Stephen Pham, Senior Vice President of Avalyn Pharma, presents on the development of inhalation therapies for pulmonary fibrosis. The presentation begins with historical context, noting that inhalation therapy has been used since ancient Egyptian and Indian civilizations. Over the years, pharmaceutical companies have developed various drugs to treat respiratory diseases such as asthma, COPD, and pulmonary arterial hypertension. More recently, companies have leveraged the large surface area of the lungs and rapid pharmacokinetic absorption to deliver drugs for systemic diseases like diabetes and schizophrenia.
Pham highlighted the significant unmet needs in treating airway diseases, particularly pulmonary fibrosis, bronchiectasis, and lung cancer. Pham discusses the challenges in developing inhalation therapies, including selecting the right drug, using the appropriate device, and ensuring patient interaction with the device. Pham emphasises the importance of considering drug formulation, stability, and safety, as well as the selection of suitable devices such as dry powder inhalers, metered dose inhalers, and nebulizers.
Avalyn Pharma is focused on developing innovative inhalation therapies to address these unmet needs. Pham provided background information on pulmonary fibrosis, noting that it is a terminal disease affecting a significant number of patients in the US and Europe. Pham mentioned that Avalyn Pharma is developing inhaled versions of two approved oral drugs, pirfenidone (AP01) and nintedanib (AP02), to treat idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). These inhaled formulations aim to reduce systemic exposure and improve tolerability while maintaining or enhancing efficacy.
Pham also discussed the usability of the eFlow nebulizer, which Avalyn Pharma selected for its proven track record and similarity to FDA-approved devices. Results from clinical studies are shared, including Phase 1 and Phase 1B trials, which showed promising results in terms of safety, plasma pharmacokinetics, and airway tolerance. The company plans to conduct further studies to validate these findings and continue developing these therapies to meet the needs of patients with pulmonary fibrosis.