Aerami Therapeutics today announced positive data supporting its inhaled imatinib for treating pulmonary hypertension (PH).
Studies of AER-901 support progression into a Phase 2 clinical trial. Data backed Aerami’s treatment for both PH associated with interstitial lung disease (PH-ILD) and pulmonary arterial hypertension (PAH).
AER-901 is a drug-device combination. Aerami designed it to deliver potentially reverse-remodeling imatinib therapy deeply and efficiently throughout diseased tissue of the lung. Delivery takes place through a high-performance, handheld, smart nebulizer. It controls flow rates and provides patients with real-time feedback to optimize lung deposition.
Aerami presented data at the 2023 American Thoracic Society (ATS) International Conference. Findings included pharmacokinetic outcomes in rats receiving a single dose of oral imatinib mesylate or pulmonary administration of AER-901.
About the Aerami study
Key findings demonstrated nearly 10-fold higher lung exposure with pulmonary administration compared with equivalent oral imatinib. By targeting the lung, data suggests the effective AER-901 dose is potentially 10 times lower than the original oral dose, according to a news release. Standard oral doses studied in PH total between 200 mg and 400 mg.
The completed Phase 1 trial evaluated the safety, tolerability and pharmacokinetics of low inhaled doses. It compared those doses to placebo in more than 80 participants. The study included single and multiple ascending dose studies, evaluating doses from 5 mg to 80 mg, Aerami said.
AER-901 demonstrated a predominantly mild and transient adverse event profile consistent with inhalation products, the company said. Cough and throat irritation — consistent with inhaled products — constituted the most frequent adverse events.
Aerami wants AER-901 to address a “critical unmet medical need” for people with the serious and rare forms of PH. The company plans to update its open investigational new drug (IND) application with the FDA. It aims to initiate a Phase 2 proof-of-concept clinical trial in mid-2023.
“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 chair of the board of directors at Aerami. “The positive results strongly support our path forward into Phase 2.”
