• EB-003 is a novel, neuroplastogenic molecule designed to treat severe mental health disorders without the hallucinogenic effect typically associated with psychedelic-based compounds
• Enveric is advancing pre-clinical development of EB-003 with a pre-IND meeting targeted for early 2025

CAMBRIDGE, Mass. / Jun 25, 2024 / Business Wire / Enveric 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 Company is prioritizing the development of EB-003, its first-in-class approach to address difficult-to-treat mental health disorders. EB-003 and other neuroplastogens developed by Enveric are designed to promote neuroplasticity without inducing hallucinations, a hallmark side effect of many psychedelic and psychedelic-inspired compounds. Enveric is currently advancing pre-clinical development activities for EB-003 and targeting a Pre-IND meeting with the U.S. Food and Drug Administration (FDA) for early 2025.

“EB-003 has the potential to be a breakthrough neuroplastogen drug candidate that offers the ability to treat resistant mental health disorders without the hallucinogenic effect typically associated with psychedelic-based molecules,” said Joseph Tucker, Ph.D., Director and CEO of Enveric. “Minimizing the hallucinatory effect is vital for the clinical development of EB-003 since it will allow for truly blinded placebo-controlled clinical trials and eliminate the need for co-administration of psychotherapy. In addition, minimizing the hallucinatory effect will enable the administration of such therapies in an outpatient setting, and support a more widespread acceptance for psychedelic-inspired drugs.”

Dr. Tucker continued, “The potential advantages of EB-003 were underscored during the recent U.S. FDA Psychopharmacologic Drugs Advisory Committee for Lykos Therapeutics’ MDMA-assisted therapy (Lykos Adcom). During the Lykos Adcom meeting, the advisory committee raised several issues that likely will need to be overcome by hallucination-inducing psychedelics currently in development. Notably, ‘expectation bias’ and the inability to adequately blind both patients and study monitors due to the psychedelic properties of the Lykos candidate decreased reviewer confidence in the efficacy data reported from the studies. Reviewers also questioned the relative contributions of the pharmacological treatment versus the supportive psychotherapy to the reported outcomes and expressed concerns regarding the lack of standardization of the psychotherapy. Enveric believes EB-003 is uniquely designed to address these valid concerns of the Advisory Committee and accordingly have determined to elevate EB-003 to be our lead development candidate to accelerate our plans to advance it to human clinical studies.”

Dr. Tucker concluded, “Data produced thus far has demonstrated EB-003’s ability to bind to the 5-HT2A receptor and induce neuroplasticity while eliciting no significant head twitch response in mice, a behavioral model used to predict the likelihood of a molecule to produce hallucinogenic effects in humans. Confirming this observation in humans will be a top priority in designing the EB-003 clinical program."

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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