AeroRx Therapeutics, a spin-off of US-based iPharma Lab's inhalation business and Taiwan-based startup HCmed Innovations have initiated a collaboration, introducing a LABA/LAMA (long-acting muscarinic antagonist/long-acting beta agonist) combination solution for delivery with a breath-actuated nebulizer.

This collaboration sets forth the framework by which both companies will work together to develop a new nebulized combination formulation for the treatment of chronic obstructive pulmonary disease (COPD).

According to market reports, it is estimated that there would be close to 34.5 million COPD patients worldwide by 2028, accounting for treatment global sales that could reach up to $19.3 billion. AeroRx is currently developing the first nebulized LABA/LAMA combination solution, which could benefit 7-19% of the COPD population.

Under this partnership, AeroRx will be responsible for the formulation development, clinical trials, and commercialization of the drug product, while HCmed will be responsible for the customization of the AdheResp breath-actuated nebulizer platform, analyzing and optimizing the formulation's aerosol characterization performance to accommodate the various stages of drug development process and the final combination product. The project will follow a 505(b)2 regulatory pathway, and the corresponding PK/PD study is expected to be conducted with HCmed's nebulizer in 2023.