AB Science SA, a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors, has started phase III clinical study of masitinib in the treatment of Alzheimer's disease and also announced the recruitment of the first patients in this study in several countries. The study is a global, phase III, multicentre, randomized in a ratio 1: 1: 1, double blind, placebo-controlled study with three parallel groups to assess the efficacy and safety of masitinib at two different doses in patients with mild to moderate disease Alzheimer.

The study treatment is given in adjunctive therapy for patients treated for at least six months in a cholinesterase inhibitor (rivastigmine) and / or memantine without change provided for the duration of the study.

The study aims to evaluate the effect of masitinib after 24 weeks of treatment on cognition and memory assessed by the Alzheimer's Disease Assessment Scale (ADAS-Cog) and self and activities of daily life, the Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCSADL) at week 24. This study, which began recruitment in Europe and other countries, needs to recruit about 400 patients.

As a reminder, masitinib is one of the few drugs have generated significant efficacy results in phase II. Indeed, this phase III study follows a phase II study in which masitinib administered as adjunctive therapy to standard treatments for 24 weeks showed promising signs in retarding the rate of cognitive decline compared to placebo, with a profile acceptable tolerance. Compared with placebo, a significant improvement in cognitive function and functional capacity was observed in the group treated with masitinib, as was made evident by the sustained and statistically significant in the ADAS-Cog response, as well as the change in the median values of ADAS-Cog and ADCS-ADL compared to baseline. These results phase II has been published (Alzheimers Res Ther 2011 Apr 19, 3 (2):.. 16 doi: 10.1186/alzrt75).

The study double-blind, randomized, parallel group, placebo-controlled, had the objective of evaluating the activity of masitinib administered orally for 24 weeks to patients suffering from mild to moderate Alzheimer disease. The activity was found on markers ADAS-Cog, ADCS-ADL, MMSE and after 24 weeks of treatment. In total 35 patients were included in this study. The rate of cognitive decline, as measured by the first variable (increase = 4 points the ADAS-Cog) was statistically lower in patients receiving masitinib in patients receiving placebo after 12 and 24 weeks (6% against 50% in the two periods, p = 0.040 and p = 0.046, respectively). Moreover, while patients receiving placebo recorded a deterioration ADAS-Cog, ADCS-ADL, and MMSE, patients receiving masitinib recorded an improvement, with a statistically significant difference compared to placebo after 12 and 24 weeks (Respectively, p = 0.016 and 0.030, p = 0.035 and 0.128, and p = 0.047 and 0.031). Adverse events were more frequent in patients receiving masitinib (65% against 38%) but were mostly mild to moderate and transient.

Alzheimer's disease is the most common worldwide neurodegenerative disease. In fact, Alzheimer's disease is associated with a high risk of death. In the United States, it is cause of death of the population. Moreover, regardless of the cause of death, 61% of patients Alzheimer's disease at the age of 70 years may die before the age of 80, while only 30% of healthy people have this risk. In particular, the inability to move that develops advanced stage Alzheimer's disease makes the patient more susceptible to infections, particularly pneumonia, which can be fatal. Alzheimer's disease is characterized by the appearance of lesions that invade progressively and destroy brain neurons, resulting in progressive cognitive decline and memory. Both types of lesions are the amyloid deposits in the brain parenchyma (amyloid plaques) or blood vessels blood (amyloid angiopathy), and neurofibrillary tangles. In these lesions adds inflammation contributes to alter neurons. There is still no treatment that can stop or reverse these pathological processes.

Masitinib is a new tyrosine kinase inhibitor, administered orally, blocking a cellular target, the mast cells, key immune cell, and a limited number of kinases that play a key role in some cancers. Because its novel mechanism of action, masitinib can be developed in a large number of conditions in oncology, in inflammatory diseases, and diseases of the central nervous system. By its inhibitory activity certain essential in some oncogenic processes kinases, masitinib may have an effect on the regression tumour, alone or in combination with chemotherapy. Through its activity on the mast cell and certain kinases essential for the activation of inflammatory cells and fibrosing tissue remodeling, masitinib may have a effect on the symptoms associated with certain inflammatory diseases and central nervous system.