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FDA lifts hold on second trial of Insmed's Arikace

Monday, May 07 2012 | Comments
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Insmed Inc. said the Food and Drug Administration lifted the clinical hold previously placed on a Phase III trial investigating Arikace (liposomal amikacin) for inhalation in patients with cystic fibrosis (CF) who have Pseudomonas lung infections.

The FDA and Insmed agreed on a revised CF clinical trial population that includes adults who have chronic Pseudomonas lung infections and a percent predicted forced expiratory volume in one second between 25 percent and 75 percent.

Insmed is still finalizing with the regulatory agency details of the study protocol for the potential Phase III clinical trial. The company said it is also evaluating what to do next with the U.S. Arikace CF clinical program, given the current progress and "anticipated resource requirements" of the drug's ongoing programs in CF and nontuberculous mycobacteria (NTM) lung disease. 

In January, the FDA lifted the clinical hold on Insmed's Phase III study of Arikace in patients with NTM lung disease. 

As previously reported, the FDA initiated the clinical holds on the Arikace programs in NTM and CF based on an initial review of the results Insmed reported from a long-term rat inhalation carcinogenicity study of Arikace.

Last October, the FDA requested that Insmed conduct a Phase II trial of Arikace in adults with NTM to provide proof-of-concept efficacy and safety data before proceeding with a Phase III study. The company is initiating a U.S. Phase II trial of Arikace in NTM.

Additionally, Insmed has started dosing patients in CLEAR-108, a European and Canadian registrational Phase III study of Arikace in patients with CF, and it is proceeding with CLEAR-110, a follow-on, open-label study intended primarily to assess safety and tolerability for patients who complete CLEAR-108.

Insmed shares closed at $4.10, up $1.40, or 51.9 percent, in heavy volume on the Nasdaq.

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