Connect Biopharma (CNTB) Study result summary

Study objectives and design

• Phase 2, randomized, double-blind, placebo-controlled trial evaluated rademikibart as add-on for acute asthma exacerbations in adolescents and adults with eosinophil count ≥300 cells/μL and ≥1 exacerbation in prior year.

• 160 participants were randomized 1:1 to receive a single 600mg dose of rademikibart or placebo subcutaneously, with a 4-week assessment and follow-up period; demographics were balanced, mean age ~55 years, majority White.

• Patients received aggressive standard-of-care therapy, including systemic steroids and bronchodilators.

• Enrollment was faster in Eastern Europe due to healthcare system structure and limited biologic availability.

• Primary endpoint was treatment failure rate at 28 days (death, hospital/ED visit, or need for intensified treatment); key secondary endpoint was change in post-bronchodilator FEV1 at Day 7.

Key efficacy and safety results

• Rademikibart reduced treatment failure rate by 66% over 28 days compared to placebo (2.5% vs 7.4%), though not statistically significant (p=0.153) due to low event rates.

• Statistically significant and clinically meaningful improvement in post-bronchodilator FEV1 at Day 7: 250 mL increase vs. 120 mL with placebo (p=0.023), maintained through Day 28.

• 50% reduction in emergency department or unscheduled medical visits for worsening asthma symptoms compared to placebo.

• Rademikibart was well-tolerated, with fewer adverse events and serious adverse events than placebo; no deaths, no discontinuations due to adverse events, and no cases of hypereosinophilia.

• Safety profile supports further development for both acute and chronic indications.

Regulatory and development strategy

• Plans to propose Day 7 FEV1 improvement as the Phase 3 endpoint for acute indication, pending FDA discussion.

• Bridging study underway to evaluate IV rademikibart for acute exacerbations; both IV and subcutaneous routes considered for Phase 3.

• Phase 3 program expected to start within 3-4 months after FDA meeting, with data anticipated in 1.5-2 years.

• China partner's Phase 3 asthma study expected to conclude in Q1, with regulatory timelines for atopic dermatitis and asthma outlined.

• Topline data from the Phase 2 COPD study of rademikibart expected later this month.