Insmed Incorporated has two completed, one recruiting, and one soon-to-be recruiting clinical trials using their drug ARIKACE for the treatment of cystic fibrosis patients. ARIKACE is an inhaled liposomal form of amikacin designed to combat infections of Pseudomonas aeruginosa, the most prevalent bacteria among cystic fibrosis patients.
The combined Phase 1/2 trial collected its last data in 2009 and investigated the safety and tolerability of 28 once-a-day doses of nebulized ARIKACE, and one Phase 3 trial (CLEAR-108) collected final data in 2013 and investigated the efficacy of inhaled ARIKACE against inhaled tobramycin solution.
An interim update of the CLEAR-110 study reported that ARIKACE is well tolerated by patients and substantially improves forced expiratory volume in one-second (FEV1). Moreover, the density of P. aeruginosa was reduced in the sputum of treated patients. These results were compiled from 98 patients who completed six cycles of ARIKACE over twelve months by the end of 2013. Patients were a subgroup of Insmed’s Phase 3 CLEAR-108 trial who were given the opportunity to participate in the multi-cycle extension study. “…ARIKACE administered once a day in non-inferior to the standard of care [tobramycin] which is administered twice a day,” stated Renu Gupta, MD, FAAP, Executive Vice President Development and Chief Medical Officer of Insmed, in a news article. “This longer-term study demonstrates our continued commitment to the cystic fibrosis patients and to gathering longer term data to clarify the safety and efficacy profile of our drug candidate.”
Will Lewis, President and Chief Executive Officer of Insmed, also commented on the data: “We are especially pleased that these data demonstrated that patients taking ARIKACE actually saw their FEV1 levels remain above baseline on average. In addition we continue to see reduction of bacterial density and consistency in our overall safety profile. Further, we believe that once-daily administration of ARIKACE will support patient convenience and compliance.”
ARIKACE is convenient in that it requires administration once a day, compared to tobramycin, which is administered twice a day. Even though fewer treatments are required, ARIKACE performs just as well and gave patients an elevated FEV1 relative to baseline, according to the company. Adverse effects were similar between both groups and were as expected in cystic fibrosis patients receiving inhaled antibiotics. Lewis sees the results as encouraging and stated, “With the results achieved in our Phase 3 trial, along with these positive interim data, we continue our preparation for regulatory filings with the European Medicines Agency and Health Canada, which remain on target for mid-year.”
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