Connect Biopharma Initiates Phase 2 Seabreeze STAT COPD Study Evaluating Rademikibart for the Treatment of Acute Exacerbations in COPD
Connect Biopharma (NASDAQ: CNTB) has initiated its Phase 2 Seabreeze STAT COPD study to evaluate rademikibart as a treatment for acute exacerbations in COPD patients. The study, approved by the FDA, will assess the drug's safety and efficacy as an adjunct to standard care in patients with COPD and type 2 inflammation.
The trial will enroll approximately 160 participants globally with acute COPD exacerbation and eosinophil count ≥300 cells/μL. Participants will receive either a single dose of rademikibart or placebo. The primary endpoint will measure treatment failure rate over 28 days following acute exacerbation. The company expects to report topline data in 1H 2026.
This initiative follows promising post-hoc analysis from their Phase 2b Asthma study, showing potential benefits particularly in patients with elevated baseline eosinophil counts. Currently, about 1.3 million patients visit emergency departments annually for COPD flare-ups, with 50% experiencing treatment failure within four weeks.
Connect Biopharma (NASDAQ: CNTB) ha avviato lo studio di Fase 2 Seabreeze STAT COPD per valutare rademikibart come trattamento per le esacerbazioni acute nei pazienti con BPCO. Lo studio, approvato dalla FDA, analizzerà la sicurezza e l'efficacia del farmaco come supporto alla terapia standard in pazienti con BPCO e infiammazione di tipo 2.
La sperimentazione prevede l'arruolamento di circa 160 partecipanti a livello globale con esacerbazione acuta di BPCO e conta eosinofila ≥300 cellule/μL. I partecipanti riceveranno una singola dose di rademikibart o placebo. L'endpoint principale misurerà il tasso di insuccesso del trattamento nei 28 giorni successivi all'esacerbazione acuta. L'azienda prevede di comunicare i dati principali nella prima metà del 2026.
Questa iniziativa segue un'analisi post-hoc promettente del loro studio di Fase 2b sull'asma, che ha evidenziato potenziali benefici soprattutto nei pazienti con elevati livelli basali di eosinofili. Attualmente, circa 1,3 milioni di pazienti si recano ogni anno nei pronto soccorso per riacutizzazioni di BPCO, con il 50% che manifesta insuccesso terapeutico entro quattro settimane.
Connect Biopharma (NASDAQ: CNTB) ha iniciado su estudio de Fase 2 Seabreeze STAT COPD para evaluar rademikibart como tratamiento para exacerbaciones agudas en pacientes con EPOC. El estudio, aprobado por la FDA, evaluará la seguridad y eficacia del medicamento como complemento al tratamiento estándar en pacientes con EPOC e inflamación tipo 2.
El ensayo reclutará aproximadamente 160 participantes a nivel mundial con exacerbación aguda de EPOC y recuento de eosinófilos ≥300 células/μL. Los participantes recibirán una dosis única de rademikibart o placebo. El objetivo principal medirá la tasa de fracaso del tratamiento durante los 28 días posteriores a la exacerbación aguda. La compañía espera reportar datos preliminares en el primer semestre de 2026.
Esta iniciativa sigue a un análisis post-hoc prometedor de su estudio de Fase 2b en asma, que mostró beneficios potenciales especialmente en pacientes con recuentos elevados de eosinófilos en línea base. Actualmente, alrededor de 1.3 millones de pacientes acuden anualmente a urgencias por crisis de EPOC, con un 50% que experimenta fracaso del tratamiento en cuatro semanas.
Connect Biopharma (NASDAQ: CNTB)는 만성 폐쇄성 폐질환(COPD) 환자의 급성 악화를 치료하기 위한 라데미키바트(rademikibart)의 평가를 위해 2상 Seabreeze STAT COPD 연구를 시작했습니다. FDA 승인을 받은 이번 연구는 COPD 및 2형 염증 환자에서 표준 치료에 추가하는 약물의 안전성과 효능을 평가할 예정입니다.
이 임상시험은 전 세계적으로 급성 COPD 악화 및 호산구 수치가 ≥300 세포/μL인 약 160명의 참가자를 모집합니다. 참가자들은 라데미키바트 단회 투여 또는 위약을 받게 됩니다. 주요 평가 지표는 급성 악화 후 28일 동안의 치료 실패율입니다. 회사는 2026년 상반기에 주요 결과를 발표할 계획입니다.
이번 연구는 2b상 천식 연구의 사후 분석에서, 특히 기저 호산구 수치가 높은 환자에게서 잠재적 이점이 확인된 데 따른 것입니다. 현재 매년 약 130만 명의 환자가 COPD 악화로 응급실을 방문하며, 50%는 4주 내 치료 실패를 경험하고 있습니다.
Connect Biopharma (NASDAQ : CNTB) a lancé son étude de Phase 2 Seabreeze STAT COPD afin d’évaluer rademikibart comme traitement des exacerbations aiguës chez les patients atteints de BPCO. Cette étude, approuvée par la FDA, évaluera la sécurité et l’efficacité du médicament en complément des soins standards chez des patients présentant une BPCO et une inflammation de type 2.
L’essai prévoit d’inclure environ 160 participants à l’échelle mondiale, souffrant d’exacerbation aiguë de BPCO et ayant un taux d’éosinophiles ≥300 cellules/μL. Les participants recevront soit une dose unique de rademikibart, soit un placebo. Le critère principal sera le taux d’échec du traitement sur 28 jours après l’exacerbation aiguë. La société prévoit de publier les données principales au premier semestre 2026.
Cette initiative fait suite à une analyse post-hoc prometteuse de leur étude de Phase 2b sur l’asthme, montrant des bénéfices potentiels notamment chez les patients avec des taux d’éosinophiles basaux élevés. Actuellement, environ 1,3 million de patients se rendent chaque année aux urgences pour des poussées de BPCO, dont 50 % connaissent un échec du traitement dans les quatre semaines.
Connect Biopharma (NASDAQ: CNTB) hat seine Phase-2-Studie Seabreeze STAT COPD gestartet, um Rademikibart als Behandlung für akute Exazerbationen bei COPD-Patienten zu evaluieren. Die von der FDA genehmigte Studie wird die Sicherheit und Wirksamkeit des Medikaments als Zusatz zur Standardtherapie bei Patienten mit COPD und Typ-2-Entzündung untersuchen.
Die Studie wird weltweit etwa 160 Teilnehmer mit akuter COPD-Exazerbation und einer Eosinophilenzahl von ≥300 Zellen/μL einschließen. Die Teilnehmer erhalten entweder eine Einzeldosis Rademikibart oder ein Placebo. Der primäre Endpunkt ist die Messung der Therapieversagerate über 28 Tage nach der akuten Exazerbation. Das Unternehmen erwartet, die wichtigsten Daten im ersten Halbjahr 2026 zu berichten.
Diese Initiative folgt auf eine vielversprechende Post-hoc-Analyse ihrer Phase-2b-Asthmastudie, die insbesondere bei Patienten mit erhöhten Baseline-Eosinophilenzahlen potenzielle Vorteile zeigte. Derzeit suchen jährlich etwa 1,3 Millionen Patienten wegen COPD-Exazerbationen Notaufnahmen auf, wobei 50 % innerhalb von vier Wochen eine Therapieversagung erleben.
- FDA agreement obtained for Phase 2 study protocol
- Potential to be first biologic for rapid improvement of lung function in COPD exacerbations
- Promising post-hoc analysis data from Phase 2b Asthma study showing improvements in COPD-like patients
- Addresses large market with 1.3 million annual emergency department visits for COPD flare-ups
- Early-stage clinical trial (Phase 2) with results not expected until 1H 2026
- High treatment failure rate (50%) in current COPD exacerbation treatments indicates challenging therapeutic area
- Success depends on specific patient population with type 2 inflammation and elevated eosinophil counts
Insights
Connect Biopharma launches Phase 2 trial for novel COPD exacerbation treatment targeting significant unmet need in respiratory medicine.
Connect Biopharma's Phase 2 Seabreeze STAT COPD trial for rademikibart represents a significant development in acute COPD exacerbation management. This study will evaluate a single subcutaneous dose as an adjunct to standard care in approximately 160 patients with COPD exacerbations and elevated eosinophil counts (≥300 cells/μL), indicating type 2 inflammation.
The trial addresses a critical gap in COPD care. Currently, no approved biologics can rapidly improve lung function during acute exacerbations and prevent subsequent flare-ups. With 1.3 million annual emergency department visits for COPD exacerbations and a 50% treatment failure rate within four weeks, the unmet need is substantial.
The primary endpoint—treatment failure rate over 28 days—is clinically relevant and practical. Secondary endpoints comprehensively assess efficacy through exacerbation rates, respiratory symptom improvement, and lung function (FEV1) changes.
This trial follows encouraging post-hoc analysis from their asthma studies showing potential benefits in COPD-like patients, particularly those with elevated eosinophils. This suggests proper patient selection strategy using biomarkers. If successful, rademikibart could become the first biologic offering rapid intervention during acute exacerbations with potential long-term benefits, representing a paradigm shift from current treatment approaches which typically rely on systemic corticosteroids and antibiotics with limited long-term efficacy.
– Expect to report topline data from the Seabreeze STAT COPD study in 1H 2026 –
SAN DIEGO, May 14, 2025 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma, Connect or the Company), a clinical-stage biopharmaceutical company focused on transforming acute and chronic care of asthma and chronic obstructive pulmonary disease (COPD), today announced the initiation of its Phase 2 Seabreeze STAT COPD study (NCT06940154) following written agreement on the final study protocol from the U.S. Food and Drug Administration. The study will evaluate the safety and efficacy of rademikibart as an adjunct to standard of care for acute exacerbations in participants with COPD and type 2 inflammation.
“The initiation of our second Phase 2 study in patients with inflammatory lung disease highlights our commitment to swiftly advancing the development of rademikibart for asthma and COPD,” said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma. “In the current treatment landscape for patients experiencing an acute exacerbation with asthma or COPD, there are no approved biologics that can rapidly improve lung function and prevent further exacerbations over the short- and long-term. Based on our recently published Phase 2 data we believe rademikibart holds the potential to be the first biologic to deliver on this promise.”
The initiation of the Seabreeze STAT COPD study follows a post-hoc analysis in COPD-like patients from the Company’s previously completed global Phase 2b Asthma study. Data from the post-hoc analysis highlights the potential of rademikibart to improve outcomes for patients with COPD, with greatest improvements being observed in patients with elevated baseline eosinophil counts. Connect will present these data at the upcoming American Thoracic Society (ATS) 2025 International Conference, taking place May 18-21, 2025, in San Francisco.
“The arrival of biologics greatly advanced how we manage symptoms in COPD and asthma, but there remains a major unmet need for a fast, effective treatment immediately following acute exacerbations,” said Surya Bhatt, MD, Professor of Medicine in the Division of Pulmonary, Allergy and Critical Care Medicine at the University of Alabama at Birmingham School of Medicine. “Currently, 1.3 million patients visit the emergency department each year for a COPD flare-up and approximately
Seabreeze STAT COPD is a Phase 2, randomized, double-blind, placebo-controlled study evaluating rademikibart as an adjunct to standard of care for acute exacerbations in participants with COPD and type 2 inflammation. The study is expected to enroll approximately 160 participants globally who have an acute COPD exacerbation and type 2 inflammation, characterized by an eosinophil count of ≥300 cells/μL. Participants will receive either a single dose of rademikibart or placebo, administered subcutaneously. The primary endpoint is safety and efficacy of rademikibart as an adjunct to standard of care, as measured by the treatment failure rate over 28 days following an acute exacerbation. Secondary endpoints include rate and time to new moderate and severe COPD exacerbations, change-from-baseline in clinical respiratory symptoms of COPD, post- bronchodilator forced expiratory volume in one second (FEV1), and incidence of adverse events.
About Connect Biopharma and Rademikibart
Connect Biopharma is a clinical-stage biopharmaceutical company dedicated to transforming care for asthma and COPD. Headquartered in San Diego, California, the company is advancing rademikibart, a next-generation, potentially best-in-class anti-interleukin-4-receptor alpha (IL-4Rα) antibody. With an initial focus on acute exacerbations amongst the approximately 1 million asthma patients and 1.3 million COPD patients in the U.S. who visit an emergency room annually for an acute exacerbation—an area with significant unmet need—rademikibart has the potential to be initiated in the acute setting and then continued for chronic maintenance therapy in asthma and COPD. In a prior Phase 2 trial for chronic asthma, rademikibart demonstrated strong efficacy and safety data, with clinically meaningful reductions in exacerbations and rapid, statistically significant improvements in FEV1, observed within one week—and in most cases, within 24 hours via home spirometry.
For more information visit www.connectbiopharm.com.
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This press release discusses our product candidate, rademikibart, which is under clinical investigation and has not yet been approved for marketing by the U.S. Food and Drug Administration or by any other regulatory agency. No representation is made as to the safety or effectiveness of rademikibart for the uses for which it is being studied. The trademarks included herein are the property of the owners thereof and are used for reference purposes only.
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FAQ
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