Connect Biopharma Presents Late-Breaking Abstract at the American Thoracic Society 2024 International Conference on the Positive Rademikibart Data from its Global Phase 2b in Patients with Moderate-to-Severe Asthma
Connect Biopharma announced positive results from its global Phase 2b trial of rademikibart in patients with moderate-to-severe asthma. Presented at the American Thoracic Society 2024 Conference, the treatment significantly improved lung function and asthma control as early as Week 1, sustained through Week 24. An End-of-Phase 2 meeting with the FDA is scheduled for Q2 2024 to discuss Phase 3 plans. The study showed significant improvements in FEV1 at Week 12 and reduced annualized exacerbations by approximately 50%.
- Significant improvement in lung function observed as early as Week 1, sustained through Week 24.
- Significant improvement in patient-reported asthma control sustained through 24 weeks.
- Both doses of rademikibart showed significant improvement in pre-bronchodilator FEV1 at Week 12.
- Eosinophil levels ≥300 cells/µl showed further lung function improvement.
- Annualized exacerbations reduced by approximately 50%; prolonged time to exacerbation observed.
- End-of-Phase 2 meeting with the FDA scheduled for Q2 2024.
- The study was not powered to detect differences in exacerbations between treatment groups.
Insights
Rademikibart is showing promise as a treatment for moderate-to-severe asthma. The
Another notable finding is the improvement in patients with higher eosinophil levels (≥300 cells/µl), a subgroup often harder to treat. The reduction in asthma exacerbations, although the study wasn't powered to measure this, is also promising.
For retail investors, these results suggest rademikibart could fill a significant gap in asthma treatment. This is particularly relevant given the chronic and often severe nature of asthma.
In terms of impact, these findings could potentially lead to a strong Phase 3 trial and ultimate FDA approval, providing a new therapy option for asthma patients. Keep an eye on the upcoming FDA meeting as it will further clarify rademikibart’s path to market.
The positive results from the Phase 2b trial of rademikibart are a significant milestone for Connect Biopharma. Demonstrating early and sustained improvements in lung function and asthma control enhances the drug's potential market value. The reduction in exacerbations also adds a noteworthy dimension to its clinical benefits.
From a financial perspective, the End-of-Phase 2 (EoP2) meeting with the FDA in Q2 2024 is a critical event. A positive outcome could pave the way for a Phase 3 trial and subsequent market approval, significantly impacting the company's stock valuation and future revenue streams. Investors should consider the market potential of a successful Phase 3 trial, which could attract partnerships or acquisition interest from larger players.
The company's strategic focus on chronic inflammatory diseases aligns well with market demands, potentially positioning them as a key player in the asthma treatment market. However, investors should also be aware of the inherent risks associated with clinical trials, including potential setbacks in regulatory approval or unexpected adverse events.
- Rademikibart treatment significantly improved lung function at Week 12; improvements were observed as early as Week 1 and sustained through Week 24
- Significant improvement in patient-reported asthma control occurred early and was sustained through Week 24
- End of Phase 2 (EoP2) meeting is scheduled with the U.S. Food and Drug Administration (FDA) for Q2 2024
SAN DIEGO, CA and TAICANG, China, May 22, 2024 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma” or the “Company”), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, announced today that Edward Kerwin, M.D. presented a late-breaking poster presentation on the positive results from the rademikibart global Phase 2b trial in patients with moderate-to-severe asthma at the American Thoracic Society (ATS) 2024 International Conference, taking place May 17-22, 2024 in San Diego, CA.
“We are excited Dr. Kerwin shared the highly compelling results of our global Phase 2b study in asthma showing clinically meaningful and sustained improvement in lung function and asthma control with pulmonary experts at this year’s meeting,” commented Zheng Wei, Ph.D., Co-Founder and CEO of Connect Biopharma. “We are preparing for the End-of-Phase 2 meeting with the FDA for asthma in Q2 2024, and look forward to providing an update on next steps following the completion of this important meeting.”
The presentation, titled “Improved Lung Function and Asthma Control Observed with Rademikibart in Patients with Moderate-to-Severe Uncontrolled Asthma (CBP-201-WW002)”, highlighted results from the Phase 2b trial announced in December 2023 that showed that both doses of rademikibart led to significant improvements in pre-bronchodilator (BD) forced expiratory volume over one second (FEV1) at Week 12 with both rademikibart doses. Furthermore, the significant improvements seen compared to placebo with rademikibart started as early as Week 1 and were sustained through 24 weeks of treatment. A predefined exploratory analysis showed further improvement in lung function was achieved in patients with eosinophil levels of ≥300 cells/µl. A significant improvement in patient-reported asthma control occurred rapidly and was sustained through 24 weeks of treatment.
Additionally, although the study was not powered to detect differences in exacerbations between the treatment groups, strong trends for reductions in annualized exacerbations of approximately
The Company has scheduled an EoP2 meeting with the FDA to discuss rademikibart’s Phase 3 regulatory path in Q2 2024. A copy of the poster presentation will be made available on Connect Biopharma’s website under the “Our Science” section.
About Connect Biopharma Holdings Limited
Connect Biopharma is a global, clinical-stage biopharmaceutical company applying its expertise in T cell biology and deep knowledge of the drug discovery industry to develop innovative therapies to treat chronic inflammatory diseases with the goal of improving the lives of millions of those affected around the world. The Company is building a rich pipeline of proprietary small molecules and antibodies, using functional T cell assays, to screen and discover potent product candidates against validated immune targets. The Company’s lead product candidate, rademikibart (formerly known as CBP-201), is an antibody designed to target interleukin-4 receptor alpha (IL-4Rα) in development for the treatment of atopic dermatitis (AD) and asthma. The Company’s second product candidate, icanbelimod (formerly known as CBP-307), is a modulator of S1P1 T cell receptors and is in development for the treatment of ulcerative colitis (UC). For more information, please visit: https://www.connectbiopharm.com/
Forward-Looking Statements
Connect Biopharma cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “may”, “could”, “will”, “would”, “should”, “expect”, “plan”, “anticipate”, “believe”, “estimate”, “intend”, “predict”, “seek”, “contemplate”, “look forward”, “potential”, “continue” or “project” or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. These statements include the Company’s plans to advance the development of its product candidates, the timing of achieving any development, regulatory or commercial milestones or reporting data or whether such milestones or data will be achieved or generated, including whether any new drug application will be submitted or accepted and the timing thereof, and the potential of such product candidates, including to achieve any benefit, improvement, differentiation, trend or profile or any product approval or be effective, the Company’s ability to identify and enter into any strategic partnership, whether the Company’s Greater China partnership will meet expectations, and the sufficiency of the Company’s cash and investments to support planned operations. The inclusion of forward-looking statements should not be regarded as a representation by Connect Biopharma that any of its plans will be achieved. Actual data may differ materially from those set forth in this release due to the risks and uncertainties inherent in the Company’s business and other risks described in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on April 16, 2024, and its other reports. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Connect Biopharma undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included in Connect Biopharma’s filings with the SEC which are available from the SEC’s website (www.sec.gov) and on Connect Biopharma’s website (www.connectbiopharm.com) under the heading “Investors.” All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
INVESTOR CONTACT:
Tim McCarthy
LifeSci Advisors
FAQ
What were the significant findings of Connect Biopharma's Phase 2b trial for rademikibart in asthma patients?
When is Connect Biopharma's End-of-Phase 2 meeting with the FDA for rademikibart?
How did rademikibart perform in patients with eosinophil levels of ≥300 cells/µl?
Did the Phase 2b trial of rademikibart detect differences in exacerbations between treatment groups?
What improvements in lung function were observed with rademikibart at Week 12?
