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Data establish maximum tolerated dose, supporting progression of lead neuroplastogen compound EB-003 toward IND-enabling studies and First-in-Human clinical trials
Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company focused on developing novel neuroplastogenic small-molecule therapeutics for the treatment of depression, post-traumatic stress disorder (PTSD), and other neuropsychiatric disorders, today announced the successful completion of 7-day Dose Range Finding (DRF) toxicology studies in two preclinical species for its lead drug candidate, EB-003. The results define the Maximum Tolerated Dose (MTD) and represent a key pipeline advancement landmark supporting the Company's IND-enabling activities and preparation for First-in-Human clinical trials.
The DRF studies were designed to evaluate toxicity and toxicokinetics following daily oral dosing of EB-003, Enveric's first-in-class neuroplastogen candidate that selectively engages serotonin 5-HT 2A and 5-HT 1B receptors. The findings confirmed oral bioavailability in both species, with dose-dependent increases in plasma EB-003 concentrations observed across the tested range. At higher dose levels, central nervous system (CNS)-related effects were noted in both species, indicative of brain penetration and potential on-target activity. These results provide important safety and tolerability data to guide dosing strategies in future animal studies and First-in-Human studies.
"Completion of the DRF toxicology studies and establishment of the MTD in two preclinical species is a significant and necessary milestone in the development of EB-003," said Dr. Joseph Tucker, Chief Executive Officer of Enveric. "These findings provide a well-defined reference point for planning human dosing and position us to advance EB-003 into definitive toxicology, safety pharmacology, and genotoxicity studies required for the IND submission to the FDA. This achievement moves us closer to clinical trial readiness for EB-003."
Determining the MTD offers insight into the relationship between the anticipated therapeutic dose and toxic limits, a critical element in the regulatory pathway toward human testing. In addition, the reproducibility of CNS-related effects, and confirmation of oral bioavailability and brain penetration support the compound's intended use and inform the design of upcoming studies.
EB-003 is a first-in-class, neuroplastogen designed to selectively engage serotonin 5-HT 2A and 5-HT 1B receptors, targets implicated in neuroplasticity and mood regulation, without inducing hallucinations. Preclinical findings to date support the potential of EB-003 to promote adaptive neural circuit remodeling in animals without inducing motor responses predictive of hallucinogenic effects in humans. These pharmacological characteristics potentially enable outpatient administration for chronic neuropsychiatric indications. EB-003 is advancing through preclinical development toward evaluation in human clinical trials.
About Enveric Biosciences
Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company focused on developing next-generation, small-molecule neuroplastogenic therapeutics that address unmet needs in psychiatric and neurological disorders. By leveraging a differentiated drug discovery platform and a growing library of protected chemical structures, Enveric is advancing a pipeline of novel compounds designed to promote neuroplasticity without hallucinogenic effects. Enveric's lead candidate, EB-003, is the first known compound designed to selectively engage both 5-HT 2A and 5-HT 1B receptors to deliver fast-acting, durable antidepressant and anxiolytic effects with outpatient convenience.
For more information, please visit www.enveric.com .
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.
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