According to Insmed, the company has decided to focus on European and Canadian studies of its Arikace liposomal amikacin for inhalation and to put a US Phase 3 study on the back burner. The CLEAR-108 (CLinical Evaluation of ARikace) Phase 3 study of Arikace for the treatment of patients with cystic fibrosis is already underway in Europe and Canada, and Insmed says that it will wait for top-line results from that study before proceeding with Arikace for CF in the US. The FDA lifted a clinical hold on Arikace for CF at the beginning of May 2012.
Insmed President and CEO Timothy Whitten explained, “Insmed has determined that its current resources will be applied towards the CLEAR-108 phase 3 European and Canadian registrational study of Arikace in patients with Cystic Fibrosis (CF)-related Pseudomonas aeruginosa lung infections, the TARGET-NTM phase 2 trial of Arikace in patients with non-tuberculous mycobacteria (NTM) lung disease and the 9-month dog toxicity study.”
He added, “We believe this Arikace development program prioritizes the most compelling near-term opportunities for Insmed and its shareholders. The CLEAR-108 trial provides Insmed with the earliest opportunity to garner critical phase 3 Arikace data in a broad cystic fibrosis patient population while generating important information on the efficacy and safety of Arikace as compared to the current standard of care. In NTM, Arikace has the opportunity to become a part of standard therapy for a rapidly growing chronic disease that has a high unmet medical need with limited treatment options. We project our current cash position to be sufficient to generate top-line data from the three prioritized Arikace studies.”
The company expects to get top-line data from the CLEAR-108 study by mid-2013 and says that it plans to enroll patients in the Phase 2 TARGET-NTM (Treatment with ARikace to Realize Greater Efficacy Trial) trial by mid-2012.
Read the Insmed press release.
