NEWARK, N.J. and NANJING, China, July 31, 2023 /PRNewswire/ — Biosion USA, Inc. (Biosion), a global clinical-stage R&D biotechnology company, today announced the phase 2 study initiation for the evaluation of BSI-045B, an anti-TLSP mAb, in the treatment of atopic dermatitis (AD) .
“We are pleased to have initiated this important Phase 2 trial, which brings us closer to delivering a new treatment option for patients with atopic dermatitis,” said Hugh M. Davis, Ph.D. Chief Business and Development Officer & President, Biosion USA. “This marks another important clinical milestone for Biosion in our effort to develop more high value treatment options for patients.”
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.
For additional information on this trial (NCT05114889), please visit www.clinicaltrials.gov
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’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.
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 phase-I for 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.