Connect Biopharma Announces Positive Preliminary Topline Data from its Global Phase 2 Study of Rademikibart as an Add-on Treatment for Acute Exacerbations in Adult and Adolescent Participants with Asthma and Type 2 Inflammation
Phase 2 results for rademikibart in acute asthma exacerbations support advancing toward FDA-aligned Phase 3 development and broader acute care use.
Rhea-AI Summary
Connect Biopharma (CNTB) reported positive preliminary topline Phase 2 data for rademikibart as add-on treatment for acute asthma exacerbations with type 2 inflammation.
The randomized, double-blind, placebo-controlled Seabreeze STAT Asthma study enrolled 160 participants, dosed 600 mg subcutaneously plus standard of care versus placebo. Rademikibart achieved a statistically significant improvement in post-bronchodilator FEV1 at Day 7, with a mean increase of 250 mL versus 120 mL on placebo (130 mL difference; p=0.023). Treatment failure over 28 days was reduced by approximately 66% versus placebo (p=0.153), and emergency department or unscheduled medical visits for worsening asthma were reduced by 50%. Rademikibart was well tolerated, with safety comparable to placebo and fewer serious adverse events. Phase 2 COPD data are expected later this month, after which the company plans FDA discussions on a Phase 3 program.
Positive
- FEV1 improvement at Day 7: 250 mL with rademikibart vs 120 mL placebo (p=0.023)
- Treatment failures reduced by approximately 66% over 28 days vs placebo
- Emergency/unscheduled visits for worsening asthma reduced by 50% vs placebo
- Safety profile comparable to placebo, with 1 SAE on rademikibart vs 3 on placebo
- Phase 3 path: company plans FDA discussions after Phase 2 COPD readout later this month
Negative
- Primary endpoint treatment failure reduction (66%) did not reach statistical significance (p=0.153)
- Lower-than-projected event rate for treatment failure may complicate interpretation and future trial design
Details
Market reaction after Phase 2 clinical data: CNTB -38.46%
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Key Figures
- Treatment failure reduction
- 66%
- 28 days versus placebo; p=0.153
- Day 7 FEV1
- 250 mL vs. 120 mL
- Post-bronchodilator change from baseline versus placebo
- FEV1 treatment difference
- 130 mL
- Greater improvement than placebo at Day 7; p=0.023
- Study enrollment
- 160 patients
- Randomized 1:1 in the Phase 2 asthma study
- Rademikibart dose
- 600 mg
- Subcutaneous dose; n=79 versus placebo n=81
- Treatment failure p-value
- p=0.153
- 28-day treatment failure endpoint
- Serious adverse events
- 1 vs. 3 SAEs
- Rademikibart arm versus placebo arm
Previous Clinical trial Reports
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Enrollment completed in the same Seabreeze STAT asthma study
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Interim review found no safety concerns and enrollment continued
-
Rademikibart produced positive atopic dermatitis efficacy results
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
fev1 medical
post-bronchodilator medical
anti-interleukin-4-receptor alpha medical
sae medical
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– Rademikibart meaningfully reduced the rate of treatment failure at 28 days by
–Rademikibart produced a rapid, statistically significant improvement in lung function at Day 7 compared to placebo –
– Rademikibart was well tolerated in asthma patients experiencing an acute exacerbation with a low incidence of adverse events–
– Data from Seabreeze STAT COPD study of rademikibart will be available later this month after which Connect plans to engage with the U.S. Food and Drug Administration (FDA) to gain alignment on a Phase 3 program –
– Company to host a conference call to discuss the data today, September 15 at 8:00 a.m. ET –
SAN DIEGO, Sept. 15, 2026 (GLOBE NEWSWIRE) -- 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
“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. “
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.
Company-Hosted Conference Call and Webcast
Connect will host a conference call and webcast today, September 15, 2026, at 8:00 a.m. ET. To access the conference call, please pre-register through here to receive dial-in information and a personal PIN to access the live call. Participants may access the live webcast here or from the Investors section of the Connect website at investors.connectbiopharma.com. An archive of the webcast and presentation will be available for approximately 90 days after the event.
About the Seabreeze STAT Asthma Study
Seabreeze STAT Asthma is a Phase 2, randomized, double-blind, placebo-controlled study evaluating 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 has enrolled 160 participants globally with an eosinophil count of ≥300 cells/μL who have experienced an acute asthma exacerbation. Participants received either a single dose of rademikibart or placebo, administered subcutaneously. The primary endpoint is treatment failure rate over 28 days following an acute exacerbation. The key secondary endpoint is post-bronchodilator (post-BD) forced expiratory volume in one second (FEV1) at Week 1. Other secondary endpoints include rate and time to new asthma exacerbations, change-from-baseline in asthma symptom score and nocturnal awakenings, post-BD FEV1 at other timepoints, and incidence of adverse events for 8 weeks after dosing. For more information, please visit clinicaltrials.gov (identifier NCT06940141).
About Rademikibart
Rademikibart is a fully human monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Rα), a common subunit of interleukin-4 receptor (IL-4) and interleukin-13 receptor (IL-13). We believe that by binding with IL-4Rα, rademikibart can block the functions of IL-4 and IL-13 effectively, thereby blocking the T helper 2 (Th2) inflammatory pathway to achieving the goal of treating Th2 related inflammatory diseases such as atopic dermatitis, asthma and COPD.
About Connect Biopharma
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 antibody designed to target IL-4Rα. The Company is currently conducting global clinical studies of rademikibart for the treatment of acute exacerbations of asthma and COPD, areas with significant unmet need. Connect has granted an exclusive license to Simcere Pharmaceutical Co., Ltd., for rademikibart in Greater China. Under the exclusive license and collaboration agreement, Connect is eligible to receive remaining milestone payments up to an aggregate amount of approximately
For more information visit www.connectbiopharma.com.
Forward-Looking Statements
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Words such as “aim,” “anticipate,” “believe,” “commitments,” “continue,” “could,” “design,” “estimate,” “expect,” “feel,” “goal,” “intend,” “may,” “might,” “objective,” “optimistic,” “plan,” “potential,” “predict,” “promising,” “seek,” “should,” “target,” “will,” “would,” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. The inclusion of forward-looking statements should not be regarded as a representation by Connect Biopharma that any of its expectations, projections or plans will be achieved. Actual results or outcomes, or the timing of such results or outcomes, may differ materially from those expressed or implied in our forward-looking statements due to the risks and uncertainties described above. These forward-looking statements should not be taken as forecasts or promises nor should they be taken as implying any indication, assurance or guarantee that the assumptions on which such forward-looking statements have been made are correct or exhaustive or, in the case of the assumptions, fully stated herein. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You are cautioned not to place undue reliance on the scientific data presented or these forward-looking statements, which speak only as of the date hereof. Except as required by law, Connect Biopharma undertakes no obligation to publicly update any forward-looking statements, whether because of new information, future events or otherwise.
This press release discusses our product candidate, rademikibart, which is under clinical investigation and has not yet been approved for marketing by the FDA, the NMPA, 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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