Enveric Tanks on Successful Tests
Enveric Biosciences, Inc. (NASDAQ: ENVB), a biotechnology company focused on developing novel neuroplastogenic small-molecule therapeutics for the treatment of depression, post-traumatic stress disorder (PTSD), and other neuropsychiatric disorders, today 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 results define the Maximum Tolerated Dose (MTD) and represent a key pipeline advancement landmark supporting the Company’s IND-enabling activities and preparation for First-in-Human clinical trials.
The DRF studies were designed to evaluate toxicity and toxicokinetics following daily oral dosing of EB-003, Enveric’s first-in-class neuroplastogen candidate that selectively engages serotonin 5-HT2A and 5-HT1B receptors.
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.
These results provide important safety and tolerability data to guide dosing strategies in future animal studies and First-in-Human studies.
Said CEO Joseph Tucker. “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 the IND submission to the FDA. This achievement moves us closer to clinical trial readiness for EB-003.”
ENVB shares dumped 24 cents, or 16.2%, to $1.22
