Double-blind, placebo-controlled, multiple-ascending-dose study on the effects of ABIO-08/01, a novel anxiolytic drug, on perception and cognition, utilizing event-related potential mapping and low-resolution brain electromagnetic tomography


  • Conflict of interest: Alessandro Assandri is the CEO of the Contract Research Organisation Cross Research S.A., Fabrizio Nannipieri is the Director of Clinical Research of Abiogen Pharma S.p.A., and Sergio Rosini is Chief of Research and Development Division of Abiogen Pharma S.p.A. Peter Anderer, Bernd Saletu, Michael Wolzt, Svetlana Culic, and Gerda M. Saletu-Zyhlarz have no financial affiliation or other relationship relevant to the subject matter of this article.


Early pharmacological studies in animals demonstrated that ABIO-08/01, a new isoxazoline, exerted anxiolytic and anticonvulsant, but also cognition-enhancing properties. Thus, the aim of the present double-blind, placebo-controlled multiple-ascending-dose study was to investigate the effect of the new compound on event-related potentials (ERPs). In a randomized ascending-dose design for phase-1 studies, 16 young healthy male subjects aged 30.2 ± 5.7 years received three ascending drug doses (10, 20, and 40 mg) and placebo for 7 days, with a washout period of 8 days in between. Auditory ERPs were recorded pre-dose and 2 h post-dose on days 1 (acute effect) and 5 (subacute and absolute superimposed effect). Descriptive statistics with one confirmatory statement on P300 latency demonstrated a significant shortening after acute, subacute, and superimposed administration of 40 mg ABIO-08/01. While ERP amplitudes showed only minor effects, low-resolution brain electromagnetic tomography (LORETA) demonstrated that ABIO-08/01 promotes more efficient information processing by reallocating perceptual and cognitive ERP resources. Thus, our ERP studies confirm early pharmacological findings in animals of a cognition-enhancing effect of ABIO-08/01, which is interesting in the context of the anxiolytic mode of action of the compound as its CNS effects are quite different from those of anxiolytic sedatives, such as benzodiazepines. Copyright © 2008 John Wiley & Sons, Ltd.