Enveric Biosciences 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. 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; 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, ABCanada.