Connect Biopharma reports Phase 2 asthma data for rademikibart

Connect Biopharma Holdings Limited announced topline results on September 15, 2026 from its global Phase 2 study of rademikibart used as an add-on treatment for acute exacerbations in adult and adolescent participants with asthma and type 2 inflammation.¹

The trial, known as Seabreeze STAT Asthma (CBP-201-206), enrolled 160 patients randomized 1:1 to a 600mg dose of rademikibart (n=79) or placebo (n=81), each given subcutaneously alongside standard of care.¹ The primary endpoint was treatment failure, defined as death from any cause, hospital readmission for asthma, an emergency department revisit, an unscheduled medical visit for worsening symptoms, or the need to intensify pharmacologic treatment within 28 days after randomization.¹

On the key secondary endpoint, rademikibart showed a statistically significant rise from baseline in post-bronchodilator FEV1 at Day 7, gaining 250 mL versus 120 mL for placebo, a 130 mL difference (p=0.023).¹ On the primary endpoint, the drug reduced treatment failure by about 66% over 28 days compared with placebo (p=0.153), missing statistical significance because the overall failure rate came in lower than projected.¹ The company also reported a 50% drop in emergency department visits or unscheduled medical visits for worsening asthma symptoms versus placebo.¹

On safety, the company said rademikibart was well tolerated with no new safety signals, a profile comparable to placebo, no single adverse event occurring in more than two participants in either arm, no discontinuations due to adverse events, and one serious adverse event in the rademikibart arm versus three in the placebo arm.¹

Connect said it expects to report topline data from its ongoing Phase 2 Seabreeze STAT COPD study (CBP-201-207) later in September 2026, and plans to meet with the FDA to seek alignment on a Phase 3 program.¹ Connect has an exclusive license agreement with Simcere Pharmaceutical Co., Ltd. for rademikibart in Greater China, under which Connect is eligible for up to approximately $99 million in milestone payments plus tiered royalties up to low double digits on net sales in that territory.¹