AB Science SA announced the launch of a phase 3 clinical trial in the treatment of Alzheimer's disease with masitinib, as well as the recruitment of the first patients in this study in several countries.  This is an international, multicenter, randomized (1:1:1 ratio), double-blind, placebo controlled, three parallel group phase 3 study to compare the efficacy and safety of masitinib at two different doses in the treatment of patients with mild to moderate Alzheimer's disease. Study treatment will be given as add-on therapy to patients who have been treated for a minimum of 6 months with a stable dose of cholinesterase inhibitors (rivastigmine) and/or memantine, with no changes foreseen in therapy throughout the study. The study aims at evaluating the effect of masitinib after 24 weeks of treatment on cognition and memory assessed by Alzheimer's Disease Assessment Scale (ADAS-Cog) and on self-care and activities of daily living assessed by Alzheimer's Disease Assessment Cooperative Study Activities on Daily Living (ADCS-ADL) at week-24. This study, for which recruitment has started in Europe and other countries, will enroll approximately 400 patients. As a reminder, masitinib is one of the few drugs that have generated significant efficacy results in phase 2 studies. In fact, the phase 3 study follows a phase 2 study, in which masitinib administered as an add-on therapy to standard care during 24 weeks showed promising signs of retarding the rate of cognitive decline of Alzheimer's disease as compared against placebo, with an acceptable tolerance profile. Improvement in cognitive function and functional capacity was seen in the masitinib treatment group, as evident through the sustained and statistically significant response in ADAS-Cog, as well as the mean change in ADAS-Cog and ADCS-ADL values relative to baseline. The phase 2 results have been published: Alzheimers Res Ther. 2011 Apr. 19;3(2):16. doi: 10.1186/alzrt75. The objective of the double-blinded, randomized in parallel groups and placebo-controlled study was to evaluate masitinib, administered orally over 24 weeks, in patients suffering from mild-to-moderate Alzheimer's disease. Response was measured by change in ADAS-Cog, ADAS-ADL and MMSE scores after 24 weeks of treatment. A total of 35 patients were included in this study. The rate of clinically relevant cognitive decline according to the primary endpoint, ADAS-Cog response (increase > 4 points), was significantly lower with masitinib treatment compared to placebo after 12 and 24 weeks (6% versus 50% for both; p=0.040 and p=0.046, respectively). Moreover, whilst the placebo treatment-arm showed worsening mean ADAS-Cog, ADCS-ADL, and MMSE scores, the masitinib treatment-arm reported improvements, with statistical significance between treatment-arms at weeks 12 and/or 24 (respectively, p=0.016 and 0.030; p=0.035 and 0.128; and p=0.047 and 0.031). Adverse events occurred more frequently with masitinib treatment (65% versus 38% of patients); however, the majority of events were mild or moderate and transient.

AB Science S.A. announced consolidated earnings results for the year ended Dec. 31, 2012 and consolidated revenue results for the first quarter of 2013. Total revenues for the year 2012 amounted to EUR 1,304,000 compared with EUR 1,104,000 in the previous year. Operating loss amounted to EUR 10,613,000 compared with EUR 9,716,000 reported in 2011. Net loss attributable to equity holders of the parent company was EUR 10,985,000 or EUR 0.34 per diluted share against EUR 9,651,000 or EUR 0.31 per diluted share reported last year. Net cash used in operating activities was EUR 324,000 against EUR 433,000 and acquisitions of financial assets was EUR 8,500,000 against EUR 17,000,000 reported last year. AB Science revenues in the first quarter of 2013 amounted to EUR 571,000 versus EUR 321,000 in the first quarter of 2012, up 78%. These revenues derive from the commercial exploitation of masitinib in veterinary medicine in Europe and in the United States.

AB Science S.A. will be added to SBF 120 Index