Aerami Therapeutics announced that it will develop its AER-901 nebulized imatinib for pulmonary hypertension associated with interstitial lung disease (PH-ILD) in addition to pulmonary arterial hypertension (PAH). The FDA granted orphan drug designation to AER-901 for the PAH indication in August 2021, and the company says that it recently completed a Phase 1 trial of AER-901 that was initiated in June 2021. Aerami is partnered with Vectura on development of AER-901, which is delivered via Vectura‘s Fox handheld vibrating mesh nebulizer.
Aerami CEO Lisa Yañez commented, “Expansion of our AER-901 development program to include PH-ILD demonstrates Aerami’s deepening focus on pulmonary hypertension and commitment to help people with these devastating conditions live longer and better lives. The feedback we have received from clinical experts validates our confidence in the potential for AER-901’s reverse-remodeling mechanism of action in PH-ILD and we believe our Phase 1 data support our goal of initiating Phase 2 development in both PAH and PH-ILD by mid-2023.”
Consultant Chief Medical Officer Gary Burgess said, “We believe that the data from our Phase 1 trial, along with results of our nonclinical studies, strongly support our hypothesis that AER-901 can target delivery of low-dose imatinib to the lung at therapeutic levels while greatly reducing systemic exposures relative to oral imatinib. We believe these data will further differentiate AER-901 from other inhaled tyrosine kinase inhibitors in pulmonary hypertension and will enable us to initiate Phase 2 development.”
Read the Aerami Therapeutics press release.
