PhaseBio Announces Completion of Phase 2a Clinical Trial of PB2452 for the Reversal of the Antiplatelet Activity of Ticagrelor
PhaseBio Announces Completion of Phase 2a Clinical Trial of PB2452 for the Reversal of the Antiplatelet Activity of Ticagrelor
MALVERN, Pa. and SAN DIEGO, Sept. 24, 2019 (GLOBE NEWSWIRE) -- PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary orphan diseases, today announced the completion of its Phase 2a clinical trial of PB2452. Full data from the trial are planned to be presented at an upcoming medical congress. Press Release: PhaseBio Announces Completion of Phase 2a Clinical Trial of PB2452 for the Reversal of the Antiplatelet Activity of Ticagrelor
新聞稿：PhaseBio公司宣佈完成PB2452逆轉替卡格雷抗血小板活性的2a期臨牀試驗
PhaseBio Announces Completion of Phase 2a Clinical Trial of PB2452 for the Reversal of the Antiplatelet Activity of Ticagrelor
PhaseBio公司宣佈完成PB2452逆轉替卡格雷抗血小板活性的2a期臨牀試驗
Preliminary Results from Supratherapeutic-Dose Ticagrelor Cohort Are Consistent with Earlier Phase 2a Cohorts and Previously Published Phase 1 Trial
超治療劑量替卡格雷隊列試驗的初步結果與早期2a期隊列和先前發表的1期試驗一致
MALVERN, Pa. and SAN DIEGO, Sept. 24, 2019 (GLOBE NEWSWIRE) -- PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary orphan diseases, today announced the completion of its Phase 2a clinical trial of PB2452. Full data from the trial are planned to be presented at an upcoming medical congress.
賓夕法尼亞州馬爾文和聖迭戈，9月2019年2月24日(環球網)--專注於心肺孤兒疾病新療法開發和商業化的臨牀階段生物製藥公司PhaseBio PharmPharmticals，Inc.(納斯達克股票代碼：PHAS)今天宣佈，其PB2452的2a期臨牀試驗已經完成。試驗的全部數據計劃在即將到來的醫學大會上公佈。
In the trial, PB2452 achieved immediate and sustained reversal of ticagrelor in older (ages 50-64) and elderly (ages 65-80) subjects on dual antiplatelet therapy of ticagrelor and low-dose aspirin. PB2452 was generally well tolerated, with only minor adverse events reported. These results are consistent with the results observed in healthy younger subjects treated with ticagrelor in the previously published Phase 1 trial. The older and elderly subjects in the Phase 2a trial resemble the patient population most likely to be treated with ticagrelor and to potentially benefit from PB2452, if approved.
在試驗中，PB2452在接受替卡格雷和小劑量阿司匹林雙重抗血小板治療的老年(50-64歲)和老年(65-80歲)受試者中實現了替卡格雷的即時和持續逆轉。PB2452總體耐受性良好，僅有輕微不良反應報告。這些結果與先前發表的第1階段試驗中使用替卡格雷治療的健康年輕受試者的觀察結果一致。2a階段試驗中的老年人和老年受試者類似於最有可能接受替卡格雷治療並可能從PB2452中受益的患者羣體，如果獲得批准。
Based on guidance provided by the U.S. Food and Drug Administration ("FDA") during the PB2452 End-of-Phase 1 meeting in July of this year, the Phase 2a trial also investigated a PB2452 regimen for the reversal of supratherapeutic doses of ticagrelor in healthy younger subjects. In the supratherapeutic-dose cohort, PB2452 demonstrated immediate and sustained reversal of ticagrelor and was well tolerated, consistent with the earlier cohorts in the Phase 2a and Phase 1 trials. Statistically significant reversal of the antiplatelet activity of supratherapeutic blood levels of ticagrelor was achieved within 5 minutes of initiation of PB2452 infusion and sustained for 24 hours. Platelet function was normalized by 30 minutes following initiation of PB2452 infusion and remained normal for 24 hours. Based on the preliminary results from this cohort, PhaseBio believes that it has identified an appropriate PB2452 regimen for use in patients who may have supratherapeutic blood levels of ticagrelor as a result of ticagrelor drug-drug interactions or overdosage.
根據美國食品和藥物管理局(FDA)在今年7月PB2452第一階段結束會議期間提供的指導，2a期試驗還研究了PB2452方案在健康的年輕受試者中逆轉替卡格雷超治療劑量的情況。在超過治療劑量的隊列中，PB2452顯示替卡格雷立即和持續逆轉，耐受性良好，與2a期和1期試驗中的早期隊列一致。替卡格雷超治療血藥濃度的抗血小板活性在PB2452開始輸注後5分鐘內顯著逆轉，並持續24小時。血小板功能在PB2452輸注開始後30分鐘內恢復正常，並持續24小時。根據這一隊列的初步結果，PhaseBio公司認為，它已經確定了一種適當的PB2452方案，用於可能因替卡格雷藥物相互作用或過量而導致血液中替卡格雷水平高於治療水平的患者。
"With the successful completion of our Phase 1 and 2a studies, we are excited to be moving forward into our registrational studies for PB2452," said John Lee, M.D., Ph.D., Chief Medical Officer of PhaseBio. "Our defined regulatory path for PB2452 remains on track as we prepare to advance the program into a Phase 2b trial in the fourth quarter of this year and a pivotal Phase 3 trial in the first quarter of 2020. We continue to be encouraged about the potential of PB2452 to address a significant unmet need for patients by reversing the antiplatelet activity of ticagrelor in major bleeding and urgent surgery situations."
PhaseBio公司首席醫療官李家超説：“隨着我們第1階段和2a階段研究的成功完成，我們很高興能夠進入我們對PB2452的註冊研究。我們為PB2452確定的管理路徑仍在軌道上，因為我們準備將該計劃推進到今年第四季度的2b階段試驗和2020年第一季度的關鍵第三階段試驗。我們繼續對PB2452通過在重大出血和緊急手術情況下逆轉替卡格雷的抗血小板活性來滿足患者的重大未得到滿足的需求的潛力感到鼓舞。“
Additional information on the trial can be found on www.ClinicalTrials.gov using the identifier NCT03928353.
有關該試驗的更多信息，請訪問www.Clinicaltrials.gov，使用識別符NCT03928353。
About PB2452
關於PB2452
PB2452 is a novel, recombinant, human monoclonal antibody antigen-binding fragment, or Fab, designed to reverse the antiplatelet activity of ticagrelor in major bleeding and urgent surgery situations. In a Phase 1 clinical trial, PB2452 demonstrated the potential to bring life-saving therapeutic benefit through immediate and sustained reversal of ticagrelor's antiplatelet activity, mitigating concerns regarding bleeding risks associated with the use of antiplatelet drugs. The Phase 1 clinical trial of PB2452 in healthy volunteers was published in the New England Journal of Medicine in March 2019.(1) In April 2019, PB2452 received Breakthrough Therapy designation from the FDA. Breakthrough Designation may be granted by FDA when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapy. PhaseBio plans to initiate a single pivotal Phase 3 clinical trial of PB2452 in the first quarter of 2020 to support a Biologics License Application for PB2452 in both major bleeding and surgery indications. There are currently no approved reversal agents for ticagrelor or any other antiplatelet drugs.
PB2452是一種新型的重組人單抗抗原結合片段，或稱Fab，旨在逆轉替卡格雷在大出血和緊急手術情況下的抗血小板活性。在一期臨牀試驗中，PB2452證明瞭通過立即和持續地逆轉替卡格雷的抗血小板活性，帶來挽救生命的治療益處的潛力，減輕了人們對使用抗血小板藥物相關出血風險的擔憂。PB2452在健康志願者中的第一階段臨牀試驗於2019年3月發表在《新英格蘭醫學雜誌》上。(1)2019年4月，PB2452獲得FDA的突破性治療稱號。當初步臨牀證據表明該藥物可能比現有療法有實質性改善時，FDA可能會授予突破性指定。PhaseBio計劃在2020年第一季度啟動PB2452的單一關鍵3期臨牀試驗，以支持PB2452在主要出血和手術適應症方面的生物製品許可證申請。目前還沒有批准的替卡格雷或任何其他抗血小板藥物的逆轉藥物。
About PhaseBio
關於PhaseBio
PhaseBio Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies to treat orphan diseases, with an initial focus on cardiopulmonary disorders. The company's lead development candidate is PB2452, a novel reversal agent for the antiplatelet therapy ticagrelor. PhaseBio is also leveraging its proprietary elastin-like polypeptide ("ELP") technology platform to develop therapies with the potential for less-frequent dosing and improved pharmacokinetics. PhaseBio's second product candidate PB1046, which is based on ELP, is a once-weekly vasoactive intestinal peptide receptor agonist for the treatment of pulmonary arterial hypertension.
PhaseBio製藥公司是一家臨牀階段的生物製藥公司，專注於治療孤兒疾病的新療法的開發和商業化，最初的重點是心肺疾病。該公司的主要開發候選藥物是PB2452，這是一種用於抗血小板治療的新型逆轉劑替卡格雷。PhaseBio還利用其專有的彈性蛋白樣多肽(ELP)技術平臺開發具有減少劑量和改善藥代動力學的潛力的療法。PhaseBio公司的第二個候選產品PB1046基於ELP，是一種每週一次的血管活性腸肽受體激動劑，用於治療肺動脈高壓。
PhaseBio is located in Malvern, PA and San Diego, CA. For more information, please visit www.phasebio.com.
PhaseBio公司位於賓夕法尼亞州馬爾文和加利福尼亞州聖地亞哥。欲瞭解更多信息，請訪問www.phaseBio.com。
Forward-Looking Statements
前瞻性陳述
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," and "future" or similar expressions are intended to identify forward-looking statements.
本新聞稿包含符合1995年私人證券訴訟改革法的前瞻性陳述。諸如“預期”、“相信”、“期望”、“打算”、“項目”和“未來”等詞語或類似的表達方式旨在識別前瞻性陳述。
Forward-looking statements include statements concerning or implying the conduct or timing of our clinical trials and our research, development and regulatory plans for PB2452, PB1046 and our ELP research programs. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements.
前瞻性陳述包括有關或暗示我們的臨牀試驗以及我們針對PB2452、PB1046和ELP研究計劃的研究、開發和監管計劃的進行或時間安排的陳述。前瞻性陳述基於管理層目前的預期，會受到各種風險和不確定因素的影響，這些風險和不確定性可能會導致實際結果與這些前瞻性陳述明示或暗示的結果大相徑庭。因此，這些前瞻性陳述並不構成對未來業績的保證，請不要過分依賴這些前瞻性陳述。
Risks regarding our business are described in detail in our Securities and Exchange Commission filings, including in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2019. These forward-looking statements speak only as of the date hereof, and PhaseBio Pharmaceuticals, Inc. disclaims any obligation to update these statements except as may be required by law.
關於我們業務的風險在我們提交給美國證券交易委員會的文件中有詳細的描述，包括我們在截至2019年6月30日的季度10-Q表格中的季度報告。這些前瞻性陳述僅在本新聞稿發佈之日發表，PhaseBio製藥公司不承擔更新這些陳述的義務，除非法律另有要求。
Investor Contact:
投資者聯繫方式：
John Sharp
約翰·夏普
PhaseBio Pharmaceuticals, Inc.
PhaseBio製藥公司
Chief Financial Officer
首席財務官
(610) 981-6506
(610) 981-6506
john.sharp@phasebio.com
郵箱：john.Sharp@phaseBio.com
Media Contact:
媒體聯繫人：
Gina Cestari
吉娜·塞斯塔裏
6 Degrees
6度
(917) 797-7904
(917) 797-7904
gcestari@6degreespr.com
郵箱：gcestari@6dederespr.com
_______________________________________
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1. Bhatt DL, Pollack CV, Weitz JI, et al. Antibody-Based Ticagrelor Reversal
Agent in Healthy Volunteers. N Engl J Med 2019;Mar 17.
1.Bhatt DL，Pollack CV，Weitz Ji等人。基於抗體的替卡格雷逆轉
健康志願者中的代理。N Engl J Med 2019；3月17日。
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(完)道瓊斯通訊社
September 24, 2019 16:01 ET (20:01 GMT)
2019年9月24日東部時間16：01(格林尼治標準時間20：01)
*DJ PhaseBio Announces Completion of Phase 2a Clinical Trial of PB2452 for the Reversal of the Antiplatelet Activity of Ticagrelor
*DJ PhaseBio宣佈完成PB2452逆轉替卡格雷抗血小板活性的2a期臨牀試驗
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