AeroRx Therapeutics, LLC. and HCmed Innovations Co., Ltd. have announced a strategic collaboration to develop what could become the first nebulized LABA/LAMA combination solution for chronic obstructive pulmonary disease (COPD) treatment. The partnership, announced in October 2022, addresses a significant unmet medical need for COPD patients who cannot effectively use conventional dry powder inhalers.
Targeting Underserved COPD Population
The collaboration focuses on developing a nebulized combination formulation that could benefit 7-19% of the COPD population. This patient group is characterized by moderate to severe airflow obstruction, which creates difficulties in achieving the inspiratory flow rate required to use most dry powder inhalers optimally. According to market reports cited by the companies, there are expected to be close to 34.5 million COPD patients worldwide by 2028, with global treatment sales potentially reaching $19.3 billion.
Strategic Partnership Structure
Under the partnership agreement, AeroRx will be responsible for formulation development, clinical trials, and commercialization of the drug product. HCmed will handle the customization of its AdheResp breath-actuated nebulizer platform, analyzing and optimizing the formulation's aerosol characterization performance to accommodate various stages of the drug development process and the final combination product.
The project will follow a 505(b)2 regulatory pathway, with the corresponding pharmacokinetic/pharmacodynamic (PK/PD) study expected to be conducted with HCmed's nebulizer in 2023.
Industry Leadership and Technology Innovation
Jason Cheng, CEO and founder of HCmed, emphasized the partnership's potential impact: "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 nebulizer 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."
Keith Ung, President and co-founder of AeroRx, expressed similar enthusiasm: "We too are enthusiastic about this partnership. Breath-actuated vibrating mesh delivery of inhaled therapeutics is the wave of the future for many therapeutics and HCmed has become one of the leaders in this elegant inhaler device technology."
Company Backgrounds and Capabilities
HCmed Innovations, founded in 2014, operates as a contract development and manufacturing organization providing vibrating mesh nebulizer technology and services to support global pharmaceutical partners in developing drug-nebulizer combination products for inhalation therapy. The company's customizable mesh nebulizer platform enables efficient and reliable nebulization of different types of medication, ranging from small molecule synthetics to large molecule biologics, as either solutions, suspensions, or even difficult-to-deliver high viscosity drugs.
AeroRx Therapeutics, founded in 2022, is a spin-off of iPharma Lab's inhalation CDRO business, which was recently acquired by Kindeva Drug Delivery in June 2022. The company is developing proprietary inhaled products for the treatment of COPD and asthma, led by industry veterans with extensive expertise in inhaled drug delivery and development.
