2023-09-05 08:42:44 ET
Insmed Incorporated ( NASDAQ: INSM ) added ~7% pre-market Tuesday after announcing that a Phase 3 trial for its antibiotic Arikayce reached the main goal in adults with a type of bacterial lung infection.
The Phase 3b placebo-controlled trial involved adults with nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC) who had not started antibiotics.
According to the company, the ARISE study met its primary endpoint, indicating that a clinical measure called Quality of Life-Bronchiectasis (QOL-B) respiratory domain works effectively as a patient-reported outcome ( PRO ) instrument.
However, the trial was not powered to show a statistically significant difference between treatment arms.
In terms of safety, discontinuation rates stood at ~23% in the Arikayce arm and ~8% in the comparator arm. Meanwhile, ~92% of those on Arikayce reported treatment-emergent adverse events compared to ~80% in the comparator arm.
The company intends to use data from ARISE and its ongoing ENCORE trial to seek full U.S. approval for Arikayce, which the FDA cleared in 2018 as a combination therapy for MAC lung disease under accelerated approval.
Insmed ( INSM ) expects to propose QOL-B respiratory domain PRO as a primary endpoint for the ENCORE study, which is expected to enroll 250 patients by the end of 2023.
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Insmed gains as antibacterial agent hits main goal in Phase 3 trial