Global, clinical-stage biotech company Biosion, dedicated to developing antibody-based therapies for immune and oncologic diseases, has announced receiving approval from the US Food and Drug Administration (FDA) to initiate a Phase II clinical study for its thymic stromal lymphopoietin (TSLP) monoclonal antibody (mAb) BSI-045B. The in-house developed BSI-045B is intended to treat atopic dermatitis (AD), severe asthma, and other eosinophil and Th2 immune-related diseases.
Phase I Study Results and Phase II Study Design
A clinical Phase I study has demonstrated that BSI-045B exhibits excellent single-dose activity, favorable pharmacokinetic characteristics, and good safety in the treatment of atopic dermatitis patients. Building on these results, the Phase II study is designed to assess the efficacy of BSI-045B either as a standalone treatment or in combination with Dupixent (dupilumab) for atopic dermatitis.
Global Clinical Development and Partnerships
In addition to the clinical study in AD in the US, Biosion’s partner Chia Tai Tianqing is conducting a Phase II study in severe asthma in China. Chia Tai Tianqing holds development and commercialization rights to BSI-045B (TQC2731) in Greater China, indicating a strategic global approach to advancing this potential therapy for immune-related diseases.-Fineline Info & Tech
