Enveric Biosciences Announces Positive Pharmacology and Safety Data for Lead Product, EB-003

Rhea-AI Summary

Enveric Biosciences (NASDAQ: ENVB) has announced positive results from preclinical safety and pharmacology studies for its lead drug candidate, EB-003. The in vitro studies confirmed EB-003's selective activity with desired serotonergic neuroreceptors and showed a low potential for undesirable cardiovascular, respiratory, and neurological reactions or drug-to-drug interactions.

Key findings include:

• No significant off-target interactions detected
• No meaningful activity against hERG or 5-HT2B, targets related to cardiovascular adverse drug reactions
• No activity against the M1 muscarinic acetylcholine receptor, related to CNS adverse drug reactions

These results, combined with previously reported antidepressant, anxiolytic, and neuroplastogenic properties in animal models, enhance confidence in EB-003's potential. Enveric plans to begin in vivo toxicology and safety pharmacology activities in Q4 2024, with an expected IND application filing by Q3 2025 and clinical development initiation by the end of 2025.

Positive

• Positive preclinical safety and pharmacology study results for lead drug candidate EB-003
• Low potential for undesirable cardiovascular, respiratory, and neurological reactions
• No significant off-target interactions detected in in vitro studies
• Previously reported antidepressant, anxiolytic, and neuroplastogenic properties in animal models
• Oral bioavailability and ability to produce brain exposure at therapeutically relevant levels confirmed

Negative

• None.

Insights

Neuropharmacologist

The preclinical data for EB-003 is promising, showing selective targeting of serotonergic receptors without significant off-target effects. This is important for developing neuroplastogenic therapeutics with potentially fewer side effects than current antidepressants. The lack of interaction with hERG, 5-HT2B and M1 muscarinic receptors is particularly noteworthy, as it suggests a reduced risk of cardiovascular and CNS adverse events.

However, it's important to note that while in vitro results are encouraging, they don't guarantee in vivo efficacy or safety. The planned in vivo toxicology studies in Q4 2024 will be critical. If these studies corroborate the in vitro findings, EB-003 could represent a significant advancement in treating depression, anxiety and addiction disorders. The projected IND filing in Q3 2025 and clinical trials by end of 2025 provide a clear development timeline for investors to monitor.

Biotech Investment Analyst

For a small-cap biotech like Enveric ($3.7M market cap), positive preclinical data is a significant milestone. The safety profile of EB-003 addresses key concerns in CNS drug development, potentially differentiating it from existing treatments. This could attract partnership interest or increase the company's value proposition.

However, investors should consider:

• The long timeline to clinical trials (end of 2025) means significant cash burn ahead
• Preclinical success doesn't guarantee clinical efficacy
• The company's small market cap suggests high risk and potential for dilution

While the news is positive, Enveric needs to maintain a strong cash position to reach clinical stage. Investors should closely monitor the company's financial health and any potential partnerships or funding rounds in the coming years.

• In vitro pharmacology studies confirmed EB-003’s ability to target desired serotonergic receptors, supporting the potential of the neuroplastogenic therapeutic candidate to address difficult-to-treat mental health disorders without inducing hallucinations

• Analysis of off-target interactions indicate ability of EB-003 to minimize potential adverse cardiovascular and CNS events that are common to serotonin-like drug compounds

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 positive results for preclinical safety and pharmacology studies, which evaluated off-target interactions of its lead drug candidate, EB-003, and confirmed selective activity with desired serotonergic neuroreceptors.

The in vitro pharmacological studies, which profiled EB-003 against a broad range of secondary targets (receptors, ion channels, enzymes and transporters), showed a low potential to induce undesirable cardiovascular, respiratory, and neurological reactions, or to have drug-to-drug interactions.

Results of this large in vitro screen suggest a favorable safety profile for EB-003 with no significant off-target interactions detected. Notably, EB-003 showed no meaningful activity against hERG or 5-HT2B, targets related to cardiovascular adverse drug reactions (ADRs). Drug interaction with hERG can elicit fatal cardiac arrhythmias, while off-target activation of the serotonin receptor 5-HT2B located in cardiac tissues is known to induce pulmonary hypertension and serious valvular heart disease. Several approved antidepressants and neuroactive drugs have seen reduced use and/or have been removed from the market based on interactions with these receptors, and the harmful downstream impacts on patient safety.

Additionally, EB-003 showed no activity against the M1 muscarinic acetylcholine receptor (mAChR), a target related to central nervous system (CNS) ADRs. mAChR is involved in regulating perception, attention, and cognitive function with the potential to provoke severe drug-induced-delirium.

Joseph Tucker, Ph.D., Director and CEO of Enveric, commented, “From our perspective, positive results from this key in vitro safety screen further derisk EB-003. These results, along with previously reported antidepressant, anxiolytic, and neuroplastogenic properties in animal models, enhance our confidence in this lead compound. We are excited to progress EB-003 through the final steps of the Company’s Investigational New Drug (IND) application, including in vivo toxicology and safety pharmacology activities, all scheduled to begin in Q4 of 2024.”

Enveric recently announced preclinical data confirming the oral bioavailability of EB-003 and its ability to produce brain exposure at therapeutically relevant levels. Enveric expects to file an IND application for EB-003 by the third quarter of 2025 and initiate clinical development by the end of 2025.

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, a next generation synthetic prodrug of the active metabolite, psilocin, being studied as a treatment for 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,” “proposes,” “ “budgets,” “schedules,” “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 perform pursuant to the terms thereof; 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

FAQ

What are the key findings from Enveric Biosciences' preclinical studies on EB-003?

Enveric Biosciences' preclinical studies on EB-003 showed selective activity with desired serotonergic neuroreceptors, low potential for undesirable reactions, no significant off-target interactions, and no meaningful activity against hERG, 5-HT2B, or M1 muscarinic acetylcholine receptor.

When does Enveric Biosciences (ENVB) plan to file an IND application for EB-003?

Enveric Biosciences plans to file an Investigational New Drug (IND) application for EB-003 by the third quarter of 2025.

What is the timeline for Enveric Biosciences (ENVB) to begin clinical development of EB-003?

Enveric Biosciences expects to initiate clinical development of EB-003 by the end of 2025.

What potential advantages does EB-003 have over other antidepressants according to Enveric Biosciences' studies?

According to Enveric Biosciences' studies, EB-003 shows a favorable safety profile with low potential for cardiovascular and CNS adverse reactions, which are common issues with some approved antidepressants. It also demonstrates antidepressant, anxiolytic, and neuroplastogenic properties in animal models.