Enveric Biosciences Provides Strategic Outlook and Pipeline Update, Elevating EB-003 to Lead Development Candidate

Rhea-AI Summary

Enveric Biosciences (NASDAQ: ENVB) has announced that it is prioritizing the development of its novel neuroplastogenic molecule, EB-003. EB-003 is designed to treat severe mental health disorders such as depression, anxiety, and addiction without causing the hallucinogenic effects often associated with psychedelic-based treatments. The company is advancing pre-clinical development and plans to meet with the FDA for a Pre-IND discussion in early 2025. EB-003 aims to overcome key issues identified by the FDA's advisory committee regarding hallucinogenic psychedelics, such as 'expectation bias' and the need for psychotherapy co-administration. Early data shows EB-003 can bind to the 5-HT2A receptor and induce neuroplasticity without significant hallucinogenic side effects in animal models, paving the way for further human clinical studies.

Positive

• EB-003 is being prioritized as a lead development candidate, indicating strategic focus.
• EB-003 targets severe mental health disorders without hallucinogenic effects, addressing a significant market need.
• Early data shows EB-003 can induce neuroplasticity without significant hallucinogenic side effects, enhancing its clinical trial potential.
• A pre-IND meeting with the FDA is planned for early 2025, suggesting regulatory progress.

Negative

• The development timeline extends to early 2025 before a pre-IND meeting, indicating a lengthy path to market.
• There are potential challenges in confirming animal model results in human trials, adding risk to development.

Insights

Medical Research Analyst

Enveric Biosciences' prioritization of EB-003, a non-hallucinogenic neuroplastogen, offers promising advances in treating severe mental health disorders. Neuroplasticity—the brain's ability to reorganize itself by forming new neural connections—is important in addressing conditions like depression, anxiety and addiction. By avoiding the hallucinations common with psychedelic therapies, EB-003 could offer a more acceptable and accessible treatment option for patients.

The pre-clinical data on EB-003 indicates it binds to the 5-HT2A receptor, pivotal for neuroplastic effects, but without causing the head twitch response in mice, a predictor of hallucinogenic effects in humans. This could potentially enable wider adoption and more straightforward placebo-controlled trials.

In the short term, retail investors should note that the drug is still in pre-clinical stages, with an FDA meeting targeted for early 2025. Longer-term implications could be significant if clinical trials confirm the pre-clinical findings, leading to a first-in-class therapeutic for mental health without the need for psychotherapy and with outpatient feasibility.

Market Research Analyst

The mental health treatment market is projected to grow substantially, driven by increasing awareness and demand for effective treatments for depression, anxiety and addiction. Enveric Biosciences' EB-003, with its unique non-hallucinogenic profile, positions the company in a favorable spot within this rapidly expanding market.

The strategic elevation of EB-003 aligns with an increasing industry focus on neuroplasticity and novel treatment mechanisms. By addressing issues highlighted in FDA advisory committee discussions—such as expectation bias and the need for blinded trials—EB-003 may offer a competitive advantage over current psychedelic therapies. This could prove advantageous in market penetration and acceptance among healthcare providers and patients.

For retail investors, the potential for first-mover advantage in a burgeoning sector of the biotech industry is noteworthy. However, it's essential to consider the typical risks associated with early-stage biotech investments, including regulatory hurdles and the inherent uncertainty of clinical trial outcomes.

Financial Analyst

From a financial perspective, the strategic focus on EB-003 could significantly impact Enveric Biosciences' valuation. The market typically reacts positively to advancements in drug development pipelines, especially when targeting high-burden conditions like mental health disorders. The absence of hallucinogenic side effects in EB-003 provides a unique selling point that could attract both investors and partners.

In the short term, investors should monitor cost structures related to pre-clinical and clinical development, as these could affect cash flow and funding requirements. The company's ability to secure partnerships or funding will be important to advancing EB-003.

Looking long-term, successful FDA engagement and positive clinical trial results could substantially enhance Enveric's market position and open up revenue streams. However, investors should remain cautious of the high risk and volatility inherent in biotech stocks, particularly those in early development stages.

EB-003 is a novel, neuroplastogenic molecule designed to treat severe mental health disorders without the hallucinogenic effect typically associated with psychedelic-based compounds

Enveric is advancing pre-clinical development of EB-003 with a pre-IND meeting targeted for early 2025

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 depression, anxiety, and addiction disorders, today announced the Company is prioritizing the development of EB-003, its first-in-class approach to address difficult-to-treat mental health disorders. EB-003 and other neuroplastogens developed by Enveric are designed to promote neuroplasticity without inducing hallucinations, a hallmark side effect of many psychedelic and psychedelic-inspired compounds. Enveric is currently advancing pre-clinical development activities for EB-003 and targeting a Pre-IND meeting with the U.S. Food and Drug Administration (FDA) for early 2025.

“EB-003 has the potential to be a breakthrough neuroplastogen drug candidate that offers the ability to treat resistant mental health disorders without the hallucinogenic effect typically associated with psychedelic-based molecules,” said Joseph Tucker, Ph.D., Director and CEO of Enveric. “Minimizing the hallucinatory effect is vital for the clinical development of EB-003 since it will allow for truly blinded placebo-controlled clinical trials and eliminate the need for co-administration of psychotherapy. In addition, minimizing the hallucinatory effect will enable the administration of such therapies in an outpatient setting, and support a more widespread acceptance for psychedelic-inspired drugs.”

Dr. Tucker continued, “The potential advantages of EB-003 were underscored during the recent U.S. FDA Psychopharmacologic Drugs Advisory Committee for Lykos Therapeutics’ MDMA-assisted therapy (Lykos Adcom). During the Lykos Adcom meeting, the advisory committee raised several issues that likely will need to be overcome by hallucination-inducing psychedelics currently in development. Notably, ‘expectation bias’ and the inability to adequately blind both patients and study monitors due to the psychedelic properties of the Lykos candidate decreased reviewer confidence in the efficacy data reported from the studies. Reviewers also questioned the relative contributions of the pharmacological treatment versus the supportive psychotherapy to the reported outcomes and expressed concerns regarding the lack of standardization of the psychotherapy. Enveric believes EB-003 is uniquely designed to address these valid concerns of the Advisory Committee and accordingly have determined to elevate EB-003 to be our lead development candidate to accelerate our plans to advance it to human clinical studies.”

Dr. Tucker concluded, “Data produced thus far has demonstrated EB-003’s ability to bind to the 5-HT2A receptor and induce neuroplasticity while eliciting no significant head twitch response in mice, a behavioral model used to predict the likelihood of a molecule to produce hallucinogenic effects in humans. Confirming this observation in humans will be a top priority in designing the EB-003 clinical program."

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 program, EB-003, is a first-in-class approach to the treatment of difficult-to-address mental health disorders designed to promote neuroplasticity without inducing hallucinations in the patient. Enveric is also developing EB-002, formerly EB-373, a next generation synthetic prodrug of the active metabolite, psilocin, being studied as a treatment of psychiatric disorders. 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,” “proposed,” “budgets,” “explores,” “scheduled,” “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: negotiate and finalize definitive agreements based on any of its out-licensing term sheets and for licensees to perform pursuant to the terms thereof; carry out successful clinical programs in Australia; 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 businesswire.com: https://www.businesswire.com/news/home/20240625428098/en/

Investor Relations

Tiberend Strategic Advisors, Inc.

Daniel Kontoh-Boateng

(862) 213-1398

dboateng@tiberend.com

Media Relations

Tiberend Strategic Advisors, Inc.

Casey McDonald

(646) 577-8520

cmcdonald@tiberend.com

Source: Enveric Biosciences

FAQ

What is EB-003, and how does it relate to ENVB?

EB-003 is a novel neuroplastogenic molecule developed by Enveric Biosciences (NASDAQ: ENVB) to treat severe mental health disorders without causing hallucinogenic effects.

When does Enveric plan to hold a Pre-IND meeting for EB-003?

Enveric Biosciences plans to hold a Pre-IND meeting with the FDA for EB-003 in early 2025.

What differentiates EB-003 from other psychedelics?

EB-003 is designed to induce neuroplasticity without causing hallucinogenic effects, unlike traditional psychedelics.

What are the key issues EB-003 aims to address?

EB-003 aims to address 'expectation bias' and the need for psychotherapy co-administration, which are concerns with current hallucinogenic psychedelics.

What early data supports the development of EB-003?

Early data shows that EB-003 can bind to the 5-HT2A receptor and induce neuroplasticity without significant hallucinogenic side effects in animal models.