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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 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在美國胸科學會2024年國際會議上發表最新摘要,介紹其全球2b期中度至重度哮喘患者的Rademikibart陽性數據
康乃德生物 ·  05/22 12:00
  • 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
  • Rademikibart 治療在第 12 周顯著改善了肺功能;早在第 1 周就觀察到了改善,一直持續到第 24 周
  • 患者報告的哮喘控制出現了早期的顯著改善,一直持續到第24周
  • 計劃於2024年第二季度與美國食品藥品監督管理局(FDA)舉行第二階段結束(EoP2)會議

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.

加利福尼亞州聖地亞哥和中國太倉,2024年5月22日(GLOBE NEWSWIRE)——Connect Biopharma Holdings Limited(納斯達克股票代碼:CNTB)(“Connect Biopharma” 或 “公司”)是一家全球臨床階段的生物製藥公司,致力於通過開發源自T細胞研究的療法來改善慢性炎症性疾病患者的生活,今天宣佈,醫學博士愛德華·克文提出了一份報告最新海報展示了針對中度至重度哮喘患者的rademikibart全球2b期試驗的積極結果美國胸科學會(ATS)2024年國際會議將於2024年5月17日至22日在加利福尼亞州聖地亞哥舉行。

"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."

Connect Biopharma聯合創始人兼首席執行官鄭偉博士評論說:“我們很高興Kerwin博士在今年的會議上與肺部專家分享了我們全球2b期哮喘研究的令人信服的結果,這些結果顯示肺功能和哮喘控制具有臨床意義且持續的改善。”“我們正在爲2024年第二季度與美國食品藥品管理局就哮喘問題舉行的第二階段結束會議做準備,並期待在這次重要會議結束後提供後續措施的最新情況。”

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.

該演講的標題是 “使用Rademikibart觀察到中度至重度不受控制的哮喘(CBP-201-WW002)患者肺功能和哮喘控制得到改善”,重點介紹了這一點 2023 年 12 月公佈的 2b 期試驗結果 這表明,兩種劑量的rademikibart都使支氣管擴張劑(BD)前強制呼氣量在一秒以上(FEV)的顯著改善1) 在第 12 周使用兩劑 rademikibart。此外,與使用rademikibart的安慰劑相比,顯著的改善早在第一週就開始了,並持續了24周的治療。一項預先定義的探索性分析顯示,嗜酸性粒細胞水平≥300個細胞/μl的患者的肺功能得到進一步改善。患者報告的哮喘控制迅速得到顯著改善,並持續了24周的治療。

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 50% and prolonged time to exacerbation were observed.

此外,儘管該研究無法發現治療組之間惡化的差異,但觀察到年化發作減少約50%和惡化時間延長的強勁趨勢。

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.

該公司計劃在2024年第二季度與美國食品藥品管理局舉行EoP2會議,討論rademikibart的第三階段監管路徑。海報演示文稿的副本將在Connect Biopharma的網站上公佈,位於”我們的科學“部分。

About Connect Biopharma Holdings Limited

關於 Connect 生物製藥控股有限公司

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/

Connect Biopharma是一家全球性的臨床階段生物製藥公司,運用其在T細胞生物學方面的專業知識和對藥物發現行業的深入了解,開發治療慢性炎症性疾病的創新療法,目標是改善全球數百萬受影響者的生活。該公司正在建立豐富的專有小分子和抗體產品線,使用功能性T細胞檢測,對照經過驗證的免疫靶標篩選和發現有效的候選產品。該公司的主要候選產品rademikibart(前身爲 CBP-201)是一種抗體,旨在靶向正在開發的用於治療特應性皮炎(AD)和哮喘的白介素-4受體α受體(IL-4Rα)。該公司的第二種候選產品icanbelimod(前身爲 CBP-307)是S1P1 T細胞受體的調節劑,正在開發用於治療潰瘍性結腸炎(UC)。欲了解更多信息,請訪問: https://www.connectbiopharm.com/

Forward-Looking Statements

前瞻性陳述

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.

Connect Biopharma警告說,本新聞稿中包含的未描述歷史事實的陳述均爲前瞻性陳述。諸如 “可能”、“可以”、“將”、“將”、“應該”、“期望”、“計劃”、“預測”、“相信”、“估計”、“打算”、“預測”、“尋求”、“考慮”、“展望”、“潛在”、“繼續” 或 “項目” 等詞語或這些術語或其他類似術語的否定詞旨在識別前瞻性陳述。這些陳述包括公司推進候選產品開發的計劃,實現任何開發、監管或商業里程碑或報告數據的時機,或是否將實現或生成此類里程碑或數據,包括是否提交或接受任何新藥申請及其時間,以及此類候選產品的潛力,包括實現任何收益、改進、差異化、趨勢或概況或任何產品批准或生效,以及公司的識別和參與能力在任何戰略合作伙伴關係中,公司在大中華區的合作伙伴關係是否符合預期,以及公司的現金和投資是否足以支持計劃運營。Connect Biopharma不應將納入前瞻性陳述視爲其任何計劃都將實現的陳述。由於公司業務固有的風險和不確定性以及公司向美國證券交易委員會(SEC)提交的文件(包括公司於2024年4月16日向美國證券交易委員會提交的20-F表年度報告及其其他報告)中描述的其他風險,實際數據可能與本新聞稿中列出的數據存在重大差異。提醒投資者不要過分依賴這些前瞻性陳述,這些陳述僅代表截至本文發佈之日,Connect Biopharma沒有義務修改或更新本新聞稿以反映本新聞發佈之日之後的事件或情況。有關這些風險和其他風險的更多信息包含在Connect Biopharma向美國證券交易委員會提交的文件中,這些文件可在美國證券交易委員會的網站(www.sec.gov)和Connect Biopharma的網站(www.connectbiopharm.com)的 “投資者” 標題下查閱。本警示性陳述對所有前瞻性陳述進行了全面的限定。這種謹慎是根據1995年《私人證券訴訟改革法》第21E條的安全港條款做出的。

INVESTOR CONTACT:

投資者聯繫人:

Tim McCarthy

蒂姆·麥卡錫

LifeSci Advisors

生命科學顧問

譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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