Connect Biopharma Holdings Limited is a clinical-stage biopharmaceutical company dedicated to discovering and advancing immune modulators. Its primary objective is to develop treatments for serious autoimmune diseases and various inflammatory conditions. The company's lead investigational therapy is CBP-201, an anti-interleukin-4 receptor alpha antibody. This candidate is currently in Phase IIb clinical trials, targeting inflammatory allergic diseases such as atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps. Additionally, Connect Biopharma's pipeline includes CBP-307, a small molecule designed to modulate sphingosine 1-phosphate receptor 1. This receptor plays a crucial role in regulating T cell movement from lymph nodes into the bloodstream. CBP-307 is in Phase II development for treating autoimmune-related inflammatory disorders. Another preclinical-stage asset, CBP-174, is an orally administered small molecule histamine receptor 3 antagonist, being investigated for chronic pruritus (itch) associated with skin inflammation. The portfolio also features CBP-233, a humanized antibody in preclinical development that targets interleukin-33, a cytokine recognized for its involvement in T helper 2 inflammation. Established in 2012, the company maintains its headquarters in Taicang, China.
Connect Biopharma Announces Positive Preliminary Topline Data from its Global Phase 2 Study of Rademikibart as an Add-on Treatment for Acute Exacerbations in Adults with COPD and Type 2 Inflammation
Connect Biopharma announced positive topline data from its global Phase 2 Seabreeze STAT COPD trial of rademikibart as add-on treatment for acute exacerbations in adults with COPD and type 2 inflammation.
Rademikibart reduced treatment failure by 81% (p=0.0122), new moderate-to-severe exacerbations by 85% (p=0.030), and hospitalizations or ED visits by 100% (p=0.0137) through Week 4, with a safety profile comparable to placebo. The 159-participant trial also showed a 70 mL greater improvement in FEV(1) at Week 4 that missed statistical significance (p=0.1607).
The company plans to engage with the FDA to align on a Phase 3 registrational program, and remains eligible for up to approximately $99 million in remaining milestones from its Simcere partnership in Greater China.