Enveric Biosciences announced EB-003 preclinical results indicating the potential for the drug candidate to be delivered via oral administration with significant brain exposure in rodent models at potential therapeutic doses. EB-003 is a novel, neuroplastogenic molecule designed to treat severe mental health disorders without the hallucinogenic effect typically associated with DMT and other psychedelic compounds. EB-003 exhibited good oral bioavailability and brain penetration in a mouse pharmacokinetic study, with a brain:plasma exposure ratio of 1.5. Furthermore EB-003 demonstrated significant in vitro stability against human monoamine oxidase-A as well as in mouse, rat, dog, and human liver microsomes. By contrast, DMT and similar analogs are not orally available due to rapid metabolism by MAO-A. Based on these results, Enveric is accelerating its evaluation of EB-003 in several in vivo animal efficacy models to determine the optimal therapeutic indication for clinical development and expected dose range. Enveric now expects to file an IND application for EB-003 by the third quarter of 2025 and initiate clinical development by the end of 2025.
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