nintedanib/pirfenidone (AP03) / Avalyn Pharma - LARVOL DELTA

Avalyn Pharma Secures $100 Million in Series D Funding, Pioneering Pulmonary Fibrosis Treatment with Inhalation Therapy (36Kr) - "The funds from this round will primarily support Avalyn's key clinical progress in the field of pulmonary fibrosis treatment. This includes advancing the global Phase IIb clinical trial of its core candidate drug AP01 (inhaled pirfenidone), the late-stage development of AP02 (inhaled nintedanib), and the entry of AP03 (pirfenidone/nintedanib fixed-dose combination) into the Phase I clinical stage."

Commercial • Idiopathic Pulmonary Fibrosis • Interstitial Lung Disease • Systemic Sclerosis

Avalyn Completes Oversubscribed $100 Million Series D Financing to Further Advance Clinical Development of Novel Inhaled Therapies for Pulmonary Fibrosis (GlobeNewswire) - "Avalyn Pharma Inc...announced the closing of an oversubscribed $100 million Series D financing...Proceeds will support key clinical milestones across Avalyn’s pipeline programs in pulmonary fibrosis, including the late-stage development of Avalyn’s lead programs: optimized inhaled formulations of pirfenidone (AP01) and nintedanib (AP02), as well as the advancement of the pirfenidone/nintedanib fixed dose combination (AP03) into Phase 1 clinical trials....The company plans to initiate a Phase 2 clinical trial for AP02 in patients with IPF."

Financing • New P2 trial • Idiopathic Pulmonary Fibrosis

Dose-Dependent Change of Inhaled Pirfenidone Seen in Lung Volume and Fibrosis Quantification in Patients With IPF: A Deep Learning Image-Based Analysis of Data From the ATLAS Phase 1b Trial (ATS 2025) - P1 | "Patients ineligible for, intolerant of, or unwilling to start oral pirfenidone or nintedanib were randomised 1:1 to receive nebulised AP01 50mg QD or 100mg BID for up to 72 weeks... Patients on the higher dose regime of 100mg AP01 showed a smaller lung volume reduction at week 36 and reduced fibrosis progression at week 24 compared to the 50mg dose. There was a trend across both time points to less fibrosis extent progression in the higher dose regime. Deep learning-based imaging biomarkers can be used to quantify dose-dependent effects on disease progression and suggest a dose-dependent effect of AP01 in patients with IPF."

Clinical • P1 data • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology