Insmed Reports First Quarter 2017 Financial Results And Provides Business Update

Advancing Toward Top-Line Results from CONVERT Study in 2H 2017

Conference call today at 8:30 AM ET

BRIDGEWATER, N.J., May 03, 2017 (GLOBE NEWSWIRE) -- Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, today reported financial results for the quarter ended March 31, 2017 and provided a business update.

Business Update

• Advancing toward top-line data for phase 3 CONVERT study in the second half of 2017. The CONVERT study, or INS-212, is evaluating ARIKAYCE^® (liposomal amikacin for inhalation, or LAI) in treatment refractory nontuberculous mycobacteria (NTM) lung disease caused by Mycobacterium avium complex (MAC). The primary efficacy endpoint is the proportion of subjects who achieve culture conversion at Month 6 in the LAI plus multi-drug regimen arm compared to the multi-drug regimen without LAI arm.
• Plan to initiate a phase 2 dose-ranging study of INS1007 in non-cystic fibrosis (non-CF) bronchiectasis in the second half of 2017. INS1007 is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase I (DPP1), an enzyme responsible for activating neutrophil serine proteases in neutrophils when they are formed in the bone marrow. Insmed is also evaluating the potential of INS1007 in other indications. Plans to initiate any phase 2 studies are pending dialogue with the FDA.

"We remain focused on the execution of the phase 3 CONVERT study of LAI in NTM lung disease and on nonclinical activities for INS1007 as a treatment for non-CF bronchiectasis in preparation for the planned initiation of a phase 2 dose-ranging study,” said Will Lewis, president and chief executive officer of Insmed. “As we advance toward our top-line results for the CONVERT study in the second half of 2017, we are also making progress in our regulatory and pre-commercial plans to support LAI. We continue to be committed to a disciplined use of capital while carrying out these important clinical, pre-commercial and operational activities.”

First Quarter Financial Results