Connect Biopharma (CNTB) Study result summary

Study objectives and design

• The Seabreeze STAT Phase 2, randomized, double-blind study evaluated rademikibart as an add-on for acute asthma exacerbations in adolescents and adults with type 2 inflammation and eosinophil count ≥300 cells/μL, enrolling 160 patients primarily from Serbia and Georgia.

• 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.

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

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

• Demographics were balanced; mean age ~55 years, majority White, with similar baseline eosinophil counts and exacerbation history.

Key efficacy results

• Rademikibart achieved a 66% reduction in treatment failure at 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 vs 120 mL with placebo, p=0.023) was observed and maintained through Day 28.

• FEV1 improvement at Day 7 was a pre-specified key secondary endpoint, aligning with FDA interest in rapid benefit for acute indications.

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

• Time to treatment failure favored rademikibart, with higher probability of remaining event-free through Day 28.

Safety and tolerability

• Rademikibart was well-tolerated, with a safety profile comparable to placebo and low incidence of adverse events; no new safety signals observed.

• No episodes of hypereosinophilia or deaths were reported; no adverse events led to study discontinuation.

• Most common adverse events included injection site erythema and urinary tract infection, with no individual event occurring in more than 2 participants.

• Serious adverse events were rare and similar between groups.