Aerami Therapeutics Announces Pharmacokinetic Data Demonstrating the Potential of AER-901 (Inhaled Imatinib) to Achieve Therapeutic Levels at Low Inhaled Doses for Treatment of Pulmonary Hypertension
DURHAM, N.C., May 24, 2023 (GLOBE NEWSWIRE) -- Aerami Therapeutics (“Aerami”), a clinical stage biopharmaceutical company dedicated to breathing life into the treatment of serious and rare cardiopulmonary conditions, today announced results from studies of AER-901 (inhaled imatinib) that support progression into a Phase 2 clinical trial in both pulmonary hypertension associated with interstitial lung disease (PH-ILD) and pulmonary arterial hypertension (PAH).
The data, presented at the 2023 American Thoracic Society (ATS) International Conference, included nonclinical pharmacokinetic (PK) findings in rats receiving a single dose of oral imatinib mesylate or pulmonary administration of AER-901. In addition, preliminary safety findings from the completed AER-901 Phase 1 clinical trial (NCT04903730) were presented.
Key findings included:
AER-901 is in development to address critical unmet medical need for people with two serious and rare forms of pulmonary hypertension – PAH and PH-ILD. Pulmonary hypertension is a serious complication of ILD for more than 80,000 people in the U.S. and Europe. Only one treatment for PH-ILD is currently approved by the United States Food and Drug Administration (FDA), but estimated survival remains less than 5 years.
PAH, which disproportionately impacts women and frequently during the middle part of their lives, is a rare and progressive disease that affects approxmately 70,000 patients in the U.S. and Europe. Despite advances in therapy, there is no cure for PAH and median survival remains approximately 5-7 years.
“These important data presented at ATS and the full results of Aerami’s completed Phase 1 of AER-901 study mark significant steps forward in the development of AER-901 with the ultimate goal of addressing the critical unmet medical need for patients with PH-ILD and PAH,” said Anne Whitaker, Executive Chairwoman of the Board of Directors at Aerami. “The positive results strongly support our path forward into Phase 2.”
Aerami plans to update the open Investigational New Drug (IND) application with the FDA to initiate a Phase 2 proof-of-concept clinical trial that will enroll patients with either PAH or PH-ILD in mid-2023. Full results for the Phase 1 study in healthy volunteers will be presented at a future meeting.
About Pulmonary Arterial Hypertension (PAH)
About Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)
About Aerami Therapeutics
This press release contains “forward-looking statements” concerning the development and commercialization of Aerami’s product candidates, timing of clinical trials, the company’s business development efforts and its expectations regarding its prospects, including, but not limited to, the timing and outcome of current and planned clinical trials. 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 clinical trials and regulatory processes, the company's ability to financially support its drug-device product candidate clinical development programs, and the timing and outcome of the company's anticipated interactions with regulatory authorities. 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.
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