Avalyn Begins Phase 1b Trial for Inhaled Nintedanib AP02

Avalyn Pharma Inc., a company based in Cambridge, Massachusetts, has initiated a Phase 1b clinical study to evaluate a new inhaled formulation of the drug nintedanib, known as AP02. This study focuses on understanding the safety, tolerability, and pharmacokinetics of AP02 in healthy adult volunteers. The medication is designed to specifically target the lungs and is intended to provide a potential new therapy for individuals suffering from pulmonary fibrosis.

The clinical study comprises both single-ascending dose (SAD) and multiple-ascending dose (MAD) trials. In a previous Phase 1a trial involving both healthy volunteers and patients with idiopathic pulmonary fibrosis (IPF), AP02 demonstrated good tolerability with no serious adverse events reported. Furthermore, AP02 showed lower systemic exposure compared to the oral version of nintedanib, which is already approved for use.

Lyn Baranowski, the CEO of Avalyn Pharma, emphasized the significance of this new study, describing it as a pivotal step towards offering a new inhaled treatment option for patients afflicted with pulmonary fibrosis. Baranowski noted the urgent need for safe and effective treatments that patients can tolerate over the long term. She stated that the results from the Phase 1a study are promising and that the team is eager to further assess the pharmacokinetic profile of AP02 to guide future clinical trials.

The study is randomized, double-blind, and placebo-controlled, meaning that participants will be randomly assigned to receive either AP02 or a placebo without knowing which one they have received. The primary goal is to monitor the incidence, frequency, and severity of any adverse events. Secondary objectives include measuring various pharmacokinetic parameters through blood and bronchoalveolar fluid samples.

Dr. Michael Kreuter, a renowned pulmonologist and a member of Avalyn’s Steering Committee for AP02, expressed optimism about the early clinical results. He emphasized the need for effective treatments that patients can tolerate for extended periods, as current options are limited by significant toxicities. Dr. Kreuter is hopeful that the Phase 1b study will further establish AP02's potential as an innovative inhaled therapy, providing meaningful benefits to patients with pulmonary fibrosis.

Avalyn Pharma is a biopharmaceutical company dedicated to developing inhaled therapies for rare respiratory diseases, including pulmonary fibrosis and other interstitial lung diseases (ILD). Pulmonary fibrosis is characterized by the scarring of lung tissue, a decline in lung function, reduced exercise capacity, and decreased quality of life, all of which contribute to increased mortality. Although current treatments can slow the progression of the disease, they come with significant side effects that limit their use and dosage.

In addition to AP02, Avalyn's lead program is AP01, an optimized inhaled version of pirfenidone. AP01 has shown improved efficacy and safety over existing therapies in clinical trials involving 150 individuals with various forms of pulmonary fibrosis. The company's goal is to develop new inhaled formulations of approved medications that minimize systemic exposure while providing targeted treatment to the lungs.

In summary, Avalyn Pharma's new study on AP02 represents a significant advancement in the quest for more effective and tolerable treatments for pulmonary fibrosis. The results of this study will help inform future clinical trials and potentially bring new hope to patients suffering from this challenging condition.

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