Aerami Therapeutics said that pre-clinical and Phase 1 data presented recently at ATS support advancing the company’s AER-901 nebulized imatinib into a Phase 2 trial that will include both patients with pulmonary arterial hypertension (PAH) and patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). The company said that it expects to initiate the Phase 2 trial in mid-2023.
Aerami was initially developing AER-901 only for the PAH indication but recently expanded its development program to include PH-ILD. The inhaled imatinib received Orphan Drug designation for the PAH indication in August 2021.
According to Aerami, a Phase 1 trial of AER-901 that was initiated in June 2021 “demonstrated a predominantly mild and transient adverse event profile consistent with inhalation products,” with cough and throat irritation the most frequent adverse events. The company said that it would present complete results from the Phase 1 trial at a future meeting. In addition to the Phase 1 data, the company reported that a rat study demonstrated that rats receiving AER-901 via inhalation had 10 times higher lung exposure than rats that received oral imatiinib.
Aerami Executive Chairwoman Anne Whitaker commented, “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. The positive results strongly support our path forward into Phase 2.”
Read the Aerami Therapeutics press release.
