HCmed has announced the start of a strategic partnership with global biotherapeutics company CSL Behring to collaboratively develop CSL Behring's plasma-derived immunoglobulin administered via HCmed's new generation vibrating-mesh nebulising device (CSL787).
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Under the terms of the agreement, CSL Behring will have sole responsibility for the development and commercialisation of the combination product, with HCmed leading the development of the customised nebulising device specifically optimised for CSL Behring's formulation.
The CSL787 Phase I clinical trial has commenced, with the first subject dosed in December 2020. This study is a prospective, multicenter, randomised, double-blind, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics and exploratory efficacy of nebulised CSL787 after administration of single and multiple ascending doses in healthy subjects and subjects with non-cystic fibrosis bronchiectasis.
Commenting on the partnership, Jason Cheng, the CEO of HCmed, said: "It further validates our proprietary nebuliser platform AdheResp, which transforms the delivery of biologics from an intravenous to an inhalation route, thereby better reaching the respiratory tract. This breakthrough application is capable of delivering inhaled antibodies, peptides, and proteins. Our platform can be customised to enhance drug delivery for a range of formulations and adjusted to meet specific performance requirements. The vision is to provide a new highly-efficient treatment device for patients who suffer from chronic respiratory diseases and to improve their treatment adherence and quality of life."