Aerami Therapeutics Announces Presentation of Phase 1 Clinical Trial Data for Lead Program AER-901 at the 2023 European Respiratory Society (ERS) International Congress
DURHAM, N.C., Sept. 12, 2023 (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 results from the randomized double-blind, placebo-controlled Phase 1 clinical trial (NCT04903730) of AER-901 at the 2023 European Respiratory Society (ERS) International Congress. The ERS International Congress is being held September 9-13, 2023, at the MiCo convention center in Milan, Italy. The oral presentation and e-poster are available through the conference portal and will be posted to the Aerami website following the meeting.
AER-901, a proprietary liquid formulation of imatinib for inhalation delivered by a breath activated, high-performance, handheld, smart nebulizer, is in development to address the unmet medical need for people with serious and rare forms of pulmonary hypertension, including the lead indication, pulmonary hypertension associated with interstitial lung disease (PH-ILD), as well as pulmonary arterial hypertension (PAH). In animal models of pulmonary hypertension, imatinib reversed the proliferative, fibrotic, and inflammatory pulmonary vascular remodeling process that is believed to drive symptom severity, disease progression, and outcomes in many forms of the disease. In a Phase 3 clinical trial sponsored by Novartis, oral imatinib demonstrated substantial efficacy when added to 2 or 3 background standard-of-care medications for PAH. However, the efficacious oral doses were poorly tolerated with an unacceptable safety profile. By targeting administration of AER-901 directly to the lung, nonclinical data suggest that an approximate 10-fold dose reduction relative to oral imatinib is appropriate.
Clinical data presented at the 2023 ERS International Congress include safety, tolerability, and pharmacokinetic results from the AER-901 Phase 1 trial. The trial enrolled 84 healthy volunteers and included single ascending dose and multiple ascending dose studies, as well as a cross-over study that compared AER-901 with oral imatinib. Once- and twice-daily dosing with an additional formulation were also evaluated.
Highlights from the presentation include:
“The data from our Phase 1 clinical trial demonstrate that the AER-901 drug-device combination can efficiently deliver imatinib directly to the lung with a potentially improved systemic safety profile,” said Dr. Gary Burgess, Aerami’s Chief Medical Officer. “These data are consistent with our hypothesis that AER-901 has the potential to achieve efficacy with improved safety and tolerability relative to oral imatinib, and we believe that they strongly support the design of our planned platform Phse 2 trial, uniPHied, which will enroll people with either PH-ILD or PAH.”
About the uniPHied Trial
About Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)
About Pulmonary Arterial Hypertension (PAH)
About Aerami Therapeutics
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 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.
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