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Enveric Biosciences Announces Preclinical Results Confirming Potential of EB-003 to be Dosed Orally
Confirmation of oral bioavailability and significant brain exposure in rodent models supports expedited development of EB-003, with Investigational New Drug
About this update from Enveric Biosciences, Inc.
[{"type":"text","content":"\nConfirmation of oral bioavailability and significant brain exposure in rodent models supports expedited development of EB-003, with Investigational New Drug (IND) filing and first patient dosed expected in 2025\n\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nEnveric Biosciences (NASDAQ: ENVB) (“Enveric”), a biotechnology company dedicated to the development of novel neuroplastogens for the treatment of neuropsychiatric disorders, today announced encouraging 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 (N,N-Dimethyltryptamine) and other psychedelic compounds.\n\n\nEB-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 (MAO-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.\n\n\nBased 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.\n\n\n“We continue to believe that EB-003 is substantially differentiated from the various psychedelic-inspired compounds in development. Not only does EB-003 offer the potential to significantly reduce or eliminate the hallucinogenic side-effect common to DMT and related analogs, but we now have confirmation that EB-003 can potentially be administered orally and penetrate the brain at levels expected to elicit the desired therapeutic effect,” said Joseph Tucker, Ph.D., CEO of Enveric. “We believe these results support our decision to advance EB-003 as our lead candidate and pursue a development timeline intended to enable the initiation of a clinical program and dosing of a first patient by end of 2025.”\n\n\n“Burdensome d...