Insmed says that it is pleased with results from its ongoing CLEAR-110 extension study of Arikace inhaled liposomal amikacin for the treatment of P. aeruginosa infections in cystic fibrosis patients. Data from 98 patients who completed the first year of the two-year study showed that Arikace was well tolerated, the company said, and patients experienced continued reduction in bacterial density in the sputum and continued improvement in FEV1 from baseline.
The company said that adverse events during the study were “consistent with those expected in a population of CF patients receiving inhaled medicines.”
Insmed Executive VP Development and Chief Medical Officer Renu Gupta commented, “As we announced on July 1, 2013, the Phase 3 study of Arikace achieved its primary endpoint and demonstrated that Arikace administered once a day is non-inferior to the standard of care which is administered twice a day. This longer-term study demonstrates our continued commitment to the CF patients and to gathering longer term data to clarify the safety and efficacy profile of our drug candidate. The data we are reporting today are consistent with the findings from our earlier longer term study of Arikace and we believe further strengthen the clinical data packages we plan to submit to European and Canadian regulatory authorities later this year.”
Read the Insmed press release.
