AB Science receives FDA approval to commence asthma drug study

18 September 2011 (Last Updated September 18th, 2011 18:30)

AB Science has obtained investigational new drug status from the US Food and Drug Administration (FDA), allowing it to commence its Phase III study of masitinib in severe persistent asthma. Masitinib is an orally administered tyrosine kinase inhibitor that targets mast cells, which play

AB Science has obtained investigational new drug status from the US Food and Drug Administration (FDA), allowing it to commence its Phase III study of masitinib in severe persistent asthma.

Masitinib is an orally administered tyrosine kinase inhibitor that targets mast cells, which play a role in various cancers.

The double-blind, international, multicentre, randomised, placebo-controlled, two-parallel groups study will compare the efficacy and the safety of masitinib at 6mg/kg/day against placebo in the treatment of patients with severe persistent asthma uncontrolled with oral corticosteroids.

European authorisation to commence patient recruitment has already been granted.