- Expansion of the AER-901 development program to include pulmonary hypertension associated with interstitial lung disease (PH-ILD) builds on the company’s existing program in pulmonary arterial hypertension (PAH).
- PH-ILD shares clinical and pathophysiological features with PAH, however, there is only one currently approved therapy in PH-ILD and unmet need remains high.
- Aerami believes that results of the recently completed AER-901 phase 1 trial strongly support progression of AER-901 into phase 2 development for PAH and PH-ILD, targeted for initiation in 2023.
Aerami Therapeutics, a clinical stage biopharmaceutical company, announced a pipeline update to include development of the company’s lead asset, AER-901 (inhaled imatinib), in PH-ILD. PH-ILD is a devastating form of pulmonary hypertension affecting approximately 80,000 to 100,000 people in the United States and Europe.
“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,” said Lisa Yañez, Aerami CEO. “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.”
Lisa Yañez, Aerami CEO
“Patients with PH-ILD have progressive disease with significant morbidity and high mortality. Unlike PAH, there is currently only one approved therapy for patients with this disease,” said Oksana Shlobin, MD, medical director for the Pulmonary Hypertension Program and Director of Outreach and Education for the Inova Advanced Lung Disease and Transplant Program at Inova Fairfax Hospital. “Given its mechanism of action and mode of administration, I am excited by the potential of AER-901 to address underlying drivers of disease progression and to be working closely with the Aerami team on their phase 2 program.”
Aerami recently completed a Phase 1 clinical trial of AER-901 in healthy volunteers and will use the data, now available, as part of planned updates to the open AER-901 Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA) to support phase 2.
“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," said Gary Burgess, Aerami consultant chief medical officer. "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.”
AER-901 is a drug-device combination that is designed to deliver potentially reverse-remodeling therapy with imatinib efficiently throughout the diseased tissue of the lung via the FOX nebulizer, a handheld device that uses a mechanical flow regulator to control the patient’s inhalation flow. AER-901 is in development under an exclusive global license from Vectura Group plc and the FOX nebulizer is both 510(k) cleared and CE marked. A version of the FOX nebulizer is currently in use in Europe as part of another drug-device combination for the treatment of PAH.
