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Enveric Biosciences Reports Year End Progress for Preclinical Development of Lead Prodrug Candidate EB-373
The ongoing GLP Safety and Toxicology Program of EB-373 is thus far proceeding on time with favorable results CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Enveric
About this update from Enveric Biosciences, Inc.
[{"type":"text","content":"\nThe ongoing GLP Safety and Toxicology Program of EB-373 is thus far proceeding on time with favorable results\n\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nEnveric 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 GLP Safety and Toxicology Program of EB-373 is proceeding as planned thus far with favorable results.\n\n\nIn-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.\n\n\n“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.”\n\n\nA summary of the EB-373 preclinical program is as follows:\n\n\n\nGLP 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.\n\n\n\nEB-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 acce...