Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AP02 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Placebo BID | PLACEBO_COMPARATOR | Placebo solution for Inhalation |
| AP02 low dose BID | ACTIVE_COMPARATOR | Nintedanib solution for Inhalation |
| AP02 high dose BID | ACTIVE_COMPARATOR | Nintedanib solution for Inhalation |
| Name | Type | Description |
|---|---|---|
| AP02 | DRUG | Oral inhalation solution |
| Placebo | DRUG | Placebo oral inhalation solution |
Inclusion Criteria: * Male or female patients aged ≥40 years at the time of signing the written informed consent form * Diagnosis of idiopathic pulmonary fibrosis (IPF) as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/ Asociación Latinoamericana de T...
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AP02 is an investigational small molecule developed by Avalyn Pharma Inc. for idiopathic pulmonary fibrosis, a progressive lung disease. It is a nintedanib solution given by inhalation and is currently in Phase 2 clinical development. AP02 has not been approved by the FDA and remains under study.
AP02 is being evaluated for the treatment of idiopathic pulmonary fibrosis (IPF), a chronic and progressive scarring disease of the lungs. It is an inhaled formulation of nintedanib designed for direct delivery to the lungs. AP02 is investigational and has not been approved for any indication.
AP02 targets PDGFR, FGFR, and VEGFR, three receptor tyrosine kinase families involved in fibroblast proliferation and angiogenesis. By inhibiting these pathways, AP02 is designed to interfere with the fibrotic processes that drive IPF. Nintedanib, the active agent in AP02, is a known multi-kinase inhibitor.
AP02 is being developed by Avalyn Pharma Inc., a biopharmaceutical company focused on inhaled therapies for pulmonary diseases. Avalyn Pharma trades under the ticker AVLN. The company is the sole sponsor of the ongoing Phase 2 trial for AP02.
AP02 is in Phase 2 clinical development. The only trial listed for AP02 is a Phase 2 study, and no Phase 3 trials have been initiated. AP02 is investigational and has not received FDA approval.
AP02 is being studied in the AURA-IPF trial, a randomized, double-blind, placebo-controlled Phase 2 study. The trial identifier is NCT07194382 and it is currently recruiting. It plans to enroll 160 participants with idiopathic pulmonary fibrosis across Australia, Canada, Germany, New Zealand, Spain, Turkey, and the United Kingdom.