Enveric: PK animal studies demonstrate ‘more favorable’ side effect profile

Enveric Biosciences announced positive results from PK animal studies demonstrating oral bioavailability, rapid onset of action and systemic clearance, and a more favorable side effect profile for the company’s lead product candidate, EB-373. Pharmacokinetic PK measurements that were consistent in both dogs and rats confirmed that oral administration of EB-373, a psilocin-prodrug targeting anxiety disorders, resulted in dose-dependent increase in psilocin blood concentration, correlating to levels expected to be effective in humans. EB-373 demonstrated a very rapid conversion from prodrug to active metabolite psilocin, with concentrations of EB-373 that were approximately 100-fold lower in blood than psilocin and reached undetectable level after two hours. Additionally, psilocin blood concentration peaked at one hour after administration of EB-373 consistent with quicker onset of clinical effect. The side effect profile was well tolerated overall, with notably no vomiting and no serious adverse events observed at any dose level. ..Dr. Tucker added, “EB-373 treated animals exhibited reduced overall side effects, including GI upset and vomiting, compared to data from psilocybin reported in the literature. GI upset, vomiting, and the timing of both onset and resolution of effect are key target effects that EB-373 was designed to address leveraging our leading PsyAI machine-learning technology.” Enveric intends to present thorough analyses of the PK animal studies for EB-373 at a future scientific conference.