Enveric Biosciences Preclinical Pharmacokinetic Studies of EB-003 Support Oral Bioavailability, Demonstrate Brain Penetration, and Show No Evidence of Hallucination-like Behavior

Rhea-AI Summary

Enveric Biosciences (NASDAQ: ENVB) announced positive results from preclinical pharmacokinetic studies of EB-003, demonstrating favorable oral bioavailability and brain penetration without hallucination-like behavior in rat and dog models. The studies showed dose-proportional oral bioavailability and a significant brain/plasma ratio of 5-6 in rats, higher than previously observed in mice (~1.5). No clinical signs of hallucination were observed in either species. The company plans to submit an Investigational New Drug (IND) application to the FDA in the second half of 2025 for this potential treatment of depression, anxiety, and other psychiatric disorders.

Positive

• Successful demonstration of oral bioavailability in multiple animal models
• Higher brain penetration ratio (5-6x) compared to previous mouse studies (1.5x)
• No hallucination-related side effects observed in animal studies
• Potential market opportunity exceeding $35 billion by 2030

Negative

• IND application submission not planned until second half of 2025
• Early-stage development with no human clinical data yet

Insights

Medical Research Analyst

<p>The preclinical PK studies for EB-003 reveal several promising characteristics that strengthen its development potential. The <b>dose-proportional oral bioavailability</b> across multiple species (rat, dog and previously mouse) suggests consistent drug absorption and metabolism, which is important for reliable dosing in humans. The <b>brain/plasma ratio of 5-6</b> in rats is particularly noteworthy, as it indicates superior brain penetration compared to previous mouse studies.</p><p>The absence of hallucination-associated behaviors and the enhanced brain penetration could translate to a favorable therapeutic window - potentially allowing for lower doses while maintaining efficacy. This profile aligns with the growing demand for non-hallucinogenic neuroplastogens in treating psychiatric disorders. The <money>$35 billion</money> market opportunity by <b>2030</b> reflects the significant unmet need in mental health treatment, particularly given the <percent>50%</percent> of patients who don't respond adequately to current treatments.</p>

Dose-proportional oral bioavailability without clinical signs, including those associated with hallucinogenic compounds, was demonstrated in rat and dog pharmacokinetic (PK) studies while significant brain penetration was observed in rat

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Enveric Biosciences, Inc. (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel neuroplastogen small molecule therapeutics for the treatment of depression, anxiety, and other psychiatric disorders, today announced the completion of preclinical pharmacokinetic (“PK”) studies in rat and dog further supporting the oral bioavailability and targeted non-hallucinogenic profile of EB-003.

The PK studies demonstrated oral bioavailability in rat and dog studies that was dose-proportional, as was also shown previously in a mouse model. No clinical signs, including those associated with hallucination, were observed in either study. For example, in dogs, ataxia and vocalization were not observed.

Additionally, significant brain penetration was demonstrated in the rat model with a brain/plasma ratio of about 5-6, which is significantly higher than was seen in the mouse model (~1.5). This increased brain/plasma ratio could translate to enhanced efficacy, lower doses, and less off-target side effects if these findings are confirmed in clinical trials.

“Completion of these animal PK studies further supports our efforts to develop conveniently delivered, orally-available drugs with the potential to harness neuroplastic properties without inducing hallucinations,” said Joseph Tucker, Ph.D., CEO of Enveric. “The additional data gained in these animal studies enhances our understanding of the preclinical profile of this drug candidate and brings us a step closer to finalizing the data package for the EB-003 Investigational New Drug (IND) application, which we anticipate submitting to the U.S. Food and Drug Administration in the second half of 2025.”

“Mental health disorders like depression and anxiety are on the rise, with approximately one billion people globally expected to experience a neuropsychiatric disorder at some time in their lives¹. Despite the prevalence of these conditions, currently approved treatments fail to provide adequate relief for half of the patients who try them, resulting in widespread challenges to the psychiatric community². The market opportunity for neuroplastogens is estimated to exceed $35 billion by 2030, with the potential to offer low side-effects, strong efficacy, and potential synergies with current drugs, which could help drive demand for new and innovative treatment options³.”

1. World Health Organization, "Mental Health and Substance Use," accessed November 20 2024, https://www.cambridge.org/core/journals/epidemiology-and-psychiatric-sciences/article/changing-trends-in-the-global-burden-of-mental-disorders-from-1990-to-2019-and-predicted-levels-in-25-years/57DCF2F39E8DC9DD19250C1CE95C24F8?utm
2. David J. Kupfer et al., "Why Have Efforts to Find Biomarkers for Major Depressive Disorder Failed?," Molecular Psychiatry 17, no. 6 (2012): 569-583, https://pmc.ncbi.nlm.nih.gov/articles/PMC3736946/.
3. Coherent Market Insights, "Neuroplasticity Market Analysis," accessed November 20, 2024, https://www.coherentmarketinsights.com/market-insight/neuroplasticity-market-6032.
   

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 depression, anxiety, and addiction disorders. Leveraging its unique discovery and development platform, Psybrary™, Enveric has created a robust intellectual property portfolio of new chemical entities for specific mental health indications. 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 all other novel, patented Psybrary™ 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 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: successfully outlicense patented Psybrary^TM drug candidates to third-party licensees; negotiate and finalize definitive agreements based on any of its out-licensing term sheets and for licensees to perform pursuant to the terms thereof; 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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Investor Relations

Tiberend Strategic Advisors, Inc.

David Irish

(231) 632-0002

dirish@tiberend.com

Media Relations

Tiberend Strategic Advisors, Inc.

Casey McDonald

(646) 577-8520

cmcdonald@tiberend.com

Source: Enveric Biosciences, Inc.

FAQ

What were the key findings of Enveric Biosciences' (ENVB) EB-003 preclinical studies?

The studies demonstrated dose-proportional oral bioavailability, significant brain penetration with a brain/plasma ratio of 5-6 in rats, and showed no evidence of hallucination-like behavior in both rat and dog models.

When will Enveric Biosciences (ENVB) submit the IND application for EB-003?

Enveric Biosciences plans to submit the Investigational New Drug (IND) application for EB-003 to the FDA in the second half of 2025.

What is the market potential for Enveric Biosciences' (ENVB) neuroplastogen treatments?

The market opportunity for neuroplastogens is estimated to exceed $35 billion by 2030, targeting the treatment of depression, anxiety, and other psychiatric disorders.