Insmed initiates patient screening for ARIKACE phase 2 NTM lung disease trial

Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, today announced that it has begun screening patients for its U.S. phase 2 clinical trial, Treatment with ARIKACE to Realize Greater Efficacy Trial (TARGET-NTM), of ARIKACE® (liposomal amikacin for inhalation) in patients with non-tuberculous mycobacterial (NTM) lung disease.

There have been very few clinical trials to support current NTM treatment recommendations, and no new drugs have been assessed in randomized trials for NTM lung disease in many years.   Additionally, NTM remains a significantly under-diagnosed disease.  TARGET-NTM represents an opportunity to make significant advancement in the awareness and treatment of this debilitating chronic illness, according to Kenneth N. Olivier, M.D., M.P.H., Principal Investigator of the study and staff pulmonologist in the Laboratory of Clinical Infectious Diseases at the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

"Current treatment for NTM lung disease requires lengthy multi-drug regimens that can be poorly tolerated and have limited efficacy, especially in patients with severe disease or in those who have failed prior treatment attempts," said David E. Griffith, M.D., lead author of the American Thoracic Society's and the Infectious Disease Society of America's diagnosis and treatment guidelines for NTM, and Professor of Medicine at the University of Texas Health Science Center at Tyler. "If effective, ARIKACE has the potential to significantly impact the current NTM treatment paradigm."  Dr. Griffith, along with Richard J Wallace, M.D., Professor of Medicine and Microbiology, also at the University of Texas Health Science Center at Tyler, are Co-Principal Investigators for the study.

NTM Increasingly Prevalent

According to a recent company sponsored patient chart study conducted by Clarity Pharma Research, approximately 50,000 patients suffering from NTM lung disease visited physician offices in the U.S. during 2011.  More than half of these patients were treated with antibiotics for NTM.   This reflects a much larger patient population than previous Insmed estimates.

Patients in the trial will have lung infections with Mycobacterium avium complex (MAC) or Mycobacterium abscessus, which account for approximately 75 percent to over 85 percent of all patients with NTM lung disease in the U.S. 

Treatment with ARIKACE to Realize Greater Efficacy Trial (TARGET-NTM)

• Randomized, placebo-controlled study of ARIKACE in approximately 100 adult patients with recalcitrant NTM lung disease.
• Patients will continue with their antibiotic regimen, and receive additionally, either ARIKACE 560 mg or placebo, delivered once daily via an optimized, investigational eFlow® Nebulizer System (PARI Pharma GmbH).
• Primary efficacy endpoint will be change in mycobacterial density from baseline to the end of 84 days of treatment, which is the end of the randomized portion of the trial.
• At the conclusion of the randomized portion of the study, eligible patients may receive ARIKACE 560 mg once daily for an additional 84 days in an open-label design. Open-label means the patient will know they are receiving ARIKACE.

Patient dosing is expected to begin in mid-2012, with top-line results for the randomized portion of the trial projected in the fourth quarter of 2013.  The clinical trial design has been agreed upon by Insmed and the U.S. Food and Drug Administration.  For more information on the clinical trial, visit www.clinicaltrials.gov.

Also, as recently announced, Insmed has begun dosing patients in CLEAR-108, a European and Canadian registrational phase 3 clinical study of ARIKACE in CF patients with Pseudomonas aeruginosa lung infections, and is proceeding with CLEAR-110, a follow-on multi-cycle open-label study intended primarily to measure safety and tolerability for patients who complete CLEAR-108. 

SOURCE Insmed Incorporated