DENVER, Colo. (247marketnews.com) — Connect Biopharma (NASDAQ:CNTB) delivered a potentially important clinical catalyst today, announcing positive preliminary topline results from its global Phase 2 Seabreeze STAT COPD study evaluating rademikibart as an add-on treatment for acute exacerbations in adults with COPD and type 2 inflammation. The company reported an 81% reduction in treatment failure, an 85% reduction in new moderate-to-severe COPD exacerbations, and a 100% reduction in new emergency-department visits or hospitalizations for new exacerbations through four weeks versus placebo, with statistically significant p-values for all three measures. Rademikibart was also reported to have been well tolerated, with fewer adverse events and serious adverse events than placebo and no new safety signals.
The results are particularly notable because acute COPD exacerbations can create a vulnerable period for patients following an emergency visit or hospitalization. Connect CEO Barry Quart called the findings “overwhelming evidence of the potential benefit” of early rademikibart treatment and said the company plans to engage with the FDA regarding a potential Phase 3 registrational program. The company also reported reductions in rescue-inhaler use and improvements in COPD symptoms, while post-bronchodilator FEV1 showed a clinically meaningful 70 mL greater improvement at Week 4 versus placebo, although that particular comparison was not statistically significant (p=0.1607).
The Phase 2 study enrolled 159 participants with COPD, type 2 inflammation and eosinophil counts of at least 300 cells/μL. While the topline results are encouraging, they remain preliminary Phase 2 data, and the company still needs to discuss the development path with regulators and potentially conduct a larger Phase 3 program before any broader regulatory conclusions can be drawn. That distinction will be important for investors as the market weighs the magnitude of today’s clinical signal against the remaining development, regulatory and commercial risks.
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