Enveric announces positive pharmacology/safety data for Lead Product, EB-003

Enveric Biosciences announced positive results for preclinical safety and pharmacology studies, which evaluated off-target interactions of its lead drug candidate, EB-003, and confirmed selective activity with desired serotonergic neuroreceptors. ..Results of this large in vitro screen suggest a favorable safety profile for EB-003 with no significant off-target interactions detected. Notably, EB-003 showed no meaningful activity against hERG or 5-HT2B, targets related to cardiovascular adverse drug reactions ADRs . Drug interaction with hERG can elicit fatal cardiac arrhythmias, while off-target activation of the serotonin receptor 5-HT2B located in cardiac tissues is known to induce pulmonary hypertension and serious valvular heart disease. Several approved antidepressants and neuroactive drugs have seen reduced use and/or have been removed from the market based on interactions with these receptors, and the harmful downstream impacts on patient safety. ..Joseph Tucker, Ph.D., Director and CEO of Enveric, commented, “From our perspective, positive results from this key in vitro safety screen further derisk EB-003. These results, along with previously reported antidepressant, anxiolytic, and neuroplastogenic properties in animal models, enhance our confidence in this lead compound. We are excited to progress EB-003 through the final steps of the Company’s Investigational New Drug IND application, including in vivo toxicology and safety pharmacology activities, all scheduled to begin in Q4 of 2024.” Enveric recently announced preclinical data confirming the oral bioavailability of EB-003 and its ability to produce brain exposure at therapeutically relevant levels. Enveric expects to file an IND application for EB-003 by the third quarter of 2025 and initiate clinical development by the end of 2025.