Connect Biopharma Holdings Limited (NASDAQ:CNTB) (Connect Biopharma, Connect or the Company), a clinical-stage biopharmaceutical company focused on transforming care for the treatment of inflammatory diseases, today announced topline results from its global phase 2 study evaluating rademikibart, the Company’s next-generation, potentially best-in-class anti-interleukin-4-receptor alpha (IL-4Rα) antibody as an add-on treatment for acute exacerbations in adult and adolescent participants with asthma and type 2 inflammation.

"Topline data from our Seabreeze STAT asthma trial for rademikibart supports its potential to meaningfully improve outcomes for patients in the critical period after an exacerbation," said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma. "Today’s data highlight the statistically significant rapid improvements in FEV1 within one week post treatment as well as a 66% reduction in treatment failures at 28 days, although that endpoint did not reach statistical significance. The overall results of this study provide a clear roadmap for design of a Phase 3 program. Taken together with updated market research showing approximately 1.6M ED visits in 2025 for acute asthma exacerbation by high-T2 patients, we believe these results support the potential of rademikibart to deliver significant patient impact and reduce the health economic burden for patients and hospitals. Looking ahead, we intend to report topline data from our Phase 2 Seabreeze STAT chronic obstructive pulmonary disease (COPD) trial later this month. Following which we plan to engage with the FDA regarding a Phase 3 registrational development program for rademikibart as add-on treatment for acute exacerbations of asthma and COPD."

"Patients who experience acute exacerbations remain at an elevated risk for subsequent exacerbations and worsening of symptoms despite current standard-of-care," said Michael Wechsler, MD, Director of the Cohen Family Asthma Institute and Professor of Medicine at National Jewish Health in Denver, Colorado. "66% reduction in treatment failure is an exceptional outcome and is particularly impressive and shows a meaningful improvement over standard-of-care therapy alone. The ability to deliver this magnitude of benefit while also significantly improving lung function underscores the potential of rademikibart to improve outcomes and establish a new treatment paradigm for managing acute exacerbations in the hospital setting."

The Phase 2 Seabreeze STAT Asthma study (CBP-201-206) is a randomized, double-blind, placebo-controlled study that evaluated the safety and efficacy of rademikibart as an adjunct to standard of care for acute exacerbations in adult and adolescent participants with asthma and type 2 inflammation. The study enrolled 160 patients who were randomized 1:1 to receive either a 600mg dose of rademikibart (n=79) or placebo (n=81), administered subcutaneously in addition to standard of care. The primary endpoint was treatment failure, defined as death due to any cause, (re)admission to a hospital for asthma, emergency department (ED) (re)visit or unscheduled medical visit for worsening of asthma symptoms, or the necessity to intensify pharmacologic treatment within 28 days after randomization. The key secondary endpoint was absolute change from baseline in post-bronchodilator (post-BD) forced expiratory volume in one second (FEV1) at Week 1, which is also the proposed primary endpoint for Phase 3.

Key topline results include:

  • Rademikibart demonstrated a statistically significant increase from baseline in post-bronchodilator FEV1 on Day 7 of 250 mL compared to 120 mL with placebo (130mL greater improvement compared to placebo; p=0.023)
  • Rademikibart reduced the treatment failure rate by approximately 66% over 28 days compared to placebo (p=0.153).
    • The endpoint missed statistical significance due to an overall lower treatment failure rate than projected
  • 50% reduction in emergency department visits or unscheduled medical visits for worsening asthma symptoms compared to placebo
  • Rademikibart was well tolerated and no new safety signals were observed through the end of the study. The safety profile was comparable to placebo, with a low incidence of adverse events (AEs) in both arms, no individual AE occurring in more than 2 participants, no AEs leading to study discontinuation in either arm, and one serious adverse event (SAE) reported in the rademikibart arm compared to 3 SAEs in the placebo arm.

     

Connect expects to report topline data from the ongoing Phase 2 Seabreeze STAT COPD study (CBP-201-207) of rademikibart for the treatment of acute exacerbations in COPD patients with type 2 inflammation later this month and plans to move quickly to meet with the FDA to gain alignment on a Phase 3 program.