China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that its drug candidate HSK31858 obtained ethical approval at the First Affiliated Hospital of Guangzhou Medical University. The in-house developed Category 1 drug will be assessed for its efficacy and safety in a multi-center, randomized, double-blind, placebo-controlled Phase II study in non-cystic fibrosis bronchiectasis (NCFBE).
Phase II Study Details
The Phase II study, expected to enroll 210 subjects, will also assess the changes in pharmacodynamic markers related to HSK31858 administration. This comprehensive evaluation aims to further understand the drug’s potential benefits in treating lower respiratory tract diseases.
HSK31858 Profile
HSK31858 is an oral, potent, and highly selective dipeptidyl peptidase 1 (DPP1) small molecule inhibitor with a new mechanism of action. It is being developed to treat lower respiratory tract diseases caused by bronchiectasis and acute lung injury/acute respiratory distress syndrome. Notably, no similar product exists anywhere in the world. The drug has concluded Phase I clinical trials in Australia and China, positioning it for further advancement in clinical development.
Future Implications
The ethical approval for HSK31858 marks a significant milestone in Haisco’s efforts to address unmet medical needs in the treatment of lower respiratory tract diseases. This innovative drug candidate has the potential to offer new therapeutic options for patients suffering from non-cystic fibrosis bronchiectasis and related conditions.-Fineline Info & Tech
