Latest news with #EB-003
Business Wire
15-07-2025
- Health
- Business Wire
Enveric Biosciences Lead Drug Candidate EB-003 Demonstrates Positive Effects in Preclinical Model of Post-Traumatic Stress Disorder (PTSD)
BUSINESS WIRE)-- Enveric Biosciences (NASDAQ: ENVB) ('Enveric' or the 'Company'), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of psychiatric and neurological disorders, today announced positive results in a preclinical, exposure-based therapeutic model for post-traumatic stress disorder (PTSD). In fear conditioned mice, oral administration of EB-003 significantly decreased context-induced freezing behavior when measured one-hour post-dose (p < 0.05) indicating a positive therapeutic effect with extinction of contextual fear after a single dose. These results were in line with the therapeutic effects observed with MDMA, which was used as a positive control in this study. MDMA is a psychedelic controlled substance that has demonstrated clinical benefit in the treatment of PTSD in human trials, although it is not approved by the FDA. The pairing of electrical shock stimulus with a controlled environment generates context-based traumatic memories leading to freezing behaviors when the subject is re-exposed to the same environment. This well-established translational rodent model, performed by a third-party lab, is designed to induce a potent, trauma-related state of fear using a Pavlovian association paradigm. 'Only a few medications have been approved by the FDA for the treatment of PTSD, including the serotonin reuptake inhibitors (SSRIs) paroxetine and sertraline,' said Joseph Tucker, Ph.D., CEO and Director of Enveric. 'Only 20% to 30% of PTSD patients experience full remission with these drugs and it takes two to three weeks of SSRI administration before clinical and neuronal benefits become apparent. Clearly, there is enormous unmet need in PTSD, which has yet to be addressed with meaningful innovation.' Dr. Tucker added: 'Research has implicated impaired hippocampal neuroplasticity as key underlying features of patients struggling with PTSD. We are very encouraged that a single dose of our lead neuroplastogen, EB-003, facilitated rapid fear extinction in mice.' In light of this new data, EB-003, a next-generation neuroplastogen that may enhance hippocampal neuroplasticity without causing hallucinations, has the potential to significantly improve treatment outcomes for this chronic and debilitating mental health condition, representing a major opportunity in an underserved market. About Enveric Biosciences Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of psychiatric and neurological disorders. Leveraging its unique discovery and development Psybrary™ platform, which houses proprietary information on the use and development of existing and novel molecules for specific mental health indications, Enveric seeks to develop a robust intellectual property portfolio of novel drug candidates. Enveric's lead molecule, EB-003, is a potential first-in-class neuroplastogen designed to promote neuroplasticity, without inducing hallucinations, in patients suffering from difficult-to-address mental health disorders. Enveric is focused on advancing EB-003 towards clinical trials for the treatment of neuropsychiatric disorders while out-licensing other novel, patented Psybrary™ platform drug candidates to third-party licensees advancing non-competitive market strategies for patient care. Enveric is headquartered in Naples, FL with offices in Cambridge, MA and Calgary, AB Canada. For more information, please visit Forward-Looking Statements This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as "plans," "expects" or "does not expect," "proposes," "budgets," "explores," "schedules," "seeks," "estimates," "forecasts," "intends," "anticipates" or "does not anticipate," or "believes," or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, should, would, or might occur or be achieved. Forward-looking statements may include statements regarding beliefs, plans, expectations, or intentions regarding the future and are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the ability of Enveric to: finalize and submit its IND filing to the U.S. Food and Drug Administration; carry out successful clinical programs; achieve the value creation contemplated by technical developments; avoid delays in planned clinical trials; establish that potential products are efficacious or safe in preclinical or clinical trials; establish or maintain collaborations for the development of therapeutic candidates; obtain appropriate or necessary governmental approvals to market potential products; obtain future funding for product development and working capital on commercially reasonable terms; scale-up manufacture of product candidates; respond to changes in the size and nature of competitors; hire and retain key executives and scientists; secure and enforce legal rights related to Enveric's products, including patent protection; identify and pursue alternative routes to capture value from its research and development pipeline assets; continue as a going concern; and manage its future growth effectively. A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric's filings with the Securities and Exchange Commission, including Enveric's Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Business Wire
24-06-2025
- Business
- Business Wire
Enveric Biosciences Announces Data that Broadens Scope of Clinical Indication Potential for Lead Candidate EB-003
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Enveric Biosciences (NASDAQ: ENVB) ('Enveric' or the 'Company'), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of psychiatric and neurological disorders, today unveiled additional data indicating that its lead development candidate, EB-003, acts as an agonist of the serotonin receptor 5-HT1B, in addition to its other previously disclosed receptor engagement activities. The 5-HT1B receptor is a recognized therapeutic target for treating several central nervous system ('CNS') conditions, including major depressive disorder, Parkinson's disease, migraines, and cluster headaches. The study results demonstrated agonism of 5-HT1B by EB-003 (EC 50 = 110 nM) and added to the existing receptor engagement data supporting that EB-003 acts as a partial agonist of the 5-HT2A receptor, which is key to the compound's potential ability to elicit neuroplastogenic effects without inducing adverse hallucinogenic outcomes. 'The 5-HT1B receptor, found predominantly in the frontal cortex, basal ganglia and hippocampus, is a validated therapeutic target of some well-known CNS drugs,' said Joseph Tucker, Ph.D., CEO of Enveric. 'Enveric previously announced positive pharmacology, in vitro safety and oral bioavailability data of EB-003, including achieving therapeutically relevant brain exposure in rodent models. The newly revealed ability to target 5-HT1B illustrates EB-003's differentiated and multifaceted mechanism of action and broadens its utility and the range of potential target indications to pursue in future development.' EB-003 is currently in preclinical development, with IND-enabling activities planned to continue through 2025. Enveric Biosciences will continue to explore strategic therapeutic opportunities in the psychiatric and neurological markets to strengthen the target product profile of this novel CNS drug candidate. About Enveric Biosciences Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of psychiatric and neurological disorders. Leveraging its unique discovery and development Psybrary™ platform, which houses proprietary information on the use and development of existing and novel molecules for specific mental health indications, Enveric seeks to develop a robust intellectual property portfolio of novel drug candidates. Enveric's lead molecule, EB-003, is a potential first-in-class neuroplastogen designed to promote neuroplasticity, without inducing hallucinations, in patients suffering from difficult-to-address mental health disorders. Enveric is focused on advancing EB-003 towards clinical trials for the treatment of neuropsychiatric disorders while out-licensing other novel, patented Psybrary™ platform drug candidates to third-party licensees advancing non-competitive market strategies for patient care. Enveric is headquartered in Naples, FL with offices in Cambridge, MA and Calgary, AB Canada. For more information, please visit Forward-Looking Statements This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as "plans," "expects" or "does not expect," "proposes," "budgets," "explores," "schedules," "seeks," "estimates," "forecasts," "intends," "anticipates" or "does not anticipate," or "believes," or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, should, would, or might occur or be achieved. Forward-looking statements may include statements regarding beliefs, plans, expectations, or intentions regarding the future and are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the ability of Enveric to: finalize and submit its IND filing to the U.S. Food and Drug Administration; carry out successful clinical programs; achieve the value creation contemplated by technical developments; avoid delays in planned clinical trials; establish that potential products are efficacious or safe in preclinical or clinical trials; establish or maintain collaborations for the development of therapeutic candidates; obtain appropriate or necessary governmental approvals to market potential products; obtain future funding for product development and working capital on commercially reasonable terms; scale-up manufacture of product candidates; respond to changes in the size and nature of competitors; hire and retain key executives and scientists; secure and enforce legal rights related to Enveric's products, including patent protection; identify and pursue alternative routes to capture value from its research and development pipeline assets; continue as a going concern; and manage its future growth effectively. A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric's filings with the Securities and Exchange Commission, including Enveric's Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Yahoo
29-05-2025
- Business
- Yahoo
Enveric Biosciences announces results from EB-003 trial
Enveric Biosciences (ENVB) announced preclinical results for its lead neuroplastogen drug candidate, EB-003, in the Open Space Forced Swim Test, a preclinical mouse model of severe depression and despair. The Open Space Forced Swim Test, a psychiatric behavioral model, is designed to induce potent and enduring chronic depression-like states in mice, leading to reduced swim distance and increased periods of despair-induced immobility. In a study performed by a third-party lab, an oral dose of EB-003 at 30 mg/kg significantly reduced depression-like behavior within 30 minutes of administration. This was indicated by the enhanced distance travelled and reduced immobility of treated mice during forced swim sessions. These results were comparable to the therapeutic effects of Imipramine, an approved tricyclic antidepressant drug. A repeat study, conducted by the same third-party lab, produced consistent results, confirming 30 mg/kg as an efficacious oral dose for EB-003. The study also confirmed no adverse locomotor effects were observed at this dose. The study also performed a preliminary assessment of extended, daily dosing of EB-003 to determine any potential safety concerns for chronic therapeutic administration. Mice receiving a daily oral dose of EB-003 at 30 mg/kg for 22 days showed no adverse behavioral, physiological or neurological effects. These observations demonstrate acceptable tolerance to long-term systemic drug exposure and expand the range of EB-003 dosing strategies. Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See Insiders' Hot Stocks on TipRanks >> Read More on ENVB: Disclaimer & DisclosureReport an Issue Psychedelic: atai Life Sciences reports Phase 2a study data on BPL-003 Enveric Biosciences files new provisional patent application VA secretary wants to find answers on psychedelics therapies, Politico says Psychedelic: Atai, Enveric, Incannex and Relmada report quarterly results Psychedelic: Enveric, Filament Health report earnings results
Yahoo
28-05-2025
- Business
- Yahoo
Enveric Biosciences Reports Positive Preclinical Results for Lead Drug Candidate EB-003
Statistically significant improvements in a preclinical model of severe chronic depression and despair Support for safe, extended, daily oral administration CAMBRIDGE, Mass., May 28, 2025--(BUSINESS WIRE)--Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of psychiatric and neurological disorders, today announced positive preclinical results for its lead neuroplastogen drug candidate, EB-003, in the Open Space Forced Swim Test, a preclinical mouse model of severe depression and despair. The Open Space Forced Swim Test, a well-established psychiatric behavioral model, is designed to induce potent and enduring chronic depression-like states in mice, leading to reduced swim distance and increased periods of despair-induced immobility. In a study performed by a third-party lab, an oral dose of EB-003 at 30 mg/kg significantly reduced depression-like behavior within 30 minutes of administration. This was indicated by the enhanced distance travelled and reduced immobility of treated mice during forced swim sessions (statistical p-value < 0.01). These results were comparable to the therapeutic effects of Imipramine, an approved tricyclic antidepressant drug. A repeat study, conducted by the same third-party lab, produced consistent results, confirming 30 mg/kg as an efficacious oral dose for EB-003. The study also confirmed no adverse locomotor effects were observed at this dose. The study also performed a preliminary assessment of extended, daily dosing of EB-003 to determine any potential safety concerns for chronic therapeutic administration. Mice receiving a daily oral dose of EB-003 at 30 mg/kg for 22 days showed no adverse behavioral, physiological or neurological effects. These observations demonstrate acceptable tolerance to long-term systemic drug exposure and expand the range of EB-003 dosing strategies. "We are encouraged by these statistically significant and biologically meaningful results in a severe chronic depression animal model," said Dr. Joseph Tucker, CEO of Enveric Biosciences. "EB-003 has now demonstrated strong behavioral efficacy and a clean safety profile in several animal models that are relevant to chronic treatment of severe depression. These data points validate the compound's pharmacological design and provide strong support for the planned Investigational New Drug (IND) application" EB-003 is the lead compound from Enveric's proprietary EVM301 Series, a pipeline of next-generation neuroplastogens engineered to stimulate synaptic plasticity without incurring hallucinogenic liability. About Enveric Biosciences Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of psychiatric and neurological disorders. Leveraging its unique discovery and development platform Psybrary™, which houses proprietary information on the use and development of existing and novel molecules for specific mental health indications, Enveric seeks to develop a robust intellectual property portfolio of novel drug candidates. Enveric's lead molecule, EB-003, is a potential first-in-class neuroplastogen designed to promote neuroplasticity, without inducing hallucinations, in patients suffering from difficult-to-address mental health disorders. Enveric is focused on advancing EB-003 towards clinical trials for the treatment of neuropsychiatric disorders while out-licensing other novel, patented Psybrary™ platform drug candidates to third-party licensees advancing non-competitive market strategies for patient care. Enveric is headquartered in Naples, FL with offices in Cambridge, MA and Calgary, AB Canada. For more information, please visit Forward-Looking Statements This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as "plans," "expects" or "does not expect," "proposes," "budgets," "explores," "schedules," "seeks," "estimates," "forecasts," "intends," "anticipates" or "does not anticipate," or "believes," or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, should, would, or might occur or be achieved. Forward-looking statements may include statements regarding beliefs, plans, expectations, or intentions regarding the future and are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the ability of Enveric to: finalize and submit its IND filing to the U.S. Food and Drug Administration; carry out successful clinical programs; achieve the value creation contemplated by technical developments; avoid delays in planned clinical trials; establish that potential products are efficacious or safe in preclinical or clinical trials; establish or maintain collaborations for the development of therapeutic candidates; obtain appropriate or necessary governmental approvals to market potential products; obtain future funding for product development and working capital on commercially reasonable terms; scale-up manufacture of product candidates; respond to changes in the size and nature of competitors; hire and retain key executives and scientists; secure and enforce legal rights related to Enveric's products, including patent protection; identify and pursue alternative routes to capture value from its research and development pipeline assets; continue as a going concern; and manage its future growth effectively. A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric's filings with the Securities and Exchange Commission, including Enveric's Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. View source version on Contacts Investor RelationsTiberend Strategic Advisors, Inc. David Irish(231) 632-0002dirish@ Media RelationsTiberend Strategic Advisors, Inc. Casey McDonald(646) 577-8520cmcdonald@ Sign in to access your portfolio
Business Wire
28-05-2025
- Health
- Business Wire
Enveric Biosciences Reports Positive Preclinical Results for Lead Drug Candidate EB-003
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Enveric Biosciences (NASDAQ: ENVB) ('Enveric' or the 'Company'), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of psychiatric and neurological disorders, today announced positive preclinical results for its lead neuroplastogen drug candidate, EB-003, in the Open Space Forced Swim Test, a preclinical mouse model of severe depression and despair. The Open Space Forced Swim Test, a well-established psychiatric behavioral model, is designed to induce potent and enduring chronic depression-like states in mice, leading to reduced swim distance and increased periods of despair-induced immobility. In a study performed by a third-party lab, an oral dose of EB-003 at 30 mg/kg significantly reduced depression-like behavior within 30 minutes of administration. This was indicated by the enhanced distance travelled and reduced immobility of treated mice during forced swim sessions (statistical p-value < 0.01). These results were comparable to the therapeutic effects of Imipramine, an approved tricyclic antidepressant drug. A repeat study, conducted by the same third-party lab, produced consistent results, confirming 30 mg/kg as an efficacious oral dose for EB-003. The study also confirmed no adverse locomotor effects were observed at this dose. The study also performed a preliminary assessment of extended, daily dosing of EB-003 to determine any potential safety concerns for chronic therapeutic administration. Mice receiving a daily oral dose of EB-003 at 30 mg/kg for 22 days showed no adverse behavioral, physiological or neurological effects. These observations demonstrate acceptable tolerance to long-term systemic drug exposure and expand the range of EB-003 dosing strategies. 'We are encouraged by these statistically significant and biologically meaningful results in a severe chronic depression animal model,' said Dr. Joseph Tucker, CEO of Enveric Biosciences. 'EB-003 has now demonstrated strong behavioral efficacy and a clean safety profile in several animal models that are relevant to chronic treatment of severe depression. These data points validate the compound's pharmacological design and provide strong support for the planned Investigational New Drug (IND) application' EB-003 is the lead compound from Enveric's proprietary EVM301 Series, a pipeline of next-generation neuroplastogens engineered to stimulate synaptic plasticity without incurring hallucinogenic liability. About Enveric Biosciences Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of psychiatric and neurological disorders. Leveraging its unique discovery and development platform Psybrary™, which houses proprietary information on the use and development of existing and novel molecules for specific mental health indications, Enveric seeks to develop a robust intellectual property portfolio of novel drug candidates. Enveric's lead molecule, EB-003, is a potential first-in-class neuroplastogen designed to promote neuroplasticity, without inducing hallucinations, in patients suffering from difficult-to-address mental health disorders. Enveric is focused on advancing EB-003 towards clinical trials for the treatment of neuropsychiatric disorders while out-licensing other novel, patented Psybrary™ platform drug candidates to third-party licensees advancing non-competitive market strategies for patient care. Enveric is headquartered in Naples, FL with offices in Cambridge, MA and Calgary, AB Canada. For more information, please visit Forward-Looking Statements This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as "plans," "expects" or "does not expect," "proposes," "budgets," "explores," "schedules," "seeks," "estimates," "forecasts," "intends," "anticipates" or "does not anticipate," or "believes," or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, should, would, or might occur or be achieved. Forward-looking statements may include statements regarding beliefs, plans, expectations, or intentions regarding the future and are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the ability of Enveric to: finalize and submit its IND filing to the U.S. Food and Drug Administration; carry out successful clinical programs; achieve the value creation contemplated by technical developments; avoid delays in planned clinical trials; establish that potential products are efficacious or safe in preclinical or clinical trials; establish or maintain collaborations for the development of therapeutic candidates; obtain appropriate or necessary governmental approvals to market potential products; obtain future funding for product development and working capital on commercially reasonable terms; scale-up manufacture of product candidates; respond to changes in the size and nature of competitors; hire and retain key executives and scientists; secure and enforce legal rights related to Enveric's products, including patent protection; identify and pursue alternative routes to capture value from its research and development pipeline assets; continue as a going concern; and manage its future growth effectively. A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric's filings with the Securities and Exchange Commission, including Enveric's Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
