ESTEVE announces the recent publication of data from the Phase I clinical trial programme of a novel, highly potent and selective, once-daily, S1RA E-52862, developed by the ESTEVE R&D team, in the British Journal of Clinical Pharmacology.
Mariano Sust, M.D., corresponding author, stated that "E-52862 represents a NCE with a novel, unprecedented mechanism of action for pain of different aetiologies. We are very encouraged by these results and look forward to future findings from the E-52862 clinical trial programme in due course."
To fully validate the safety and tolerability of E-52862, ESTEVE performed a rigorous phase I programme. This publication reports results from three, Phase I studies involving 175 human subjects. E-52862 demonstrated a favourable safety and tolerability profile across a robust panel of assessments including adverse event recording following questioning and spontaneous reporting; physical examinations; vital signs measurements; laboratory safety tests (haematology, blood coagulation, biochemistry, urinalysis); multiple psychometric tests; computerized cognitive evaluations (including assessment of executive function, working memory and learning, reaction time and psychomotor functions); and thorough cardiac monitoring (telemetry, triplicate 12-lead ECGs, 24-hour Holter ECGs). Pharmacokinetic assessments were performed in each study and results demonstrate a favourable pharmacokinetic and pharmacodynamic profile, supporting oral, once-daily administration of E-52862.
The E-52862 Phase I programme is now complete and included over 300 human subjects (more than 250 received E-52862). Results from the overall programme show favourable safety, tolerability, pharmacodynamic and pharmacokinetic profiles at all doses of E-52862 tested.