Aerami Therapeutics Announces Expansion of the AER-901 (inhaled imatinib) Development Program in Pulmonary Hypertension Supported by Phase 1 Clinical Trial Data and Continued Progress

• 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 (NCT04903730) strongly support progression of AER-901 into Phase 2 development for PAH and PH-ILD, targeted for initiation in 2023
  

DURHAM, N.C., Feb. 23, 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 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 Ms Lisa Yañez, Chief Executive Officer of Aerami. “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.”

“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 Dr Oksana Shlobin, 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 (NCT04903730) 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.

Dr Gary Burgess, consultant Chief Medical Officer to Aerami 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.”

About AER-901

AER-901 is a drug-device combination that is designed to deliver potentially reverse-remodeling therapy with imatinib deeply and efficiently throughout the diseased tissue of the lung via the FOX® nebulizer, a handheld device which 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.

About Pulmonary Arterial Hypertension (PAH)
PAH is a rare and progressive form of pulmonary hypertension characterized by high blood pressure in the arteries of the lungs due to their narrowing or a blockage. PAH affects approximately 70,000 patients in the United States and Europe. Pulmonary vascular remodeling leads to narrowing and obstruction of small pulmonary arteries that increases pulmonary arterial pressure, which makes the heart work harder as it pumps blood through the lungs, eventually leading to right heart failure and, ultimately, death. Currently approved therapies primarily mediate vasodilation and lung or heart-lung transplantation is the only definitive treatment. Median survival remains approximately 5-7 years.

About Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)
Interstitial lung disease (ILD) is an umbrella term for a number of conditions that cause inflammation and scarring (fibrosis) within the tissues of the lung. Approximately 10-15% of individuals with ILD may be diagnosed with pulmonary hypertension (PH-ILD, World Health Organization [WHO] Group 3 PH). Like PAH, PH-ILD is a serious condition characterized by high blood pressure in the arteries of the lungs. Similarly, pulmonary vascular remodeling, associated with inflammation, fibrosis, and hypoxia, is believed to play an important role in PH-ILD development and progression. Currently there is only 1 approved treatment for PH-ILD and estimated survival is less than 5 years.

About Aerami Therapeutics
Aerami is a clinical stage biopharmaceutical company dedicated to breathing life into the treatment of serious and rare cardiopulmonary conditions. Aerami’s mission-driven approach to product development draws seeks to help patients live longer and live better by combining precision medicines and advanced administration platforms to support ease-of-use and quality-of-life.

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.

Aerami Investor and Media Contact:
Joshua Ziel, PhD
VP, Program Development
jziel@aerami.com

Released February 23, 2023