Aerami Therapeutics to Present New Lung Deposition Data for AER-901 at ATS 2024

Aerami Therapeutics, a biopharmaceutical company focused on treating serious and rare cardiopulmonary diseases, announced upcoming presentations at the American Thoracic Society (ATS) 2024 International Conference in San Diego. The presentations will detail the latest developments of AER-901, a liquid formulation of imatinib designed for inhalation through a smart nebulizer.

One key presentation will showcase new lung deposition modeling data, comparing AER-901's deposition with a hypothetical dry powder inhaled (DPI)-imatinib. This comparison involves subjects with pulmonary hypertension associated with interstitial lung disease (PH-ILD) and pulmonary arterial hypertension (PAH), as well as healthy volunteers. These data were generated by FLUIDDA, Inc., utilizing their Functional Respiratory Imaging (FRI) and Rapid Deposition Analysis (RDA) platforms.

Additionally, Aerami will present on the innovative design of the "uniPHied" platform Phase 2 trial. This trial aims to rapidly evaluate AER-901 across multiple pulmonary hypertension cohorts, initially focusing on PH-ILD and PAH. Gary Burgess, MD, Chief Medical Officer of Aerami, emphasized the significance of the new lung deposition modeling data in supporting AER-901's potential to reverse vascular remodeling in pulmonary hypertension. He also highlighted the strategic importance of the uniPHied trial design for accelerating the development of new therapies for pulmonary hypertension with high unmet medical needs.

The ATS conference presentations are scheduled as follows:
- "Functional Respiratory Imaging and Rapid Deposition Analysis Predict Enhanced Lung Deposition of Imatinib With the AER-901 Inhalation System in Pulmonary Hypertension," will be presented on May 19, 2024, from 11:30 AM to 1:15 PM at San Diego Convention Center, Area F (Hall A-B2, Ground Level).
- "uniPHied: A Novel Platform Study Design for a Phase 2 Clinical Trial to Assess the Safety and Efficacy of AER-901 in Pulmonary Hypertension Associated With Interstitial Lung Disease and Pulmonary Arterial Hypertension," will be presented on May 20, 2024, from 11:30 AM to 1:15 PM at San Diego Convention Center, Area A (Hall A-B2, Ground Level).

AER-901 aims to deliver imatinib therapy deep into lung tissues efficiently. It comprises a liquid formulation of imatinib for inhalation, administered via a high-performance, handheld, smart nebulizer that controls the flow rate and offers real-time feedback to optimize lung deposition. AER-901 is under clinical development for PH-ILD and PAH, two severe forms of pulmonary hypertension with limited treatment options.

PH-ILD is a complication of interstitial lung disease (ILD), affecting over 80,000 individuals in the US, Europe, and Japan. ILD leads to inflammation and fibrosis in lung tissue, and PH-ILD involves high blood pressure in the lung arteries due to vascular remodeling. This remodeling process is characterized by the narrowing and obstruction of small pulmonary arteries, increasing pulmonary arterial pressure and causing the heart to work harder, which can eventually lead to right heart failure. Currently, only one FDA-approved treatment exists for PH-ILD, with an estimated survival rate of less than five years.

PAH is a rare, progressive form of pulmonary hypertension affecting around 70,000 people in the US and Europe. It predominantly impacts women during mid-life and involves high blood pressure in the lung arteries due to narrowing or blockages. Like PH-ILD, PAH is driven by pulmonary vascular remodeling, which affects symptoms and disease progression. Although existing treatments mainly mediate vasodilation, median survival remains approximately 5-7 years.

Aerami Therapeutics is committed to developing treatments for serious and rare cardiopulmonary conditions. The company combines precision medicines with advanced administration platforms to enhance patients' quality of life and ease of use.