Biopharmaceutical company, Insmed Incorporated, has reported that the company is continuing its phase II clinical trial proceedings of Arikace (liposomal amikacin for inhalation) in patients with non-tuberculous mycobacteria (NTM) lung disease, as well as the previously planned European registration phase III clinical study of Arikace in Cystic Fibrosis (CF) patients with Pseudomonas aeruginosa (Pa) lung infections.

Simultaneously, Insmed continues its discussions with the US Food and Drug Administration (FDA) regarding the clinical hold previously placed on the Arikace clinical study in CF patients with Pa lung infections.

Arikace is delivered by an investigational eFlow Nebulizer System developed by PARI Pharma and optimized specifically for Arikace. The optimized device uses eFlow Technology to enable highly efficient aerosolization of medication including liposomal formulations via a vibrating, perforated membrane that includes thousands of laser drilled holes.

“I am pleased to announce that we are moving forward with the Arikace clinical development programme in NTM in the US, and with the European CF programme,” said Timothy Whitten, president and CEO of Insmed. “We look forward to continuing our dialogue with FDA regarding the CF clinical programme in the US, and continue to believe that Arikace has the potential to be an important treatment option for CF and NTM patients.”

The phase II clinical trial for Arikace in NTM patients will consist of a randomized, placebo-controlled study of approximately 100 adult patients with recalcitrant NTM lung disease. Patients who are NTM culture positive will continue with their antibiotic treatment regimen, and receive additionally, either Arikace 560 mg, delivered once daily via an optimized, investigational eFlow Nebulizer System (PARI Pharma GmbH), or placebo once daily. The primary efficacy endpoint will be change in mycobacterial density from baseline to the end of 84 days of treatment. At the conclusion of the randomized portion of the study, eligible patients will receive Arikace 560 mg once daily for an additional 84 days in an open-label design, primarily to measure longer-term safety and efficacy. The clinical trial design was previously agreed upon by Insmed and FDA. The company expects to begin enrolling patients in the phase II clinical trial in mid-2012.

The European study in CF patients with Pa lung infections will be a randomized, phase III trial comparing Arikace 560 mg, delivered once daily via an optimized, investigational eFlow Nebulizer System, to TOBI (inhaled tobramycin solution), which is a marketed inhaled antibiotic that is delivered twice daily. The Company anticipates that the study will be conducted in approximately 300 patients. The primary endpoint will be change in pulmonary function (FEV-1) measured after three 28 day on-treatment and three 28 day off-treatment cycles (about six months). A key secondary endpoint will be time to pulmonary exacerbation. The study design was previously agreed upon by Insmed and the European Medicines Agency.  Eligible patients will have the option to participate in a longer term open-label safety study. The company expects to begin enrolling patients in the phase III European clinical study in the second quarter of 2012.

Insmed Incorporated is a biopharmaceutical company focused on the development of innovative inhaled pharmaceuticals for the site-specific treatment of serious lung diseases, and has a proprietary protein platform aimed at niche markets with high unmet medical need.