NEWARK, Del. and NANJING, China, April 4, 2023 /PRNewswire/ -- Biosion USA, Inc. (Biosion), a global clinical-stage R&D biotechnology company, today announced that it has successfully opened an IND following review by the U.S. Food and Drug Administration to initiate a Phase 2 clinical trial of BSI-045B, an anti-TSLP monoclonal antibody (mAb) for the treatment of atopic dermatitis (AD), severe asthma and other eosinophilic, Th2 immune-related.
"BSI-045B is a next generation anti-TSLP mAb with high affinity and bioactivity that has the potential to offer greater therapeutic potential for patients with AD" said Dr. Hugh Davis, Chief Operating Officer of Biosion, Inc. and President of Biosion USA. "Initiating the phase II clinical trial is an important step toward our goal of developing antibody-based therapeutics for patients with unmet medical needs worldwide"
The phase I study of BSI-045B demonstrated its potential to be a first-in-class treatment for AD due to its single dose activity in a cohort of AD patients, excellent PK and favorable safety profile. The phase II study is designed to assess the efficacy of BSI-045B as monotherapy as well as in combination therapy with Dupixent® to further increase therapeutic effectiveness for patients who are suffering from AD.
In addition to this study, Biosion's collaboration partner - CTTQ, a China-based pharmaceutical company with rights to BSI-045B (TQC2731) for China development and commercialization, is currently conducting a Phase II clinical trial of BSI-045B in China for the treatment of severe uncontrolled asthma.
BSI-045B is a high-affinity, humanized monoclonal antibody, targeting thymic stromal lymphopoietin (TSLP), a cytokine that is implicated in the pathogenesis of atopic dermatitis, asthma and other eosinophilic and Th2 immune-related diseases.
Biosion is a global, clinical-stage biotechnology company committed to developing antibody-based therapies to improve patient outcomes for the treatment of immune and oncologic diseases. Established in 2017, Biosion has built a pipeline of innovative biologics through its internally derived proprietary technologies including the H³ antibody discovery platform, SynTracer® high-throughput endocytosis platform, and Flexibody™ bispecific platform. Biosion's lead asset, BSI-045B (anti-TSLP mAb), is currently in phase-II for severe asthma and atopic dermatitis. Biosion and partners have plans to progress the immune-oncology and antibody drug conjugate-based portfolio into clinical trials for oncology indications over the next year. Biosion has operations in the US, Australia, and China. To learn more about Biosion, please go to www.biosion.com.
Source: Biosion, Inc.