Enveric Biosciences Selects EB-003 as Lead Drug Candidate from EVM301 Series
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Insights
The selection of EB-003 as a lead drug candidate by Enveric Biosciences represents a significant stride in the field of neuropsychiatric drug development. The compound's ability to promote neuroplasticity—an essential process for learning and memory that is often impaired in mental health disorders—without inducing hallucinations is a noteworthy innovation. This characteristic could potentially make EB-003 a groundbreaking treatment option for depression, anxiety and addiction.
Neuroplasticity enhancers that avoid hallucinogenic effects may offer a therapeutic advantage by minimizing side effects and regulatory hurdles associated with psychedelic compounds. EB-003's partial agonism at the 5-HT2A receptor, a target implicated in many neuropsychiatric disorders, suggests a mechanism of action that could offer benefits similar to psychedelics but with a more favorable safety profile. This is further supported by the lack of 5-HT2B receptor agonism, which is associated with cardiac valvulopathy risks.
Moreover, the evidence of EB-003's ability to return mice to pre-stressed behavior in anxiety and depression models, along with its high membrane permeability, indicates that the drug could effectively reach its central nervous system targets. The compound's pharmacokinetic profile, including a moderate half-life, suggests that it could be administered with flexible dosing regimens, which is critical in tailoring treatments to individual patient needs.
The announcement of Enveric Biosciences' transition from a discovery phase company to a drug development company with EB-003 is a pivotal event that could influence the company's market valuation and investor interest. The move from preclinical research to IND-enabling activities is a high-stakes phase in biotech development, often serving as a litmus test for a company's scientific and operational capabilities.
Investors typically scrutinize such developments closely, as the outcomes of IND-enabling studies and subsequent clinical trials can significantly impact the potential revenue and growth trajectory of the company. Given the high unmet need in treating mental health disorders with new pharmacological approaches, a successful advancement of EB-003 could position Enveric as a strong player in the neuropsychiatric treatment market.
However, it is crucial to note the inherent risks involved in drug development. The transition to clinical trials does not guarantee success and the path to FDA approval is fraught with potential challenges, including demonstrating safety and efficacy in human subjects. The market will be watching closely for further data releases and regulatory milestones that could affect Enveric's stock performance.
The preclinical data for EB-003 suggests a promising profile for addressing mental health disorders, which is a critical area of medicine with considerable demand for new treatment options. The utilization of proprietary computational chemistry and artificial intelligence platforms like PsyAI™ underscores the innovative approach Enveric is taking in drug discovery, potentially reducing the time and cost associated with traditional drug development.
From a clinical research perspective, the selection of EB-003 based on its low head-twitch response in mice is significant, as it suggests a lower risk of hallucinogenic side effects, which are a common concern with psychedelic-based therapies. This could lead to a broader acceptance and usage of EB-003, should it prove effective in humans.
Furthermore, the specificity of EB-003 in binding to the 5-HT2A and 5-HT1A receptors, while avoiding the 5-HT2B receptor, is indicative of a targeted approach that could mitigate safety concerns and improve the drug's therapeutic index. The next steps for Enveric will be critical, as IND-enabling studies will need to confirm these findings and establish a solid foundation for the safety profile before entering clinical trials.
Enveric to initiate preclinical development of EB-003 in 2024 in preparation for IND submission
EB-003 was identified following a rigorous selection process during which Enveric utilized its proprietary computational chemistry and artificial intelligence (AI) drug-discovery platform, PsyAI™, to simulate interactions between indolethylamine derivatives and the 5-HT2A receptor to design novel molecules with reduced head-twitch response (HTR) in mice. HTR is a rodent behavioral model used to predict whether a molecule is likely to produce hallucinogenic effects in humans. In total, 51 proprietary indolethylamine analogs were screened, from which three candidates were selected based on the molecules’ ability to bind to the 5-HT2A receptor and induce neuroplasticity while eliciting no significant HTR across a wide dose range.
From the top three candidates, EB-003 was chosen as lead based on its superiority in numerous relevant measures.
EB-003:
- Demonstrated a low HTR profile in mice at all doses tested (up to 10 mg/kg).
- Promoted neuroplasticity at a level similar to that induced by the hallucinogenic positive control N,N-dimethyltryptamine (DMT).
- Exhibited partial agonism of the 5-HT2A receptor, binding with a Ki of 0.2 mM, which is within the range of binding affinity of the known 5-HT2A agonists DMT and psilocin.
- Resulted in a return to pre-stressed behavior in both the marble-burying (MB) and sucrose preference (SP) tests, which are models for anxiety and depression, respectively, when administered to mice at a dose of 10 mg/kg by intraperitoneal injection.
- Bound the 5-HT1A receptor with a Ki of 3.3 mM. 5-HT1A receptor agonists and partial agonists have demonstrated clinical efficacy at relieving anxiety and depression.
- Was not an agonist of the 5-HT2B receptor. 5-HT2B receptor agonism can lead to cardiac valvulopathy and is therefore considered a toxicity signal sufficient to preclude clinical development.
- Showed moderate exposure in pharmacokinetic analysis with a half-life of approximately 30 minutes, which is anticipated to enhance optionality in the future determination of dosing regimens.
- Revealed high membrane permeability in assays, indicating the potential for excellent blood brain barrier permeability, an important consideration for drugs that target receptors in the brain.
- Overall toxicity parameters were similar to or below those for DMT and psilocin.
“Selection of EB-003 as the lead development candidate from our EVM301 Series is an important inflection point for Enveric and our mission to develop groundbreaking, psychedelic-inspired drug technologies that offer the potential to treat severe mental health disorders without the hallucinogenic effect typically associated with psychedelic-based molecules,” said Joseph Tucker, Ph.D., Director and CEO of Enveric. “Importantly, moving EB-003 into our development pipeline marks a transformative step for Enveric as we complete our period as a discovery phase company and fully transition to the next phase as a drug development company. With EB-003, we have identified a novel, neuroplastogenic molecule that exhibits several key properties that align with favorable tolerability and efficacy in relevant animal models. We now look forward to initiating IND enabling activities in early 2024 that will enable us to file an IND and start clinical trials of EB-003 as we seek to introduce a new treatment paradigm for depression and anxiety disorders.”
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, the EVM201 Series, comprises next generation synthetic prodrugs of the active metabolite, psilocin. Enveric is developing the first product from the EVM201 Series – EB-373 – for the treatment of psychiatric disorders. Enveric is also advancing its second product, EB-003, as a first-in-class approach to the treatment of difficult-to-address mental health disorders by promoting neuroplasticity without inducing hallucinations in the patient. Enveric is headquartered in
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Source: Enveric Biosciences
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