Non-Hallucinogenic Psychedelic Treatment For Mental Health Disorders Shows Potential To Be Dosed Orally

Psychedelics biotech Enveric Biosciences ENVB announced positive preclinical results of its EB-003 drug candidate to be delivered via oral administration. EB-003 is a new, neuroplastogenic molecule designed to treat serious mental health disorders without the hallucinogenic effect typically associated with DMT (N,N-Dimethyltryptamine) and other psychedelic compounds. The results indicate that oral administration of EB-003 provides significant brain exposure in rodent models at potential therapeutic doses.

"We continue to believe that EB-003 is substantially differentiated from the various psychedelic-inspired compounds in development," stated Joseph Tucker, Ph.D., CEO of Enveric. "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. We believe these results support our decision to advance EB-003 as 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."

These positive results come on the heels of Enveric obtaining a US patent for its drug candidate EB-002. The license, issued by the US Patent and Trademark Office, includes broad claims for treating neurological disorders, including sleep disorders, depression, substance-related disorders and headaches. EB-002, a next-generation psilocin prodrug, is under development for neuropsychiatric disorders, initially focusing on anxiety.

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Clinical Development By The End Of 2025

EB-003 exhibited good oral bioavailability and brain penetration in a mouse pharmacokinetic study, 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 investigational new drug application for EB-003 by the third quarter of 2025 and initiate clinical development by the end of 2025.

"Burdensome drug delivery methods, like injections, may not be appealing to patients and can result in compliance challenges, often leading to 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 treatment burden as they work to improve their mental health."

Price Action

Enveric shares traded 4.28% higher at 50 cents per share after hours Wednesday.

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