Connect Biopharma Announces Positive Type C Meeting with the FDA for Rademikibart
Connect Biopharma (NASDAQ: CNTB) has received positive feedback from the FDA regarding its Type C meeting for rademikibart, advancing plans for two parallel Phase 2 trials in Q2 2025. The trials will evaluate the drug's effectiveness in patients with moderate-to-severe asthma or COPD experiencing acute exacerbations.
Each trial will enroll approximately 160 patients with eosinophils ≥300 cells/µL, testing a single 600 mg subcutaneous dose of rademikibart over 28 days following an acute exacerbation. Previous Phase 2 studies showed the drug was well-tolerated and improved pulmonary function within 24 hours.
The company expects to report trial data in H1 2026 and maintains a cash runway into 2027. Currently, about 45% of patients receiving standard care experience treatment failure within 28 days post-exacerbation, highlighting a significant unmet medical need.
Connect Biopharma (NASDAQ: CNTB) ha ricevuto un riscontro positivo dalla FDA riguardo al suo incontro di tipo C per rademikibart, facendo avanzare i piani per due studi di Fase 2 paralleli nel secondo trimestre del 2025. Gli studi valuteranno l'efficacia del farmaco in pazienti con asma da moderata a grave o BPCO che stanno vivendo esacerbazioni acute.
Ogni studio arruolerà circa 160 pazienti con eosinofili ≥300 cellule/µL, testando una singola dose sottocutanea di 600 mg di rademikibart per 28 giorni dopo un'esacerbazione acuta. Studi precedenti di Fase 2 hanno dimostrato che il farmaco era ben tollerato e migliorava la funzione polmonare entro 24 ore.
L'azienda prevede di riportare i dati degli studi nel primo semestre del 2026 e mantiene una liquidità sufficiente fino al 2027. Attualmente, circa il 45% dei pazienti che ricevono cure standard sperimentano un fallimento del trattamento entro 28 giorni dopo l'esacerbazione, evidenziando un'importante esigenza medica insoddisfatta.
Connect Biopharma (NASDAQ: CNTB) ha recibido comentarios positivos de la FDA sobre su reunión de tipo C para rademikibart, avanzando en los planes para dos ensayos paralelos de Fase 2 en el segundo trimestre de 2025. Los ensayos evaluarán la eficacia del fármaco en pacientes con asma de moderada a grave o EPOC que experimentan exacerbaciones agudas.
Cada ensayo inscribirá aproximadamente a 160 pacientes con eosinófilos ≥300 células/µL, probando una única dosis subcutánea de 600 mg de rademikibart durante 28 días tras una exacerbación aguda. Estudios previos de Fase 2 mostraron que el fármaco fue bien tolerado y mejoró la función pulmonar en 24 horas.
La compañía espera informar sobre los datos del ensayo en la primera mitad de 2026 y mantiene una liquidez suficiente hasta 2027. Actualmente, alrededor del 45% de los pacientes que reciben atención estándar experimentan fracaso del tratamiento dentro de los 28 días posteriores a la exacerbación, lo que destaca una necesidad médica significativa no satisfecha.
Connect Biopharma (NASDAQ: CNTB)는 rademikibart에 대한 타입 C 회의에서 FDA로부터 긍정적인 피드백을 받았으며, 2025년 2분기에 두 개의 병행 제2상 시험 계획을 진행하고 있습니다. 이 시험들은 급성 악화를 경험하는 중등도에서 중증 천식 또는 COPD 환자에서 약물의 효과를 평가할 것입니다.
각 시험은 약 160명의 eosinophils ≥300 cells/µL 환자를 등록하며, 급성 악화 후 28일 동안 rademikibart의 단일 600 mg 피하 주사를 테스트합니다. 이전의 제2상 연구에서는 이 약물이 잘 견디며 24시간 이내에 폐 기능을 개선한 것으로 나타났습니다.
회사는 2026년 상반기에 시험 데이터를 보고할 예정이며, 2027년까지 자금을 유지할 수 있습니다. 현재 표준 치료를 받는 환자의 약 45%가 악화 후 28일 이내에 치료 실패를 경험하고 있어, 이는 중요한 의료적 필요가 충족되지 않고 있음을 강조합니다.
Connect Biopharma (NASDAQ: CNTB) a reçu des retours positifs de la FDA concernant sa réunion de type C pour rademikibart, faisant avancer les plans pour deux essais de phase 2 parallèles au deuxième trimestre 2025. Les essais évalueront l'efficacité du médicament chez des patients souffrant d'asthme modéré à sévère ou de BPCO connaissant des exacerbations aiguës.
Chaque essai recrutera environ 160 patients avec des éosinophiles ≥300 cellules/µL, testant une dose unique sous-cutanée de 600 mg de rademikibart sur 28 jours après une exacerbation aiguë. Des études précédentes de phase 2 ont montré que le médicament était bien toléré et améliorait la fonction pulmonaire dans les 24 heures.
L'entreprise prévoit de communiquer les données des essais au premier semestre 2026 et maintient une trésorerie suffisante jusqu'en 2027. Actuellement, environ 45 % des patients recevant des soins standards connaissent un échec du traitement dans les 28 jours suivant l'exacerbation, soulignant un besoin médical non satisfait significatif.
Connect Biopharma (NASDAQ: CNTB) hat positives Feedback von der FDA zu seinem Typ-C-Meeting für rademikibart erhalten und plant zwei parallele Phase-2-Studien im zweiten Quartal 2025. Die Studien werden die Wirksamkeit des Medikaments bei Patienten mit mäßigem bis schwerem Asthma oder COPD, die akute Exazerbationen erleben, bewerten.
Jede Studie wird etwa 160 Patienten mit Eosinophilen ≥300 Zellen/µL einschließen und eine einmalige subkutane Dosis von 600 mg rademikibart über 28 Tage nach einer akuten Exazerbation testen. Frühere Phase-2-Studien zeigten, dass das Medikament gut verträglich war und die Lungenfunktion innerhalb von 24 Stunden verbesserte.
Das Unternehmen erwartet, die Studiendaten im ersten Halbjahr 2026 zu berichten und hat eine ausreichende finanzielle Basis bis 2027. Derzeit erfahren etwa 45% der Patienten, die eine Standardbehandlung erhalten, innerhalb von 28 Tagen nach einer Exazerbation einen Behandlungsversagen, was auf einen erheblichen ungedeckten medizinischen Bedarf hinweist.
- FDA alignment obtained for Phase 2 trials in both asthma and COPD
- Previous Phase 2 study showed rapid improvement in pulmonary function within 24 hours
- Cash runway extends into 2027
- Addresses unmet medical need with no current approved biologic therapies for acute exacerbations
- Phase 2 trials won't start until Q2 2025
- Results won't be available until first half of 2026
- to patients with specific eosinophil levels (≥300 cells/µL)
Insights
Connect Biopharma's positive Type C meeting with the FDA represents a significant development for their lead candidate rademikibart. The regulatory alignment on parallel Phase 2 trials targeting both asthma and COPD acute exacerbations addresses a critically underserved therapeutic area where no biologics have been approved.
The company's strategy focuses on a specific clinical niche with substantial unmet need – the vulnerable 28-day window following an acute exacerbation, during which approximately
Previous Phase 2 data showed rademikibart's 600mg subcutaneous loading dose produced rapid pulmonary function improvements in under 24 hours – precisely the quick-action profile needed for acute intervention. The well-defined trial design (160 patients per trial, eosinophils ≥300 cells/µL) demonstrates rigorous patient selection to maximize potential efficacy signals.
With both trials initiating in Q2 2025 and data expected in H1 2026, Connect has established clear developmental milestones. Their stated cash runway extending into 2027 provides sufficient financial cushion to reach these critical readouts without immediate dilution concerns. For a company with a modest
The FDA's alignment during Connect Biopharma's Type C meeting marks an important regulatory milestone for rademikibart's development program. Type C meetings typically address specific questions outside the standard milestone meetings, suggesting Connect strategically engaged the agency to refine their approach before proceeding.
Particularly noteworthy is the FDA's acknowledgment of the unmet need for reducing recurrent exacerbations post-acute episodes – explicit regulatory recognition that can streamline subsequent development. This positions Connect to potentially pioneer the first biologic therapy specifically studied and approved for this indication.
The parallel trial approach in both asthma and COPD is an efficient regulatory strategy that could accelerate the overall development timeline if successful. Each indication represents a distinct potential approval pathway and market opportunity, effectively doubling the program's shots on goal.
Connect's upcoming Phase 2 trials employ a straightforward single-dose design that, if successful, could lead to a relatively uncomplicated Phase 3 program. The specific biomarker-driven enrollment criteria (eosinophils ≥300 cells/µL) demonstrates a precision medicine approach that regulatory agencies increasingly favor, as it identifies patients most likely to benefit.
While positive Type C feedback doesn't guarantee ultimate approval, it significantly de-risks Connect's near-term clinical development strategy and provides a clearer pathway toward potential registration trials.
– FDA aligned on plan to initiate parallel Phase 2 trials of rademikibart in patients with moderate-to-severe asthma or COPD experiencing an acute exacerbation –
– Expect to initiate both trials in Q2 2025 –
SAN DIEGO, April 01, 2025 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect or Connect Biopharma), a clinical-stage biopharmaceutical company focused on transforming acute and chronic care of asthma and chronic obstructive pulmonary disease (COPD), today announced positive feedback from its Type C meeting with the U.S. Food and Drug Administration (FDA), Division of Pulmonology, Allergy, and Critical Care, in the Office of Immunology and Inflammation.
“We are pleased to have the FDA’s alignment on our two parallel Phase 2 trials evaluating rademikibart in patients experiencing an acute exacerbation of asthma or COPD, an area where no biologic therapies have been approved or systematically studied,” said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma. “During our Type C meeting, the FDA acknowledged the unmet need for reducing recurrent exacerbations during the vulnerable 28-day period following an acute exacerbation of asthma or COPD. In our previously completed Phase 2 study for the maintenance treatment of asthma, a 600 mg subcutaneous (SC) loading dose of rademikibart was well-tolerated and delivered robust improvement in pulmonary function in less than 24 hours. This promising data suggests that rademikibart could provide meaningful and rapid benefit to the millions of patients who experience exacerbations of asthma or COPD and are seen in emergency departments or are hospitalized each year.”
Based on the advice from the FDA at the meeting, Connect plans to begin enrolling patients in these trials during the second quarter of this year.
The two parallel Phase 2 randomized, double-blind, placebo-controlled trials are expected to each enroll approximately 160 patients and include patients with uncontrolled, moderate-to-severe asthma or COPD with eosinophils ≥300 cells/µL who are experiencing an acute exacerbation. The trials are designed to evaluate the benefits of a single 600 mg SC dose of rademikibart in patients over 28 days following an acute exacerbation. Based on the results of a recently published trial of a similar design, approximately
“Asthma and COPD patients face a heightened risk of further exacerbations within the first 28 days following an initial episode. While biologics have demonstrated significant success in maintenance therapy, none have been approved to address airway symptoms immediately after an acute exacerbation,” said Mario Castro, MD, MPH, Professor and Chief of Pulmonary, Critical Care and Sleep Medicine at the University of Kansas School of Medicine. “The pulmonology community is encouraged by the plan to evaluate the potential benefits of a single 600 mg SC dose of rademikibart following an acute exacerbation in these Phase 2 trials in patients with asthma and COPD.”
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—an area with significant unmet need—rademikibart has the potential to also drive chronic utilization in asthma and COPD amongst the approximately 1 million asthma patients and 1.3 million COPD patients in the U.S. who experience acute exacerbations annually. In a Phase 2 trial for 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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- Ramakrishnan S, et.al. Treating eosinophilic exacerbations of asthma and COPD with benralizumab (ABRA): a double-blind, double-dummy, active placebo-controlled randomised trial. Lancet 2025; 13(1): 59-68.
FAQ
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