At the European Cystic Fibrosis Conference in Hamburg, Germany, Insmed presented data showing that Arikace liposomal amikacin for inhalation improved lung function in CF patients over six cycles of treatment. Each cycle included 28 days in which patients received doses of Arikace, followed by 56 days off therapy, and the total period was 72 weeks.
The product also produced a statistically significant reduction in Pseudomonas aeruginosa density that was also sustained over all six cycles. No unexpected adverse events were reported.
“These results further strengthen the clinical data package Insmed is developing for ARIKACE in the treatment of CF patients,” said Renu Gupta, Insmed Executive VP of Development and Chief Medical Officer; “The data are also indicative of why we are so excited to begin our Phase 3 clinical program in the CF indication, which we expect to initiate in the second half of this year. For potential registration of ARIKACE in the US, we intend to conduct a placebo-controlled clinical trial, and for European registration, we intend to conduct a trial that compares ARIKACE to Novartis Corporation’s TOBI. Results from these studies are anticipated in the first half of 2013.”
Read the Insmed press release.
