Connect Biopharma Reports Topline Phase 2 Asthma Results

What Happened
On September 15, 2026, Connect Biopharma filed an 8-K and issued a press release announcing topline results from a global, randomized, double‑blind, placebo‑controlled Phase 2 study of rademikibart as an add‑on for acute exacerbations in adults and adolescents with asthma and type 2 inflammation. The study enrolled 160 patients (randomized 1:1; rademikibart n=79, placebo n=81) who received a single 600 mg subcutaneous dose plus standard of care. The primary endpoint was treatment failure within 28 days; the key secondary (and proposed Phase 3 primary) endpoint was absolute change from baseline in post‑bronchodilator FEV1 at Week 1.

Key Details

• FEV1 (Day 7 / Week 1): rademikibart improved post‑bronchodilator FEV1 by 250 mL vs 120 mL for placebo — a 130 mL greater improvement (p = 0.023).
• Treatment failure (28 days): rademikibart reduced treatment failures by ~66% versus placebo, but this endpoint did not reach statistical significance (p = 0.153) due to a lower‑than‑expected overall event rate.
• Healthcare visits: ~50% reduction in emergency department visits or unscheduled medical visits for worsening asthma symptoms versus placebo.
• Safety: rademikibart was well tolerated with a safety profile comparable to placebo — low incidence of adverse events, no AEs leading to discontinuation, one SAE in the rademikibart arm vs three SAEs in placebo.
• Next steps: Company expects COPD Phase 2 topline data later this month and plans to meet with the FDA to seek alignment on a Phase 3 program. Press release and corporate presentation were filed as Exhibits 99.1 and 99.2.

Why It Matters
The statistically significant improvement in lung function (FEV1) is a clear positive signal for rademikibart’s effect on acute asthma exacerbations and supports the company’s proposed Phase 3 endpoint. However, the study missed statistical significance on its pre‑specified primary endpoint (treatment failure) because fewer treatment failures occurred than projected, which is an important caveat for assessing overall clinical benefit. For investors, the key near‑term catalysts are the upcoming COPD Phase 2 readout and planned FDA discussions to define a Phase 3 path; these will influence development timeline, regulatory risk, and the potential commercial outlook. The filing also includes standard forward‑looking statement cautions.