• Confirmation 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

CAMBRIDGE, Mass. / Jul 25, 2024 / Business Wire / Enveric 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.

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 (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.

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.

“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.”

“Burdensome drug delivery methods, like injections, may not be appealing to patients and can result in compliance challenges, often leading to the discontinuation of treatment altogether,” said Dr. Tucker. “Confirming that EB-003 can potentially be dosed orally is an important milestone, and we believe supports our overarching, patient-centered mindset, that non-hallucinogenic treatments must have favorable pharmacological properties that support patient adherence and reduce the treatment burden as they work to improve their mental health.”

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, EB-003, is a first-in-class approach to the treatment of difficult-to-address mental health disorders designed to promote neuroplasticity without inducing hallucinations in the patient. Enveric is also developing EB-002, formerly EB-373, a next generation synthetic prodrug of the active metabolite, psilocin, being studied as a treatment of psychiatric disorders. Enveric is headquartered in Naples, FL with offices in Cambridge, MA and Calgary, AB Canada. For more information, please visit www.enveric.com.

Forward-Looking Statements

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A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric’s filings with the Securities and Exchange Commission, including Enveric’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.