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Enveric Biosciences Preclinical Pharmacokinetic Studies of EB-003 Support Oral Bioavailability, Demonstrate Brain Penetration, and Show No Evidence of Hallucination-like Behavior
Dose-proportional oral bioavailability without clinical signs, including those associated with hallucinogenic compounds, was demonstrated in rat and dog
About this update from Enveric Biosciences, Inc.
[{"type":"text","content":"\nDose-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\n\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nEnveric 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.\n\n\nThe 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.\n\n\nAdditionally, 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.\n\n\n“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.”\n\n\n“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 ...