Enveric Biosciences Reports Year End Progress for Preclinical Development of Lead Prodrug Candidate EB-373
- The GLP Safety and Toxicology Program of EB-373 is proceeding on time with favorable results
- In-life portion of the repeat dose toxicology studies have been completed
- Cardiac, respiratory, CNS safety pharmacology studies, an in vitro hERG current study, and genotoxicity studies have been completed
- Enveric expects to finalize all preclinical activities involving EB-373 in the first quarter of 2024 in preparation for a first-in-human clinical trial
- The preclinical program for EB-373 has consistently confirmed the safety and oral bioavailability of the drug
- The drug's pharmacological properties observed in preclinical animal models have validated the company's AI-backed molecular design aimed at optimal control over the timing and length of the hallucinatory experience in humans
- None.
Insights
From a pharmacological perspective, the progression of Enveric Biosciences' GLP Safety and Toxicology Program for EB-373 is a significant milestone in drug development. The completion of the in-life portion of repeat dose toxicology studies and the preliminary findings indicating a broad margin of safety and tolerability are crucial. These results suggest that EB-373 could be a viable candidate for further clinical development. The drug's oral bioavailability and its rapid conversion to the active metabolite psilocin are particularly promising, as these characteristics could lead to improved patient compliance and a better therapeutic profile compared to existing treatments. The potential reduction in gastrointestinal side effects and the rapid onset of action enhance the drug's profile, which is vital for patient-centric care in mental health treatments.
Moreover, the in vitro cardiotoxicity assays, particularly the hERG current study, are essential for predicting the risk of QT interval prolongation—a known risk factor for cardiac events. The acceptable cardiovascular safety range observed is reassuring for the drug's future in clinical trials. It is important to note that the hERG channel is critical in cardiac repolarization and drugs that inhibit this channel can lead to serious cardiac adverse events. The absence of toxic metabolites and significant drug-drug interactions further supports the drug's safety profile. These findings will be integral in the design of first-in-human clinical trials and in discussions with regulatory agencies.
From an investment and market perspective, the positive progression of EB-373 through its preclinical stages could have notable implications for Enveric Biosciences' market valuation and investor sentiment. The company's focus on developing treatments for mental health conditions, such as depression, anxiety and addiction, taps into a growing market demand for novel and effective therapeutics. The successful completion of preclinical studies and movement towards human trials is often a catalyst for biotech stocks, as it de-risks the asset to some extent and can attract partnership or licensing deals.
Furthermore, the mention of AI-backed molecular design in the drug's development process may pique investor interest in Enveric's innovative approach. The ability to control the hallucinatory experience while achieving therapeutic effects could position EB-373 as a potential leader in the psychedelic-based treatment space, which is currently gaining traction. However, investors should remain cautious, as the biotech sector is highly volatile and the success of clinical trials is uncertain. It is also worth noting that the market for psychedelic-based therapies is still emerging and regulatory hurdles could impact the speed of market entry and adoption.
The announcement of EB-373's favorable preclinical results is a critical step towards entering first-in-human trials. The design and outcomes of these preclinical studies are foundational for establishing the initial safety profile required by regulatory bodies such as the FDA before advancing to human testing. The comprehensive safety pharmacology studies, including CNS, respiratory and cardiovascular assessments, provide a robust dataset to predict human responses. The detailed toxicology and ADME-tox studies are fundamental to understanding the drug's behavior in the body and potential risks, which is paramount for ensuring patient safety during clinical trials.
As EB-373 approaches clinical development, the data collected thus far will be instrumental in determining appropriate dosing regimens and monitoring parameters. The pharmacokinetic characteristics, such as the rapid systemic clearance, may offer advantages in managing and mitigating adverse effects during clinical trials. Additionally, the ability to predict and control the duration of the hallucinatory experience could be a significant differentiator in the therapeutic landscape, potentially improving the acceptability and feasibility of EB-373 as a treatment option in a clinical setting.
The ongoing GLP Safety and Toxicology Program of EB-373 is thus far proceeding on time with favorable results
In-life portion of the repeat dose toxicology studies have been completed, and the results are being analyzed. In addition, cardiac, respiratory, CNS safety pharmacology studies, an in vitro hERG current study, and genotoxicity studies have been completed and are undergoing analyses. Enveric expects to finalize all preclinical activities involving EB-373 in the first quarter of 2024 in preparation for a first-in-human clinical trial.
“Our research team has continued to diligently advance the preclinical program for our lead novel psilocin prodrug, EB-373, as we anticipate initiating first in human trials in 2024,” said Joseph Tucker, Ph.D., Director and CEO of Enveric. “Analyses of data collected to date have consistently confirmed the safety and oral bioavailability of EB-373, with a dose-dependent increase in EB-373 blood concentration detected followed by its rapid conversion to the active metabolite psilocin. Further, pharmacological properties observed in preclinical animal models have validated our AI-backed molecular design aimed at optimal control over the timing and length of the hallucinatory experience in humans, while also achieving the desired therapeutic effect for difficult-to-treat mental health indications.”
A summary of the EB-373 preclinical program is as follows:
- GLP toxicology studies of EB-373 in orally dosed rats and dogs are currently in advanced stages, with all in-life activities completed. Preliminary indications suggest a broad margin of safety and tolerability is maintained with repeat dose testing. Complete analysis and final reporting are expected by the end of Q1 2024.
- EB-373 safety pharmacology studies in rats and dogs, employing the core battery of respiratory, CNS and cardiovascular (CV) assessments, are completed. Preliminary results have demonstrated an acceptable range of safety for each of these vital organ systems in orally dosed animals. Complete analysis and final reporting are expected by the end of December 2023.
- In vitro assessment of cardiotoxicity potential, involving assays targeting key CV targets including hERG, Cav 1.2 and Nav 1.5 have been completed. Results suggest an acceptable range of cardiovascular safety well above the proposed clinical dose range.
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Non-GLP in vivo dose range finding (DRF) studies conducted in rats and dogs, completed in August 2023, demonstrated effective oral bioavailability of EB-373, with dose-dependent increase in psilocin blood concentration detected in both species.
- Key outcomes from these PK assessments strongly suggest a broad range of tolerance, with a potential for reduced gastrointestinal (GI) upset and vomiting, as well as a rapid onset of action and systemic clearance, improving on PK characteristics of psilocybin.
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In vitro absorption, distribution, metabolism and excretion toxicology (ADME-tox) studies and a metabolic identification evaluation have been completed and confirmed minimal potential for adverse drug reactions (ADR), with no toxic metabolites identified, and no indication of any significant drug-drug interactions.
- Results from this study also demonstrated rapid conversion of EB-373 to the active metabolite psilocin, consistent with previously reported pharmacokinetic (PK) studies.
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 program, the EVM301 Series, expected to offer a first-in-class, new approach to the treatment of difficult-to-address mental health disorders, mediated by the promotion of neuroplasticity without also inducing hallucinations in the patient. Enveric is headquartered in
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Source: Enveric Biosciences
FAQ
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