Connect Biopharma Presents Data Supporting Rademikibart at the European Academy of Allergy and Clinical Immunology (EAACI) 2025 Annual Congress

Rhea-AI Summary

Connect Biopharma presented clinical data for rademikibart, their investigational anti-IL-4Rα antibody, at EAACI 2025. The Phase 2b trial results showed significant improvements in lung function and asthma control for patients with eosinophilic-driven type 2 asthma. Rademikibart demonstrated rapid improvement in prebronchodilator FEV1 from Week 1, sustained through 24 weeks. The drug achieved notable reductions in annualized asthma exacerbation rates: 63% in patients with elevated baseline eosinophils, 69% in elevated FeNO patients, and 74% in those with both markers elevated. The company expects to report topline data from ongoing Phase 2 acute exacerbation studies in asthma and COPD in the first half of 2026.

Positive

• Significant and rapid improvement in lung function (FEV1) from Week 1, sustained through 24 weeks
• Strong reduction in annualized asthma exacerbation rates up to 74% in specific patient groups
• Lower reports of high post-baseline eosinophil counts compared to published dupilumab data
• Potential best-in-class efficacy for asthma treatment

Negative

• None.

Insights

Biotech Clinical Development Expert

Connect Biopharma's rademikibart shows promising Phase 2b results in asthma, significantly improving lung function and reducing exacerbations in key patient subgroups.

The data presented at EAACI 2025 demonstrates potentially compelling efficacy for Connect Biopharma's anti-IL-4Rα antibody rademikibart in treating eosinophilic-driven type 2 asthma. The post-hoc analyses from their Phase 2b trial revealed rapid improvement in lung function starting at week 1 that was sustained through 24 weeks, particularly in patients with elevated baseline eosinophil counts.

Most notably, the drug achieved substantial reductions in annualized asthma exacerbation rates (AAER) across important patient subgroups: 63% reduction in patients with elevated baseline eosinophils, 69% reduction in those with elevated FeNO (a marker of airway inflammation), and an impressive 74% reduction in patients with both elevated markers. These are clinically meaningful reductions that compare favorably to existing therapies.

The data also indicates rademikibart treatment resulted in fewer patients experiencing high post-baseline eosinophil counts compared to published dupilumab data. This suggests a potentially differentiated safety profile from existing IL-4Rα inhibitors, which is critical in this competitive therapeutic space.

This data strengthens the rationale for Connect's ongoing Phase 2 Seabreeze STAT studies in both asthma and COPD acute exacerbations, with topline results expected in 1H26. If these trials confirm the efficacy signals seen in the Phase 2b data, rademikibart could position itself as a potentially best-in-class therapy in the growing biologics market for respiratory diseases. The focus on patients with type 2 inflammation biomarkers also indicates a precision medicine approach that could optimize treatment outcomes in well-defined patient populations.

– Rademikibart significantly improved lung function and asthma control in patients with eosinophilic-driven type 2 asthma –

– Rademikibart reduced annualized exacerbations in patients with eosinophilic-driven type 2 asthma –

– Data supports ongoing Phase 2 acute exacerbation studies in asthma and COPD; expect to report topline data from both studies in 1H26 –

SAN DIEGO, June 13, 2025 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma” 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 presentation of clinical data supporting rademikibart, the Company’s investigational, next-generation, potentially best-in-class anti-interleukin-4-receptor alpha (IL-4Rα) antibody, at the European Academy of Allergy and Clinical Immunology (EAACI) 2025 Annual Congress, taking place June 13-16, 2025, in Glasgow, United Kingdom and virtually.

“The data being presented today at EAACI continues to demonstrate the potential of rademikibart to deliver best-in-class efficacy for asthma patients,” said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma. “Building on the previously reported data from our Phase 2b asthma study, these analyses highlight rademikibart’s capability to not only rapidly deliver improvements in lung function, but also significantly reduce annualized asthma exacerbation rates, particularly in those with high eosinophil and fractional exhaled nitric oxide or FeNO counts, key markers of type 2 inflammation. We believe these findings continue to bolster support for our rapid Phase 2 clinical development plan and we look forward to reporting topline data from our parallel Seabreeze STAT studies in the first half of 2026.”

Abstract Title: Improvement in Lung Function with Rademikibart in Eosinophilic Driven, Type 2 Asthma
Abstract Number: 001678
Presenter: Rekha Chaudhuri, M.D.
Session Title: Clinical Trials on Airways Diseases
Date and Time: Friday, June 13^th from 3:00 p.m. – 4:30 p.m. BST

• Results from the Company’s Phase 2b trial of rademikibart in moderate-to-severe asthma were evaluated in a post-hoc analysis to assess rademikibart’s ability to improve lung function in subgroups of patients with Type 2 inflammation-driven asthma, as indicated by elevated baseline eosinophil counts of ≥150 or ≥300 cells/µL.
• Rademikibart rapidly improved prebronchodilator forced expiratory volume in one second (FEV₁) at the first in-clinic assessment at Week 1, which was sustained through 24 weeks of treatment, with greater improvement demonstrated in the elevated baseline eosinophil subgroups than in the overall population.
• In addition to objective lung function, rapid and sustained improvements in patient reported asthma control in the rademikibart treatment groups were also noted, evidenced by increased change from baseline in Asthma Control Questionnaire (ACQ-6) scores in the elevated baseline eosinophil subgroups as compared to placebo.
• Rademikibart treatment groups were associated with substantially lower reports of patients experiencing high post-baseline eosinophil counts compared to published dupilumab data.
• These results demonstrate that rademikibart has the potential to improve lung function in patients with Type 2 inflammation-driven asthma.
  
  

Abstract Title: Reduction in Annualized Exacerbations with Rademikibart in Eosinophilic Driven, Type 2 Asthma
Abstract Number: 001671
Presenter: Rekha Chaudhuri, M.D.
Session Title: Clinical Trials on Airways Diseases
Date and Time: Friday, June 13^th from 3:00 p.m. – 4:30 p.m. BST

• Results from the Company’s Phase 2b trial of rademikibart in moderate-to-severe asthma were investigated in a post-hoc analysis to determine the annualized asthma exacerbation rate (AAER) in patients with Type 2 inflammation-driven asthma, as indicated by elevated baseline eosinophil counts of ≥150 or ≥300 cells/µL. The analysis also evaluated changes in annualized asthma exacerbation rate based on elevated exhaled nitric oxide (FeNO ≥25 ppb), an additional, independent marker of Type 2 inflammation.
• Rademikibart also achieved clinically meaningful reductions in AAER in subgroups with markers of Type 2 inflammation: 63% in patients with elevated baseline eosinophils, 69% in patients with elevated FeNO, and 74% in patients with elevated baseline eosinophils and elevated FeNO.
• These results highlight rademikibart’s potential to reduce asthma exacerbations, particularly in patients with elevated markers of Type 2 inflammation.
  
  

The presentations are available on Connect’s website under the presentations and publications section.

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 forced expiratory volume in one second (FEV₁), observed within one week—and in most cases, within 24 hours via home spirometry.

For more information visit www.connectbiopharm.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended (the “Act”). Forward-looking statements are statements that are not of historical fact and include, without limitation, statements regarding future events, our future financial condition, results of operations, business strategy and plans, prospective products (as well as their potential to achieve a differentiated, competitive, or favorable benefit or profile or trend, including on safety, tolerability, improvement, maintenance, clinical response, dosing, efficacy and/or convenience), planned or expected product approval applications or approvals, anticipated milestones, expected data readouts and enrollments, research and development plans and costs, potential future partnerships, expectations about existing partnerships, timing and likelihood of success, objectives of management for future operations, future results of anticipated product development efforts, and adequacy of existing cash and potential partnership funding to fund operations and capital expenditure requirements, as well as statements regarding industry trends. These statements are based on management’s current expectations of future events only as of the date of this press release and are inherently subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control, including, among other things: the ability of our clinical trials to demonstrate safety and efficacy of our product candidates and other positive results; whether we will need expanded or additional trials in order to obtain regulatory approval for our product candidates; our ability to obtain and maintain regulatory approval of our product candidates; existing regulations and regulatory developments in the U.S., the PRC, Europe and other jurisdictions; the ability of our current cash and investments position to support planned operations; our plans and ability to obtain, maintain, protect and enforce our intellectual property rights and our proprietary technologies, including extensions of existing patent terms where available; our continued reliance on third parties to conduct additional clinical trials of our product candidates, and for the manufacture of our product candidates for preclinical studies and clinical trials; and the degree of market acceptance of our product candidates, if approved, by physicians, patients, healthcare payors and others in the medical community.

Words such as “aim,” “anticipate,” “believe,” “could,” “expect,” “feel,” “goal,” “intend,” “look forward to,” “may,” “optimistic,” “plan,” “potential,” “promising,” “will,” 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 may differ materially due to the risks and uncertainties inherent in our business and other risks described in our filings with the U.S. Securities and Exchange Commission (the “SEC”). Further information regarding these and other risks is included under the heading “Risk Factors” in our annual and periodic reports filed with the SEC. 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 in this presentation. 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 any forward-looking statements, which speak only as of the date of such presentation(s) or such statements. 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. Connect Biopharma claims the protection of the safe harbor for forward-looking statements contained in the Act for all forward-looking statements.

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.

Investor Relations Contact:

Alex Lobo
Precision AQ
Alex.Lobo@precisionaq.com
(212) 698-8802

Media Contact:

Ignacio Guerrero-Ros, Ph.D., or David Schull
Russo Partners, LLC
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(858) 717-2310 or (646) 942-5604

FAQ

What were the key findings from Connect Biopharma's rademikibart Phase 2b trial for CNTB stock?

The trial showed significant improvements in lung function from Week 1, sustained through 24 weeks, and reduced annualized asthma exacerbation rates by up to 74% in patients with elevated inflammatory markers.

When will Connect Biopharma (CNTB) report topline data for their Phase 2 studies?

Connect Biopharma expects to report topline data from their Seabreeze STAT studies in asthma and COPD in the first half of 2026.

How does rademikibart compare to dupilumab in asthma treatment?

According to the data presented, rademikibart treatment groups showed substantially lower reports of high post-baseline eosinophil counts compared to published dupilumab data.

What patient populations showed the best response to rademikibart in the CNTB trials?

Patients with elevated markers of Type 2 inflammation showed the best response, particularly those with both elevated baseline eosinophils and elevated FeNO, achieving a 74% reduction in exacerbation rates.

What is the mechanism of action of Connect Biopharma's rademikibart?

Rademikibart is an investigational next-generation anti-interleukin-4-receptor alpha (IL-4Rα) antibody designed to treat type 2 inflammation in asthma and COPD.