Aires Pharmaceuticals has signed an agreement with Duke University, US, to provide support for a Phase 2 clinical study of the company’s AIR001 product in patients with heart failure with preserved ejection fraction (HFpEF).

Aires is a fully owned subsidiary of biopharmaceutical company Mast Therapeutics.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The multicentre, randomised, double-blind, placebo-controlled study, known as the Inorganic Nitrite Delivery to Improve Exercise Capacity in HFpEF (INDIE-HFpEF) study, will be conducted on 100 patients.

INDIE-HFpEF will be sponsored by Duke Clinical Research Institute (DCRI), which is a part of Duke University School of Medicine, as the coordinating centre for the Heart Failure Clinical Research Network (HFN), established by National Heart, Lung, and Blood Institute (NHLBI), Maryland, US.

"INDIE-HFpEF’s primary endpoint will be the VO2 after four weeks of treatment with nebulised inhaled AIR001 or placebo as assessed by CPET performed at peak drug levels."

The study will be conducted at around 20 clinical centres, which are part of HFN, in the US.

INDIE-HFpEF’s primary endpoint will be the peak oxygen consumption (VO2) after four weeks of treatment with nebulised inhaled AIR001 or placebo as assessed by CPET performed at peak drug levels.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Secondary objectives of the study cover evaluation of whether AIR001 improves submaximal activity tolerance chronically, quality of life and chronic filling pressures as assessed by echocardiography and natriuretic peptide levels.

The objectives also include ventilator efficiency or submaximal exercise capacity at peak drug levels, and evaluation of the safety and tolerability of AIR001.

Under a previous agreement with the HFN Coordinating Centre, Mast Therapeutics will provide test materials, nebulisers, and regulatory, technical and additional financial support to the proposed study.

Mast Therapeutics said that HFpEF is a usual form of heart failure that has not responded, as well to previously tested treatments as heart failure with reduced ejection fraction.

AIR001 is a sodium nitrite solution that is given in intermittent inhalation via nebulisation, and was acquired by Mast Therapeutics in 2014 through the purchase of then privately held Aires Pharmaceuticals.

The company recently documented positive results from a blinded and randomised Phase 2a clinical study of AIR001 in 30 patients with HFpEF conducted at Mayo Clinic.