Pharmaceutical Business review

AeroRx, HCmed to develop nebulised combination formulation for COPD

AeroRx will involve in the formulation development, clinical studies, and commercialisation of the drug product. Credit: MasterTux from Pixabay.

The new combined formulation will be delivered using a breath-actuated nebuliser.

Currently, AeroRx is said to be engaged in the development of the first nebulised LABA/LAMA combination solution that is anticipated to be beneficial for 7-19% of the COPD population.

As part of the partnership, AeroRx will take responsibility for the formulation development and clinical studies, as well as the drug candidate commercialisation.

HCmed will involve in the customisation of the AdheResp breath-actuated nebuliser platform besides enhancing the formulation’s aerosol characterisation performance to accommodate different stages of the drug development process and the final combination product.

Besides following a 505(b)2 regulatory pathway, the project will include a corresponding PK/PD study that will be carried out with HCmed’s nebuliser next year.

HCmed CEO and founder Jason Cheng said: “We are excited to announce our partnership with AeroRx. 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 nebuliser platform.

“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.”

HCmed Innovations is a contract development and manufacturing organisation that offers vibrating mesh nebuliser technology and services, while AeroRx Therapeutics develops inhaled products to treat COPD and asthma.

As per the market reports, COPD patients are expected to reach around 34.5 million across the world by 2028.