AeroRx, HCmed Team Up on New Combo of Bronchodilators for COPD
New treatment would be delivered using handheld breath-actuated nebulizer
AeroRx Therapeutics is teaming up with HCmed Innovations to develop a new therapeutic combination of different classes of bronchodilators — medications that help open up the airways, making breathing easier — for the treatment of people with chronic obstructive pulmonary disease (COPD).
The new combo would be delivered using a breath-actuated nebulizer, a handheld device that administers a dose of medicine as a mist when a patient inhales.
Under the partnership, AeroRx will be responsible for the formulation of the COPD bronchodilators, as well as all clinical trials, and the commercialization strategy of the medication. HCmed, meanwhile, will be in charge of customizing the breath-actuated mesh nebulizer platform, called AdheResp. That includes optimizing the aerosol formulation to deliver the medication.
“We are excited to announce our partnership with AeroRx,” Jason Cheng, CEO and founder of HCmed, said in a press release.
“The AeroRx team has extensive experience in the development of respiratory drugs, while at HCmed we can support our partners to develop drug-nebulizer combination products with our proprietary breath-actuated mesh nebulizer platform,” Cheng said.
COPD treatment generally involves the use of bronchodilators. Long-acting beta two agonists (LABAs) and long-acting muscarinic antagonists (LAMAs) are both classes of bronchodilators.
Some LAMA medications include tiotropium (sold as Spiriva Respimat) and aclidinium (sold as Tudorza), while LABA medications include formoterol (sold as Perforomist, among other brand names), and salmeterol (sold as Serevent).
A LAMA/LABA combo
Guidelines from the American Thoracic Society, published in 2020, include a strong recommendation for the use of a combination of LAMA and LABA agents over either therapy alone to treat COPD patients who have shortness of breath or exercise intolerance. This is because the combination of both types of compounds is thought to maximize bronchodilation.
AeroRx is developing a LAMA/LABA solution for COPD patients with moderate to severe airflow obstruction, which it says accounts for 7–19% of the COPD population. These patients have difficulties achieving the inspiratory flow rate that is required to properly use the most common dry powder inhalers.
With the breath-activated nebulizer, a medicine can be inhaled deeply into the lungs and its delivery efficiency increased.
“The product of our collaboration will provide COPD patients with an effective inhaled LABA/LAMA combination drug, which will reinforce patients’ treatment adherence and improve their quality of life,” Cheng said.
Keith Ung, president and co-found of AeroRx, said HCmed “has become one of the leaders” in developing devices that use this new inhaler technology.
“Breath-actuated vibrating mesh delivery of inhaled therapeutics is the wave of the future for many therapeutics,” Ung said.
A study evaluating the pharmacological properties of the new solution, delivered using the AdheResp device, is planned for 2023. The project is anticipated to follow a 505(b)2 regulatory pathway.
This pathway allows therapy manufacturers to obtain approval for a medication based on studies previously conducted by other entities. It provides a faster and less expensive route for approval than traditional regulatory pathways. Companies may apply for this pathway if they develop new therapy formulations, combinations of medications, or different routes of administration that might be more effective than previous versions.