AB finds 350 patients for asthma study

AB Science has recruited 350 patients for the phase 3 study (AB07015) in severe persistent asthma uncontrolled by oral corticosteroids, for which the final results will be available at the end of 2017.

AB Science said it will take the study until completion, even if the interim analysis being successful, to prove efficacy with this large number of patients for registration. The company said that this decision has been noted to the Independent Data Monitoring Committee (IDMC) prior to the study`s interim analysis, which was planned with 50% of the patients.

Accoriding to the AB, IDMC has not reached AB Science with the interim analysis results but has indicated that the study can continue on the basis of the safety data and did not request implementation of the protocol resampling option – possibility of doubling the number of patients to be included.

Asthma uncontrolled by oral corticosteroid represents the most severe form of asthma and represents a high unmet medical need. The target population in adult patients is estimated at 70,000 in the USA and in the EU.

Also, in order to expand the asthma franchise, AB Science has started a new phase 3 study (AB14001) in asthma uncontrolled by high-dose inhaled corticosteroid plus long-acting beta-agonists (LABAs) and with elevated eosinophil level. This study has recruited its first patients.

Intellectual Property for masitinib is secured in asthma until 2032. The U.S. Patent and Trademark Office has granted a patent relating to methods of treating severe persistent asthma with masitinib. This patent, which expires in 2032, protects to the use of masitinib in the treatment of severe persistent corticosteroid-dependent asthma and severe persistent corticosteroid-resistant asthma, AB said.