Aerami Therapeutics to Present New Lung Deposition Modeling Data for AER-901, in Development for Pulmonary Hypertension, at the American Thoracic Society 2024 International Conference

DURHAM, N.C., May 08, 2024 (GLOBE NEWSWIRE) -- Aerami Therapeutics (“Aerami”), a clinical stage biopharmaceutical company dedicated to breathing life into the treatment of serious and rare cardiopulmonary diseases, today announced presentations related to AER-901, a proprietary liquid formulation of imatinib for inhalation administered via high-performance, handheld, smart nebulizer, at the upcoming American Thoracic Society (ATS) 2024 International Conference, taking place May 17-22, 2024, in San Diego, California.   One presentation will feature new lung deposition modeling data comparing the deposition of AER-901 to that of a hypothetical dry powder inhaled (DPI)-imatinib in subjects with pulmonary hypertension associated with interstitial lung disease (PH-ILD) and pulmonary arterial hypertension (PAH), as well as healthy volunteers. These modeling data were generated by FLUIDDA, Inc., using their proprietary Functional Respiratory Imaging (FRI) And Rapid Deposition Analysis (RDA) platforms. In addition, the unique and innovative design of the “uniPHied” platform Phase 2 trial will be presented, demonstrating the optionality to expeditiously evaluate AER-901 in multiple pulmonary hypertension cohorts (initially PH-ILD and PAH)."We are excited to present new lung deposition modeling data that we believe strongly support the differentiation of AER-901 and its potential to reverse the vascular remodeling process central to multiple forms of pulmonary hypertension," said Gary Burgess, MD, Chief Medical Officer of Aerami. "Further, we believe that presentation of the uniPHied platform trial design highlights a differentiated clinical strategy and goal of accelerating development of new therapies for PH-ILD and other forms of pulmonary hypertension with high unmet need."
                     
*Session and Presentation Details:*                      
*Presentation Title:*
Functional Respiratory Imaging and Rapid Deposition Analysis Predict Enhanced Lung Deposition of Imatinib With the AER-901 Inhalation System in Pulmonary Hypertension                      
*Poster Number:* 595                      
*Session:*
A56 - BUZZING THE TOWER: NOVEL DIAGNOSTIC AND MONITORING TOOLS IN PH                      
*Date:* May 19, 2024                      
*Time:* 11:30 AM – 1:15 PM                      
*Location:* San Diego Convention Center, Area F (Hall A-B2, Ground Level)
                       
*Presentation Title:* 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                      
*Poster Number:* 6                      
*Session:* B60 - CYANOTIC PACIFIC BLUE: GROUP 3 PH AND HYPOXIC LUNG DISEASE                      
*Date:* May 20, 2024                      
*Time:* 11:30 AM – 1:15 PM                      
*Location:* San Diego Convention Center, Area A (Hall A-B2, Ground Level)                                              

Abstracts for the presentations are currently available on the ATS 2024 International Conference website and the posters will be made available via the Aerami website following the meeting.*About AER-901*

AER-901 is a drug-device combination that is designed to efficiently deliver imatinib therapy deep into the diseased tissues of the lung. AER-901 is comprised of a proprietary, liquid formulation of imatinib for inhalation that is administered by a breath-activated, high-performance, handheld, smart nebulizer that controls flow rate and provides real-time feedback to help optimize lung deposition. AER-901 is currently in clinical development for people with PH-ILD and PAH, two rare and serious forms of pulmonary hypertension with high unmet medical need for improved treatment options.

*About Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD) *

Interstitial lung disease (ILD) is an umbrella term for several conditions that cause inflammation and scarring (fibrosis) of the lung tissue. Pulmonary hypertension is a serious complication of ILD for more than 80,000 people in the United States, Europe, and Japan, and is characterized by high blood pressure in the arteries of the lungs that is believed to be associated with pulmonary vascular remodeling. Pulmonary vascular remodeling is a proliferative, fibrotic, and inflammatory process that leads to narrowing and obstruction of small pulmonary arteries. Over time, pulmonary vascular remodeling is believed to drive increased pulmonary arterial pressure, which causes the heart to work harder as it pumps blood through the lungs, eventually leading to right heart failure. There is only one FDA-approved treatment for PH-ILD, and estimated survival is less than 5 years.

*About Pulmonary Arterial Hypertension (PAH) *

PAH is a rare and progressive form of pulmonary hypertension characterized by high blood pressure in the arteries of the lungs due to their narrowing or a blockage. PAH, which disproportionately impacts women and frequently during the middle part of their lives, affects approximately 70,000 people in the United States and Europe. As in PH-ILD, pulmonary vascular remodeling is believed to drive PAH symptoms, disease progression, and outcomes. Currently approved treatments primarily mediate vasodilation, and despite advances in therapy, median survival remains approximately 5-7 years.

*About Aerami Therapeutics*

Aerami is a clinical stage biopharmaceutical company dedicated to breathing life into the treatment of serious and rare cardiopulmonary conditions. Aerami’s mission-driven approach to product development seeks to help patients live longer and live better by combining precision medicines and advanced administration platforms to support ease-of-use and quality-of-life. For more information visit our website at www.aerami.com.

This press release contains “forward-looking statements” which include statements, other than statements of historical fact, regarding, among other things: the plans for, or progress, scope, cost, initiation, duration, enrollment, results or timing for availability of results of, development of AER-901 or any other Aerami product candidate or the development of Aerami’s current and planned clinical trials, Aerami’s business development efforts and its expectations regarding its prospects, the planned Phase 2 uniPHied trial for AER-901 in patients with either PH-ILD or PAH, the potential approval and commercialization of AER-901, discussions with the FDA or EMA regarding Aerami’s programs, the potential benefits or competitive position of AER-901, the period for which Aerami’s cash resources will be sufficient to fund its operating requirements (runway), or Aerami’s plans, expectations or future operations, financial position, revenues, costs or expenses. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements, including, but not limited to, uncertainties associated with the clinical development process, including, among other things, the timing, expense, and results of the planned Phase 2 uniPHied trial for AER-901 as well as other clinical trials and regulatory processes, whether favorable findings from the Phase 1 trial for AER-901 to date, pre-clinical profile, pharmacokinetic modeling data, marketing research and other data will be predictive of results from the Phase 2 uniPHied trial or any other clinical trials for AER-901, Aerami’s ability to financially support its drug-device product candidate clinical development programs, the timing and outcome of Aerami’s anticipated interactions with regulatory authorities, Aerami’s ability to obtain coverage, pricing or reimbursement for any approved products in the United States or Europe, delays or other challenges in the recruitment of patients for, or the conduct of, Aerami’s clinical trials, and Aerami’s ability to make required payments under its outstanding convertible notes or any other indebtedness as they come due and Aerami’s ability to obtain additional financing and raise capital as necessary should the product development process become more extended. These statements are made as of the date of this press release. Actual results may vary. Aerami undertakes no obligation to update any forward-looking statements for any reason. Aerami cautions you not to place undue reliance on any forward-looking statement.

*Aerami Investor & Media Contact:*
Chad Whitaker
Aerami Therapeutics
cwhitaker@aerami.com