Insmed Incorporated has announced that it will go ahead with two clinical trials of its Arikace liposomal amikacin for inhalation for non-tuberculous mycobacteria (NTM) lung disease and for P. aeruginosa infections in CF patients despite the continuing clinical hold placed by the FDA on the latter application.
The FDA lifted the hold on Arikace for NTM earlier this year, and the company plans to begin a Phase 2 trial study with approximately 100 NTM patients by mid-2012. The Phase 3 trial of Arikace for the treatment of P. aeruginosa infections in CF patients, also expected to begin by mid-year, will take place in Europe using a study design approved by the EMA.
Insmed President and CEO Timothy Whitten commented, “I am pleased to announce that we are moving forward with the Arikace clinical development program in NTM in the US and with the European CF program. We look forward to continuing our dialogue with FDA regarding the CF clinical program in the US, and continue to believe that Arikace has the potential to be an important treatment option for CF and NTM patients.”
Read the Insmed press release.
