Connect Biopharma to present data on rademikibart for asthma and COPD at ATS 2025, initiating Phase 2 trials in 2025.
Quiver AI Summary
Connect Biopharma Holdings Limited announced its plans to present four posters at the American Thoracic Society 2025 International Conference, showcasing data that supports the development of rademikibart, an investigational treatment for patients with moderate-to-severe asthma and COPD experiencing acute exacerbations. The company is advancing its clinical development plan for rademikibart, with expectations to initiate parallel Phase 2 trials in the second quarter of 2025. The posters will feature findings on rademikibart's efficacy, blood eosinophil counts, and improvements in lung function. The presentations underscore the potential of rademikibart as a best-in-class anti-IL-4Rα antibody aimed at addressing significant unmet medical needs in this patient population. More information will be available on Connect's website following the conference.
Potential Positives
- Data presented at the American Thoracic Society 2025 International Conference supports the potential efficacy of rademikibart for treating moderate-to-severe asthma and COPD, indicating significant progress in the development of this therapy.
- The company is advancing a rapid clinical development plan for rademikibart, with parallel Phase 2 trials expected to initiate in 2Q25, demonstrating a commitment to timely product development.
- Positive Phase 2 trial results for rademikibart have shown strong efficacy and safety, including meaningful reductions in exacerbations and rapid improvements in lung function, which may attract interest from healthcare providers and investors.
Potential Negatives
- Company has not yet obtained regulatory approval for rademikibart, presenting a risk to its future commercialization efforts.
- Press release heavily relies on forward-looking statements, underscoring uncertainties that could materially affect the company's projections and expectations.
- Emphasis on clinical trials indicates that while results may be promising, early-stage data may not predict success in later stages or regulatory approval, highlighting inherent risks in drug development.
FAQ
What is rademikibart's purpose in asthma and COPD treatment?
Rademikibart aims to improve care for patients with moderate-to-severe asthma and COPD, especially during acute exacerbations.
When will the Phase 2 trials for rademikibart start?
The parallel Phase 2 trials for rademikibart are expected to initiate in the second quarter of 2025.
Where will Connect Biopharma present research on rademikibart?
Connect Biopharma will showcase research at the American Thoracic Society International Conference in San Francisco, from May 18-21, 2025.
What results have been observed from rademikibart trials?
The trials indicate rademikibart has strong efficacy and safety, with rapid improvements in lung function reported within 24 hours.
How can I find more information about Connect Biopharma?
Additional information about Connect Biopharma and rademikibart can be found on their official website at www.connectbiopharm.com.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
– Data to be presented supports development of rademikibart for patients with moderate-to-severe asthma or COPD experiencing an acute exacerbation –
– Advancing rapid clinical development plan for rademikibart; expect to initiate parallel Phase 2 trials in 2Q25 –
SAN DIEGO, April 24, 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 Company will present four posters at the American Thoracic Society (ATS) 2025 International Conference, taking place May 18-21, 2025, in San Francisco.
The following abstracts are posted on ATS 2025’s online itinerary planner for registered users:
Title:
Efficacy of Rademikibart in COPD-like Patients: Sub-analyses From the Phase 2b Trial in Patients with Moderate-to-Severe Asthma
Presenter:
Raúl Collazo, Ph.D.
Session
A32:
It’s Not Easy Being Wheezy: Asthma and COPD Clinical Studies
Format:
Thematic Poster Session
Poster #:
P1386
Date and Time:
Sunday, May 18, 2025, from 11:30 a.m. – 1:15 p.m. PT
Title:
Effect of Rademikibart on Blood Eosinophil Counts in Patients with Asthma: Is There an IL-4Rα Class Effect?
Presenter:
Michael Wechsler, M.D.
Session
A33:
Biomarker Window into Lung Disease
Format:
Thematic Poster Session
Poster #:
P1515
Date and Time:
Sunday, May 18, 2025, from 11:30 a.m. – 1:15 p.m. PT
Title:
Optimized Second-generation IL-4Rα Inhibition: Structural and Molecular Dynamics Properties of Rademikibart Fab-IL-4Rα Complex
Presenter:
Raúl Collazo, Ph.D.
Session A34:
Winning the Biologic Battle in Asthma and COPD
Format:
Thematic Poster Session
Poster #:
P1439
Date and Time:
Sunday, May 18, 2025, from 11:30 a.m. – 1:15 p.m. PT
Title:
Rapid Improvement in Lung Function Observed with Rademikibart in Patients with Moderate-to-Severe Uncontrolled Asthma
Presenter:
Michael Wechsler, M.D.
Session B101:
Fixing Barriers: Unlocking Treatment Modalities in Inflammatory Lung Diseases
Format:
Poster Discussion Session
Poster #:
1020
Date and Time:
Monday, May 19, 2025: Viewing: 2:15 p.m. – 3:00 p.m. PT | Discussion: 3:15 p.m. – 4:15 p.m. PT
Following the presentations, each poster will be 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 (FEV
1
), 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,” “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 these forward-looking statements, which speak only as of the date of this presentation. 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 product candidates that are under clinical study, and which have 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 these product candidates for the use for which such product candidates are 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
Ignacio.guerrero-ros@russopartnersllc.com
David.schull@russopartnersllc.com
(858) 717-2310 or (646) 942-5604
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