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ESTEVE Announces the Publication of Comprehensive Phase I Data for a Novel Oral, First-in-class New Chemical Entity (NCE),E-52862, a Sigma-1 Receptor Antagonist (S1RA) Being Developed for Pain
Date:9/4/2012

BARCELONA, Spain, September 4, 2012 /PRNewswire/ --

  • E-52862 is a potent, highly selective NCE with a novel mechanism of action (MOA; Sigma 1 Receptor (S1R) antagonism) currently being evaluated for the treatment of pain
  • Key data are outlined from three Phase I studies involving 175 male and female human subjects
  • These studies demonstrate a favourable safety, tolerability, pharmacokinetic and pharmacodynamic profile for E-52862
  • Phase II clinical trials evaluating E-52862 are ongoing

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[1].

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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
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