Lung & Respiratory Breakthroughs: ALYFTREK Approval, IPF Trial Milestones, PAH Advancements and more
This week on Lung and Respiratory Health Updates, we dive into six major developments shaping the future of care in cystic fibrosis, idiopathic pulmonary fibrosis (IPF), pulmonary arterial hypertension (PAH), COVID-19, and nontuberculous mycobacterial (NTM) lung infections.
From EU approval of ALYFTREK—the broadest CFTR modulator to date—to promising new targets in IPF and game-changing FDA reviews in PAH, these updates are critical for medical professionals, researchers, and biotech innovators driving progress in respiratory care.
💊 ALYFTREK Approved in EU as Broadest CFTR Modulator
Vertex’s once-daily triple therapy—deutivacaftor, tezacaftor, vanzacaftor—wins European Commission approval for CF patients aged six and above with at least one non-class I mutation. Around 31,000 individuals across the EU are now eligible.
🫁 GRI Bio Completes Phase 2a IPF Trial Enrollment
GRI-0621, which targets iNKT cells to slow fibrosis, showed safety and tolerability at two and six weeks. Biomarker results are due soon, with topline data expected in Q3 2025.
❌ Pliant Ends Bexotegrast Development After Unfavorable Safety Data
Despite early FVC promise, safety concerns in the BEACON-IPF trial prompted program discontinuation. Pliant shifts focus to oncology and early-stage candidates.
🫀 Merck’s Winrevair Receives FDA Priority Review in PAH
The ZENITH trial showed a seventy-six percent reduction in major morbidity and mortality events. The study was halted early due to overwhelming efficacy. An expanded label may soon follow.
🧒 Shionogi Files for Pediatric Use of Ensitrelvir in COVID-19
The sNDA seeks approval for children aged six and older, weighing at least 20 kilograms. Phase 3 data showed efficacy and safety consistent with adult populations. A 25 mg pediatric formulation was also submitted.
🔬 Shionogi and BioVersys Partner to Advance Anti-NTM Lung Infection Therapy
The global collaboration targets BV500, an ansamycin-based oral therapy. With CHF 5 million upfront and up to CHF 479 million in milestones, this program tackles rising antimicrobial resistance in NTM.
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