August 28, 2025 — Leads & Copy — Enveric Biosciences, Inc. (NASDAQ: ENVB) has announced the successful completion of 7-day Dose Range Finding (DRF) toxicology studies in two preclinical species for its lead drug candidate, EB-003.
The studies defined the Maximum Tolerated Dose (MTD) and represent a key pipeline advancement supporting IND-enabling activities and preparation for First-in-Human clinical trials. The DRF studies evaluated toxicity and toxicokinetics following daily oral dosing of EB-003. The findings confirmed oral bioavailability in both species, with dose-dependent increases in plasma EB-003 concentrations observed across the tested range. At higher dose levels, central nervous system (CNS)-related effects were noted in both species, indicative of brain penetration and potential on-target activity.
According to Dr. Joseph Tucker, Chief Executive Officer of Enveric, 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, providing a reference point for planning human dosing and positioning the company to advance EB-003 into definitive toxicology, safety pharmacology, and genotoxicity studies required for the IND submission to the FDA.
EB-003 is a neuroplastogen designed to selectively engage serotonin 5-HT2A and 5-HT1B receptors, targets implicated in neuroplasticity and mood regulation, without inducing hallucinations. Preclinical findings to date support the potential of EB-003 to promote adaptive neural circuit remodeling in animals without inducing motor responses predictive of hallucinogenic effects in humans.
For more information, please visit www.enveric.com.
Source: Enveric Biosciences
