Insmed Incorporated (Nasdaq: INSMD), a biopharmaceutical company, announced today that the Company's Investigational New Drug Application (IND) to conduct a pivotal Phase 3 clinical trial of ARIKACE™ (liposomal amikacin for inhalation) in nontuberculous mycobacteria (NTM) lung infections has been cleared by the U.S. Food and Drug Administration (FDA).
In 2010, Insmed initially submitted a regulatory filing to FDA requesting clearance to proceed with a Phase 2 clinical trial for ARIKACE in NTM. FDA responded by suggesting that the Company could change the proposed Phase 2 trial to a primary efficacy study. Based on this feedback, Insmed submitted its IND seeking FDA clearance to initiate a Phase 3 clinical trial of ARIKACE in NTM earlier in the first quarter of this year.
Development of the clinical program aimed at NTM infections was done in partnership with the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health. According to Kenneth Oliver, M.D., M.P.H., staff pulmonologist in the NIAID Laboratory of Clinical Infectious Diseases, current NTM treatment requires lengthy multi-drug regimens that can be poorly tolerated and are often not very effective, especially in patients with severe disease or in those who have failed prior treatment attempts.
No new drugs have been assessed for NTM in a significant number of years. The sustained-release formulation of ARIKACE allows for targeting of the drug to the lungs and the site of disease.
"FDA clearance of our IND to conduct a pivotal Phase 3 clinical trial for ARIKACE in NTM is a critical step in continuing to advance our development plan for this compound," said Renu Gupta, M.D., Executive Vice President Development & Chief Medical Officer of Insmed. "We continue to expect that patient accrual will begin in our Phase 3 clinical trials of ARIKACE in NTM, as well as in the cystic fibrosis Pseudomonas lung infections indication, in the second half of this year. Data in both indications are expected during the first half of 2013."