Rademikibart Slashes COPD Exacerbations by 85% in Phase 2, FDA Talks Next
CNTB is trading near its 52-week low of $0.98 (5.1% above the low).
Summary
Connect Biopharma's rademikibart, an anti-interleukin-4-receptor alpha (IL-4Rα) antibody, showed an 85% reduction in moderate-to-severe COPD exacerbations through one month in the Phase 2 Seabreeze STAT COPD Study, with a 100% reduction in hospitalizations or ED visits and an 81% reduction in treatment failure rate. The trial enrolled 159 participants worldwide with an eosinophil count of at least 300 cells/μL and a history of acute COPD exacerbations, who received a single subcutaneous dose of rademikibart or placebo alongside standard care. The primary endpoint measured treatment failure within 28 days, defined as death, hospital readmissions, emergency department visits for worsening symptoms, or the need for intensified pharmacologic care. Secondary endpoints assessed changes in clinical respiratory symptoms, post-bronchodilator FEV1, and adverse event incidence over an eight-week period; patients receiving rademikibart required fewer rescue inhalers between the second and seventh weeks and showed a 70 mL improvement in FEV1 at Week 4 compared to placebo. The drug was well tolerated with fewer adverse events than placebo and no new safety signals through the end of the study. This is a new indication beyond the asthma data reported two weeks ago, and the company plans to engage the FDA for a Phase 3 program in COPD. Shares rose 25% to $1.24 on Wednesday following the COPD data, after the stock fell 32% when the asthma data missed its primary endpoint. Cash runway is about one year, so Phase 3 funding will be a key question.
Updated with a Benzinga report · What changed
Updates
· Benzinga — Shares rose 25% to $1.24 on Wednesday following the COPD data.
- Efficacy Results — Patients receiving rademikibart required fewer rescue inhalers between the second and seventh weeks and showed a 70 mL improvement in FEV1 at Week 4 compared to placebo.
- Safety — No new safety signals were observed through the end of the study, and the rademikibart group reported fewer adverse and serious adverse events overall.
- Trial Design
- The trial enrolled 159 participants worldwide.
- Patients had an eosinophil count of at least 300 cells/μL and a history of acute COPD exacerbations.
- Researchers administered a single subcutaneous dose of rademikibart or placebo alongside standard care.
- The primary endpoint measured treatment failure within 28 days.
- Treatment failure included death, hospital readmissions, emergency department visits for worsening symptoms, or the need for intensified pharmacologic care.
- Secondary endpoints assessed changes in clinical respiratory symptoms, post-bronchodilator FEV1, and adverse event incidence over an eight-week period.
All 12 details
- Rademikibart is an anti-interleukin-4-receptor alpha (IL-4Rα) antibody.
- The study is named Phase 2 Seabreeze STAT COPD Study.
- The trial enrolled 159 participants worldwide.
- Patients had an eosinophil count of at least 300 cells/μL and a history of acute COPD exacerbations.
- Researchers administered a single subcutaneous dose of rademikibart or placebo alongside standard care.
- The primary endpoint measured treatment failure within 28 days.
- Treatment failure included death, hospital readmissions, emergency department visits for worsening symptoms, or the need for intensified pharmacologic care.
- Secondary endpoints assessed changes in clinical respiratory symptoms, post-bronchodilator FEV1, and adverse event incidence over an eight-week period.
- Patients receiving rademikibart required fewer rescue inhalers between the second and seventh weeks.
- At Week 4, participants showed a 70 mL improvement in forced expiratory volume (FEV1) compared to the placebo group.
- Researchers observed no new safety signals through the end of the study.
- The rademikibart group reported fewer adverse and serious adverse events overall.
At the time of this announcement, CNTB was trading at $1.03 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $62.5M. The 52-week trading range was $0.98 to $3.82. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: Reuters.