AB Science initiates recruitment in masitinib phase 3 study in severe persistent asthma

Jan 27 2011

AB Science SA (NYSE Euronext - FR0010557264 - AB), a pharmaceutical company specialising in the research, development and commercialisation of protein kinase inhibitors (PKIs), announced today the recruitment of the first patient in the phase 3 study evaluating masitinib in severe persistent asthma.

This is an international, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare the efficacy and the safety of masitinib at 6 mg/kg/day versus placebo in the treatment of patients with Severe Persistent Asthma treated with oral corticosteroids. The trial will enroll approximately 300 patients, across 60 centres around the world, randomised with a ratio 2 to 1 between the masitinib and placebo. The primary criterion will be the Asthma exacerbation rate (severe and moderate exacerbations) at 36 weeks adjusted on the available person-time (time to end of treatment).

Dr Leroyer (CHU Brest, France), principle investigator for this study declared: «There is a high unmet medical need in this disease where patients have a poor quality of life but can also have fatal exacerbations. In phase 2, masitinib generated promising efficacy results and was considered safe in this patient population. Over 16 weeks of treatment, the exacerbation rate was reduced by 40.5% in masitinib treated group. Focusing on patients requiring above 15mg equivalent prednisone per day, 31.6% of patients were weaned from oral corticosteroids in the masitinib treatment groups at week 16 versus none in the placebo arm. An improved asthma control (ACQ7) was observed in masitinib-treated patients (+42% versus +8% in placebo group). ITT (intention to treat) analysis showed patients treated with masitinib experienced a statistically significant change from baseline in ACQ7 total score (P < 0.001), while the placebo group showed no statistically significant change. It is the first time an oral treatment blocking mast cells is tested in this disease in a comparative pivotal phase 3 study, and we are eager to see the outcome ».

This phase 3 study is fully financed.