Insmed Incorporated (INSM) completed patient enrollment in the randomized, placebo controlled phase II study on its lead candidate, Arikace. The study is evaluating Arikace for treating patients suffering from recalcitrant nontuberculous mycobacterial (:NTM) lung disease in the U.S. and Canada.
Measurement of the change in the mycobacterial density semi-quantitatively on a seven-point scale from baseline (day one) to the end of the randomized portion of the trial on day 84 is the primary efficacy endpoint of the study. Insmed expects to report top-line results from the study by the end of the first quarter of 2014.
The U.S. Food and Drug Administration (:FDA) granted qualified infectious disease product and fast track designations to Arikace for the treatment of NTM lung infections. Additionally, in Apr 2013, the FDA rendered orphan drug designation to Arikace for NTM.
Insmed has also started the Scientific Advice Working Party procedure with the European Medicines Agency (:EMA) relating to Arikace for NTM lung disease. Discussions between the EMA and Insmed are expected by year end.
Furthermore, Arikace is under phase III development for the treatment of pseudomonas aeruginosa (Pa) lung infections in patients suffering from cystic fibrosis (CF).
In Jul 2013, Insmed reported encouraging results from a phase III study on Arikace for the treatment of Pa in CF patients, when compared to Novartis’ (NVS) TOBI (tobramycin inhalation solution). Detailed data from the study is expected to be presented at a medical conference by Dec 31, 2013.
The company is currently enrolling patients for a two-year open-label extension study on Arikace for the same indication. The extension study is expected to be completed by mid 2015. Insmed intends to seek approval of the candidate in the CF indication in Europe and Canada in the first half of next year. Moreover, Insmed also has plans to seek U.S. approval for Arikace in the CF and NTM indications.
Insmed currently carries a Zacks Rank #4 (Sell). Currently, companies which look attractive include Actelion Ltd. (ALIOF) and AMAG Pharmaceuticals, Inc. (AMAG) with a Zacks Rank #1 (Strong Buy) and a Zacks Rank #2 (Buy), respectively.