CAMBRIDGE, Mass.– Enveric Biosciences, Inc. (NASDAQ: ENVB), a biotechnology company developing novel neuroplastogenic small-molecule therapeutics for neuropsychiatric disorders, today announced it has successfully completed 7-day Dose Range Finding (DRF) toxicology studies in two preclinical species for its lead candidate, EB-003. The results established the Maximum Tolerated Dose (MTD) and represent a major advancement as the company moves toward IND-enabling studies and First-in-Human clinical trials.
The DRF studies assessed toxicity and toxicokinetics following daily oral dosing of EB-003, Enveric’s first-in-class neuroplastogen designed to selectively engage serotonin 5-HT2A and 5-HT1B receptors. Results confirmed oral bioavailability in both species, with dose-dependent increases in plasma EB-003 concentrations. At higher doses, central nervous system (CNS)-related effects were observed, indicating brain penetration and on-target activity.
“Completion of the DRF toxicology studies and establishment of the MTD in two preclinical species is a significant and necessary milestone in the development of EB-003,” said Dr. Joseph Tucker, Chief Executive Officer of Enveric. “These findings provide a well-defined reference point for planning human dosing and position us to advance EB-003 into definitive toxicology, safety pharmacology, and genotoxicity studies required for IND submission to the FDA. This achievement moves us closer to clinical trial readiness for EB-003.”
The determination of the MTD provides critical insight into the therapeutic dose range versus toxic limits, informing the design of both future animal studies and human trials. The confirmation of brain penetration and CNS-related activity, combined with oral bioavailability, reinforces the compound’s intended use in treating chronic neuropsychiatric conditions.
EB-003 is a first-in-class neuroplastogen designed to promote adaptive neural circuit remodeling by selectively targeting serotonin receptors associated with neuroplasticity and mood regulation. Preclinical data suggest that EB-003 can achieve these effects without triggering hallucinogenic responses, potentially enabling safe outpatient administration. The candidate is advancing through preclinical development with the goal of entering human clinical testing.
