executive Officer at Filament Health. "We were also encouraged by the successful completion of a meaningful fundraising round. This progress demonstrates our team's resilience and commitment to advancing our mission." Recent and Q1 2025 Financial and Operational Highlights: On April 9, 2025, the Company announced FDA authorization of a phase 2 clinical trial studying PEX010, the Company's botanical psilocybin drug candidate, for the treatment of opioid use disorder at the University of Pennsylvania. On April 9, 2025, the Company closed a financing of $960,000 further to the issuance of units, comprised of a secured convertible debenture of the company and a warrant. On March 17, 2025, the Company announced that a licensing partner studying the effects of its botanical psilocybin drug candidate, PEX010, for the treatment of alcohol use disorder ("AUD") produced positive data and results were published in the Journal of Psychopharmacology noting the safety and efficacy in reducing alcohol consumption in AUD patients. On January 21, 2025, the Company announced the shipment of botanical psilocybin to The University of Wisconsin-Madison for investigation in two US Food and Drug Administration-approved clinical trials studying the effects of psilocybin on neuroplasticity. Cash and cash equivalents of $130,441 as of March 31, 2025; Cash used in operating activities of $221,755 and total revenues of $103,480. Special Shareholder Meeting At a special shareholder meeting held on May 6, 2025, 99.625 percent of votes were cast in favour of the voluntary de-listing of the company's common shares from Cboe Canada. This strong support reflects shareholder alignment with the company's strategic direction and ongoing efforts to reduce operating costs. The Company is in active discussions with CBOE Canada regarding the de-listing and will share more information, such as when the Company's shares will be de-listed, as it becomes available. 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 and on Twitter, Instagram and LinkedIn. 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. Forward-looking statements herein include, but are not limited to, statements regarding the benefits of psilocin as compared to psilocybin. 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 results of the clinical trial. 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. SOURCE Filament Health Corp.
Yahoo
17-03-2025
- Health
- Yahoo
FILAMENT HEALTH ANNOUNCES POSITIVE DATA FROM PHASE 2 STUDY OF PEX010 IN PATIENTS WITH ALCOHOL USE DISORDER
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, BC, March 17, 2025 /CNW/ - Filament Health Corp. (OTCQB: FLHLF) (NEO: 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. 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 and on Twitter, Instagram, and LinkedIn. FORWARD LOOKING INFORMATIONCertain 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. SOURCE Filament Health Corp. View original content to download multimedia: Sign in to access your portfolio
