Aer Therapeutics Snags $36 Million in Financing to Develop COPD Therapy

By Alex Keown
April 17, 2023

Aer Therapeutics will advance its experimental inhaled therapeutic for chronic obstructive pulmonary disease (COPD) into Phase I testing following a $36 million infusion of cash.

The Raleigh-based startup raised the funds in a Series A financing round backed by multiple life sciences investors, including Canaan, OrbiMed, and Hatteras Venture Partners. Proceeds from the financing will enable in-human studies of AER-01, the company’s novel inhaled small molecule mucolytic drug designed to liquefy COPD-related mucus plugs in the lungs. The Phase I study is expected to begin later this year, the company announced.

Jim Shaffer, president and chief executive officer of Aer Therapeutics said the company, a spinout of John Fahy’s laboratory at the University of California, San Francisco, is dedicated to developing therapeutics for COPD patients who have severe airway obstruction caused by mucus plugs.

“Our scientific founders led the pioneering research that uncovered mucus plugs as a key mechanism of disease in COPD, and their laboratories worked together to discover AER-01 as a novel mucolytic treatment. Aer will continue to leverage this expertise in the development of AER-01 and other therapeutic candidates for the treatment of muco-obstructive lung diseases,” Shaffer said in a statement.

Our lungs are protected by a mucus gel comprised of mucin glycoproteins. In healthy lungs, the mucus freely moves about. However, in lungs compromised by diseases such as COPD, that mucus no longer moves about freely and can form plugs that obstruct airways. It is estimated that approximately five million COPD patients, between 30% and 50% of severe COPD sufferers in the United States have a mucus plug-high disease subtype. Mucus plugs reduce lung function and diminish quality of life. There are no drugs approved to effectively liquefy mucus plugs, known as mucolytics, in these patients.

Conventional COPD treatments, including bronchodilators and supplemental oxygen, do not treat the airway obstruction caused by mucus plugs. Recent advances in the understanding of mucus plug biology and novel methods of quantifying mucus plugs that use computed tomography have created opportunities to advance drug development intended to eliminate mucus plugs, the company announced Aer Therapeutics is seizing upon these new opportunities to advance AER-01 for COPD.

Developed by Fahy, AER-01 is a thiol-modified carbohydrate designed to cleave mucin disulfide bridges in order to liquefy mucus plugs. AER-01 is a potent and fast-acting mucolytic well-suited for both nebulizer and dry powder delivery. In addition to COPD, Aer Therapeutics believes AER-01 has applications in other lung diseases, including asthma, bronchiectasis, and cystic fibrosis.

“Studies using CT lung scans confirm that mucus plugs are highly prevalent in COPD patients and those with a high mucus plug burden have lower lung function, increased frequency of exacerbations, diminished quality of life, and increased risk of all-cause mortality. These findings provide a basis to specifically treat and remove mucus plugs as a strategy to improve lung health for COPD patients,” said Fahy, professor of medicine at UCSF and founder of Aer Therapeutics. “COPD is a complex disease and one-size-fits-all treatment approaches are not likely to work. The use of CT imaging in the clinical development for AER-01 will help ensure that treatment is targeted to those patients most likely to benefit from an effective mucolytic.”