MALVERN, Pa. and SAN DIEGO, June 17, 2019 (GLOBE NEWSWIRE) — PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), 一家临床阶段的生物制药公司，专注于孤儿疾病的新疗法的开发和商业化, today announced preliminary data from its Phase 2a clinical trial of PB2452, 哪个是PB2452首次将替格瑞洛和低剂量阿司匹林双重抗血小板治疗纳入老年(50-64岁)和老年(65-80岁)受试者的试验. 试验中的受试者与最有可能接受替格瑞洛治疗的患者群体相似，并可能从PB2452中获益, if approved. In the trial, 在PB2452输注开始5分钟内，替格瑞洛的逆转达到了统计学意义上的显著水平，并持续了20小时以上. PB2452输注后15分钟血小板功能恢复正常，持续20小时以上. To date, PB2452 has been generally well tolerated in the Phase 2a trial, with only minor adverse events reported. 这些新数据与PhaseBio之前发表的第一阶段试验结果一致，该试验是在健康的年轻志愿者中进行的，仅使用替格瑞洛而非阿司匹林治疗. 在2a期试验中，PB2452的疗效采用与1期试验相同的三种方法进行测量, 所有三种分析的结果都显示了两种试验的高度相关性.
“For patients taking antiplatelet therapies such as ticagrelor, 目前建议患者在手术前至少停止抗血小板治疗5天，以降低大出血的风险,” said John Lee, M.D., Ph.D., Chief Medical Officer of PhaseBio. “This isn’t an option for patients requiring urgent or emergency surgery. For patients experiencing major bleeding, there are currently no proven methods to reverse the effects of antiplatelet agents. If approved, PB2452可以通过提高替格瑞洛的安全性来帮助解决这些关键的未得到满足的医疗需求, 哪一种有潜力成为市场上唯一一种具有特定逆转剂的抗血小板疗法. 彩乐园2期待在即将召开的医学大会上报告2a期试验的完整结果.”
Additional information on the trial can be found on www.ClinicalTrials.gov using the identifier NCT03928353.
About PB2452
PB2452 is a novel, recombinant, human monoclonal antibody antigen-binding fragment, or Fab fragment, 用于逆转替格瑞洛在大出血和紧急手术情况下的抗血小板活性. In a Phase 1 clinical trial, 通过立即和持续逆转替格瑞洛的抗血小板活性，PB2452显示出可能带来挽救生命的治疗效益, 减轻对使用抗血小板药物相关出血风险的担忧. PB2452在健康志愿者中的1期临床试验被选择为一项迟来的突破, oral presentation at The American College of Cardiology’s Annual Scientific Session1 and published simultaneously in the New England Journal of Medicine in March 2019.2 In April 2019, PB2452 received Breakthrough Therapy designation from the U.S. Food and Drug Administration (“FDA”). 当初步临床证据表明该药物可能比现有疗法有实质性改善时，FDA可能会授予突破性药物称号. 目前尚无替格瑞洛或任何其他抗血小板药物的逆转剂得到批准.
About PhaseBio
PhaseBio Pharmaceuticals, Inc. 临床阶段的生物制药公司是否专注于孤儿病的新疗法的开发和商业化, 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还利用其专利的弹性蛋白多肽(ELP)技术平台，开发具有较少频繁给药和改善药代动力学潜力的疗法. PhaseBio’s second product candidate PB1046, which is based on ELP, 每周一次的血管活性肠肽受体激动剂是否可用于肺动脉高压的治疗.
PhaseBio is located in Malvern, PA and San Diego, CA. For more information, please visit www.phasebio.com.
Forward-Looking Statements
本彩乐园2稿包含1995年《彩乐园1app》所指的前瞻性陈述. Words such as “anticipates,” “believes,” “expects,” “intends,” “projects,和“未来”或类似的表述旨在确定前瞻性陈述.
前瞻性陈述包括关于或暗示彩乐园2临床试验的进行或时间的陈述和彩乐园2的PB2452, PB1046和ELP研究项目的研发和监管计划. 前瞻性陈述以管理层目前的期望为基础，并受到各种风险和不确定性的影响，这些风险和不确定性可能导致实际结果与此类前瞻性陈述所表达或暗示的实际结果有重大和不利的差异. Accordingly, these forward-looking statements do not constitute guarantees of future performance, 并且你被警告不要过分依赖这些前瞻性的陈述.
彩乐园2在提交给美国证券交易委员会(Securities and Exchange Commission)的文件中详细描述了彩乐园2业务的风险, including in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2019. 这些前瞻性声明仅在本协议日期生效，PhaseBio Pharmaceuticals, Inc .. 除法律要求外，彩乐园2不承担更新这些声明的任何义务.
Investor Contact:
John Sharp
PhaseBio Pharmaceuticals, Inc.
Chief Financial Officer
(610) 981-6506
john.sharp@phasebio.com
Media Contact:
Gina Cestari
6 Degrees
(917) 797-7904
gcestari@6degreespr.com
- http://www.acc.org/latest-in-cardiology/clinical-trials/2019/03/15/21/37/ticagrelor-reversal-agent
- Bhatt DL, Pollack CV, Weitz JI, et al. Antibody-Based Ticagrelor Reversal Agent in Healthy Volunteers. N Engl J Med 2019;Mar 17.
Source: PhaseBio Pharmaceuticals, Inc.