Peptide News Digest

#Arikayce

2 stories

Clinical Trials · View digest

Insmed Presents Phase 3 ASPEN Post-Hoc BRINSUPRI Data in Non-Cystic Fibrosis Bronchiectasis Patients With Prior NTM Infection Plus New TPIP PAH Analysis at ERS Congress Wednesday

Insmed Incorporated (NASDAQ: INSM) presented Wednesday September 9, 2026 at the ERS Congress in Barcelona a post-hoc analysis of the Phase 3 ASPEN trial evaluating BRINSUPRI (brensocatib, a first-in-class oral dipeptidyl peptidase 1 (DPP1) inhibitor approved in August 2025 for non-cystic fibrosis bronchiectasis (NCFB) in ages 12+) in the subgroup of ASPEN patients with prior nontuberculous mycobacterial (NTM) infection. The analysis is one of five Insmed abstracts at the meeting, alongside a COMPERA 2.0 risk-assessment post-hoc analysis of treprostinil palmitil inhalation powder (TPIP) in pulmonary arterial hypertension, additional ARIKAYCE (amikacin liposome inhalation) data on the psychosocial burden and healthcare resource use of MAC lung disease, and treatment-pattern analyses. Brinsupri launched August 2025 via specialty pharmacy in the U.S. and is under EMA and MHRA review with Japanese filing in H2 2026. TPIP is Insmed's mid-stage prostacyclin analog delivered via dry powder inhaler, targeting PAH as a differentiated option relative to United Therapeutics' Tyvaso (nebulized treprostinil).

Clinical Trials · View digest

Insmed Presents Late-Breaking Phase 3b ENCORE ARIKAYCE Data in Newly Diagnosed MAC Lung Disease at ERS Congress Sunday September 6

Insmed Incorporated (NASDAQ: INSM) presented late-breaking Phase 3b ENCORE results for ARIKAYCE (amikacin liposome inhalation suspension) in an oral session Sunday September 6, 2026 at the European Respiratory Society Congress in Barcelona. The 12-month study evaluated ARIKAYCE plus multidrug therapy (azithromycin 250 mg plus ethambutol 15 mg/kg) versus multidrug therapy alone in patients with a new occurrence of Mycobacterium avium complex (MAC) lung infection who had not received antibiotics — a substantially different population from ARIKAYCE's current U.S. label limited to refractory MAC. ENCORE met its primary endpoint of improvement in respiratory symptom score at month 13 and all multiplicity-controlled secondary endpoints; culture conversion at month 6 was 87.8% with ARIKAYCE plus multidrug versus 57.0% with multidrug alone. Insmed plans to file a supplemental new drug application in the second half of 2026 to expand the U.S. label to newly diagnosed MAC lung disease and convert the current accelerated approval in refractory MAC to traditional approval. Five Insmed abstracts total were accepted at the meeting including brensocatib (Brinsupri, DPP1 inhibitor) bronchiectasis analyses.