February 18, 2014
Insmed Incorporated, a biopharmaceutical company focused on developing an inhaled anti-infective to treat patients battling serious lung diseases in orphan indications that are often life-threatening, provides an interim update from the Company’s CLEAR-110 study, an ongoing, two-year, open-label extension study of once-daily ARIKACE®, or liposomal amikacin for inhalation, to treat Pseudomonas aeruginosa (Pa) in cystic fibrosis (CF) patients. These data are from 98 patients who have completed the first 12 months (six cycles) of the CLEAR-110 extension study. The data were collected as part of a scheduled data safety monitoring board (DSMB)
review of the CLEAR-110 extension study. The data showed that ARIKACE was well tolerated,
and there was a sustained improvement from baseline level in Forced Expiratory Volume in One
Second (FEV1). These patients also experienced a sustained reduction in density of Pa sputum
while on treatment.
The Two-Year Open-label Extension Study
Eligible patients from the open-label, multicenter, randomized Phase 3 CLEAR-108 trial (as described below) were given the option to participate in a two-year, open-label, multi-cycle extension study designed to evaluate the long-term safety and tolerability of ARIKACE in CF patients. 206 patients enrolled in this study, representing 77% of the patients that completed the randomized portion of the Phase 3 trial, and received at least one dose of study drug. The data presented in the attached charts and discussed below includes 98 patients who had completed one year in the CLEAR-110 study by December 31, 2013, the time of data cut-off for DSMB review.
These data demonstrate that patients receiving ARIKACE for six cycles (12 months) in the extension study, showed mean increase in relative change in FEV1 which is sustained during both on-treatment and off-treatment months. Overall, ARIKACE was well-tolerated during the six cycles administered over this 12-month period, with adverse events being consistent with those expected in a population of CF patients receiving inhaled medicines.
“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,” said Renu Gupta, MD, FAAP, Executive Vice President Development and Chief Medical Officer of Insmed.
“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,” said Will Lewis, President and Chief Executive Officer of Insmed. “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.”
“I would like to recognize Dr. Gupta and our clinical team for designing and conducting such an important trial. This is the first trial to investigate the safety and efficacy of inhaled antibiotics in CF patients for a period of up to two years and it speaks to Insmed’s ongoing commitment to understanding the safe and effective use of this drug in this target population,” added Mr. Lewis.
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