• Key preclinical milestone designed to establish safety profile and maximum tolerated dose for anticipated clinical trial of EB-373

CAMBRIDGE, Mass. / Oct 18, 2023 / 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 initiation of Good Laboratory Practice (GLP)-toxicology and safety pharmacology studies for lead prodrug candidate EB-373, the company’s next generation psilocin prodrug being developed for the treatment of psychiatric disorders.

Enveric has commenced preclinical studies to evaluate repeat-dose toxicity in animals, which are designed to strengthen the broad safety margin established in previous non-GLP studies and are intended to generate regulatory-compliant data that will help advance EB-373 to first-in-human clinical studies. Assessing the safety and tolerability of repeated-dosing in preclinical studies provides critical data to support repeat-dosing in future human clinical trials, which may broaden the potential therapeutic application of EB-373.

The GLP toxicology and safety studies are a final step as Enveric prepares to enter clinical-stage trials with its novel, next generation synthetic psilocin prodrug. Enveric previously reported the results of non-GLP preclinical studies that showed a favorable safety and tolerability profile of EB-373 and demonstrated rapid conversion from prodrug to active metabolite psilocin, with EB-373 blood concentrations approximately 100-fold lower than psilocin, reducing to undetectable levels after two hours. Notably, psilocin blood concentration peaked at one hour after administration of EB-373 indicating a quicker onset of effect.

“The GLP toxicology and pharmacology studies represent a significant development milestone for our EB-373 program as we seek to establish the safety profile and maximum tolerated doses, key requirements for clinical trial application,” said Joseph Tucker, Ph.D., Director and CEO of Enveric. “Based on prior preclinical research, we expect the final safety profile of EB-373 to confirm the compound’s ability to allow for repeat dosing, which would support greater therapeutic applicability and presents an important differentiator from other psilocin based therapeutics.”

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, the EVM201 Series, comprises next generation synthetic prodrugs of the active metabolite, psilocin. Enveric is developing the first product from the EVM201 Series – EB-373 – for the treatment of psychiatric disorders. Enveric is also advancing its second program, the EVM301 Series, expected to offer a first-in-class, new approach to the treatment of difficult-to-address mental health disorders, mediated by the promotion of neuroplasticity without also inducing hallucinations in the patient. 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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