DURHAM, N.C., May 20, 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 the presentation of new lung deposition modeling data for AER-901 at the American Thoracic Society (ATS) 2024 International Conference being held May 17-22, 2024, in San Diego, California.
These new data generated by FLUIDDA, Inc., using their proprietary Functional Respiratory Imaging (FRI) and Rapid Deposition Analysis (RDA) platforms, predicted efficient deposition of AER-901 throughout the lung in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) or pulmonary arterial hypertension (PAH), as well as healthy volunteers. When compared with a hypothetical dry-powder-inhaled imatinib (DPI-Imatinib) at equivalent nominal doses, total imatinib lung deposition with AER-901 was predicted to be more than 2 times greater across all three populations, and deposition in the deep lung was predicted to be more than 3 times greater.
“We believe that these new modeling data, generated in collaboration with FLUIDDA, strongly highlight the differentiated AER-901 profile across multiple forms of pulmonary hypertension,” said Anne Whitaker, Chairwoman and Chief Executive Officer of Aerami. “By optimizing delivery of imatinib to the lungs with AER-901, we believe that we can better target disease drivers in PH-ILD and other forms of pulmonary hypertension, which may translate into an improved efficacy and safety profile at lower doses for patients with these devastating conditions.”
In addition to the new lung deposition modeling data, the innovative and unique design of the “uniPHied” platform clinical trial was presented, which is intended to allow for efficient evaluation of AER-901 in multiple forms of pulmonary hypertension, initially PH-ILD and PAH. As a novel approach, Aerami believes that the uniPHied design could provide a blueprint that may accelerate drug development for high unmet need in multiple forms of pulmonary hypertension.
Copies of both poster presentations are now available on the Aerami website at www.aerami.com.
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
