Aerami Therapeutics Unveils AER-901 Lung Data at ATS 2024

Aerami Therapeutics, a clinical-stage biopharmaceutical company, announced new findings on AER-901 at the American Thoracic Society (ATS) 2024 International Conference in San Diego. The data, produced by FLUIDDA, Inc. using their Functional Respiratory Imaging (FRI) and Rapid Deposition Analysis (RDA) platforms, demonstrated that AER-901 achieves efficient lung deposition in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) or pulmonary arterial hypertension (PAH), as well as in healthy individuals.

Compared to a hypothetical dry-powder-inhaled imatinib (DPI-Imatinib) at similar doses, AER-901's total lung deposition of imatinib was more than double across all groups, and its deposition in the deep lung was over three times greater. Anne Whitaker, Chairwoman and CEO of Aerami, emphasized that these results underline the unique profile of AER-901 in various forms of pulmonary hypertension. The company aims to optimize imatinib delivery to better target disease drivers in PH-ILD and other types of pulmonary hypertension, potentially leading to improved efficacy and safety at lower doses.

In addition to the deposition data, the conference featured the "uniPHied" platform clinical trial's design, which allows for efficient evaluation of AER-901 across multiple forms of pulmonary hypertension, starting with PH-ILD and PAH. This innovative approach could expedite drug development for conditions with significant unmet needs.

AER-901 is a drug-device combination designed to deliver imatinib deep into the lung tissues. It consists of a liquid formulation of imatinib for inhalation administered via a breath-activated, handheld nebulizer that controls flow rate and provides real-time feedback to optimize lung deposition. AER-901 is in clinical development for PH-ILD and PAH, both serious and rare forms of pulmonary hypertension that require better treatment options.

Interstitial lung disease (ILD) refers to conditions causing lung tissue inflammation and scarring. PH-ILD is a severe complication affecting over 80,000 individuals in the US, Europe, and Japan, characterized by high blood pressure in lung arteries due to pulmonary vascular remodeling. This remodeling involves a proliferative, fibrotic, and inflammatory process that narrows and obstructs small pulmonary arteries, increasing pulmonary arterial pressure and causing the heart to work harder, eventually leading to right heart failure. Currently, there is only one FDA-approved treatment for PH-ILD, with an estimated survival of fewer than five years.

Pulmonary arterial hypertension (PAH) is a rare, progressive form of pulmonary hypertension caused by narrowed or blocked lung arteries, affecting around 70,000 people in the US and Europe. PAH predominantly affects women in their middle years. As with PH-ILD, pulmonary vascular remodeling drives the symptoms and progression of PAH. Existing treatments mainly focus on vasodilation, and despite therapeutic advancements, the median survival is approximately 5-7 years.

Aerami Therapeutics is committed to developing treatments for serious and rare cardiopulmonary conditions. Their mission is to help patients live longer and better lives by integrating precision medicines with advanced administration platforms to enhance ease-of-use and quality of life.