Insmed Completes Enrollment of Phase 2 Clinical Trial of ARIKACE to Treat Nontuberculous Mycobacteria Lung Disease in U.S. and Canada - Seite 2

Patients in the trial are stratified for either Mycobacterium avium complex (MAC) infections or Mycobacterium abscessus infections. These pathogens collectively account for approximately 85% percent of all patients with NTM lung disease in the U.S. Additionally, stratification is performed based on patients with cystic fibrosis versus those who do not have cystic fibrosis.

Certain secondary, tertiary and exploratory endpoints being measured include, but are not limited to, time to sputum conversion, change in clinical signs and symptoms, change in patient related outcomes/quality of life and safety.

The Company has completed recruitment with 90 patients in the trial as required per protocol. The Company has concluded that the study was sufficiently powered to achieve statistical significance with 80% power to demonstrate a one-step change in the seven-step scale measuring bacterial density, as specified in the protocol.

"We are very pleased to have completed enrollment in this important clinical trial of ARIKACE to treat recalcitrant NTM lung infections," stated Renu Gupta, M.D., Executive Vice President Development and Chief Medical Officer of Insmed. "This is the first controlled clinical trial of an antibiotic in patients suffering from NTM lung disease. There are no FDA-approved treatments in this serious and increasingly prevalent infectious disease, and current treatment regimens include multiple antibiotics that must be given for prolonged periods of time, are often poorly tolerated and can be associated with severe toxicities. Sadly, for many patients, these therapies are often inadequate with few alternative treatment options available."

"Completing enrollment of this trial is a major accomplishment for Insmed, particularly given the challenge of enrolling patients who have completed six months on ATS/IDSA guideline therapy. The current tolerability challenges of the guideline therapy limit the practical utility of the ATS/IDSA recommended treatment regimen and are the reason why approximately half of diagnosed NTM patients do not receive or continue to take the recommended off label therapies," stated Will Lewis, President and Chief Executive Officer of Insmed.