MONMOUTH JUNCTION, N.J., May 30, 2012 /PRNewswire/ -- Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, today provided a corporate update, including the Company's current strategic development priorities for ARIKACE® (liposomal amikacin for inhalation).
"Insmed has determined that its current resources will be applied towards the CLEAR-108 phase 3 European and Canadian registrational study of ARIKACE in patients with Cystic Fibrosis (CF)-related Pseudomonas aeruginosa lung infections, the TARGET-NTM phase 2 trial of ARIKACE in patients with non-tuberculous mycobacteria (NTM) lung disease and the 9-month dog toxicity study," said Timothy Whitten, President and CEO of Insmed.
"We believe this ARIKACE development program prioritizes the most compelling near-term opportunities for Insmed and its shareholders," continued Mr. Whitten. "The CLEAR-108 trial provides Insmed with the earliest opportunity to garner critical phase 3 ARIKACE data in a broad cystic fibrosis patient population while generating important information on the efficacy and safety of ARIKACE as compared to the current standard of care. In NTM, ARIKACE has the opportunity to become a part of standard therapy for a rapidly growing chronic disease that has a high unmet medical need with limited treatment options. We project our current cash position to be sufficient to generate top-line data from the three prioritized ARIKACE studies."
"Insmed believes that ARIKACE has the potential to address important unmet medical needs in CF and NTM, two key orphan indications with combined global market opportunity of up to $1 billion," concluded Mr. Whitten.Cystic Fibrosis CLinical Evaluation of ARIKACE (CLEAR-108) Phase 3 CF Study
- Randomized, phase 3 trial comparing ARIKACE 560 mg, delivered once daily via an optimized, investigational eFlow® Nebulizer System (PARI Pharma GmbH), to twice daily TOBI®(1) 300 mg (inhaled tobramycin solution), a commercially available inhaled antibiotic delivered via the PARI LC® Plus nebulizer
- Trial is underway in Europe and Canada and will include approximately 300 patients
- Primary endpoint is change in pulmonary function (FEV-1) measured after three 28 day on-treatment and three 28 day off-treatment cycles (approximately six months)
- Key secondary endpoint is time to pulmonary exacerbation
- Top-line data expected in mid-2013
- Randomized, placebo-controlled study of ARIKACE in approximately 100 adult patients that will include two of the most common species of NTM that cause lung disease - Mycobacterium avium complex (MAC) and Mycobacterium abscessus
- NTM culture positive patients will continue with their antibiotic regimen, and receive additionally either ARIKACE 560 mg, delivered once daily via an optimized, investigational eFlow Nebulizer System, or placebo, once daily
- 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 patients will know they are receiving ARIKACE.
- Patient enrollment currently expected to begin in mid-2012, with top-line results projected in the fourth quarter of 2013