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IRVINE, Calif., Sept. 05, 2023 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced the first participant has been dosed in the Company’s Phase 2 BESTOW trial evaluating tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant.
加利福尼亚州欧文市,2023年9月5日(GLOBE NEWSWIRE)-Eledon Pharmaceuticals,Inc.(“Eledon”)(纳斯达克股票代码:ELDN)今天宣布第一名参与者已在该公司的第二阶段POWET试验中获得剂量替戈瑞巴用于预防接受肾移植的患者的器官排斥。
BESTOW, a multicenter, two-arm, active comparator clinical study, will enroll approximately 120 participants undergoing kidney transplantation in the United States and other countries to evaluate the safety, pharmacokinetics, and efficacy of the anti-CD40 ligand antibody tegoprubart compared to the calcineurin inhibitor tacrolimus.
POLVE是一项多中心,双臂,积极的比较临床研究,将招募大约120名在美国和其他国家接受肾移植的参与者,以评估抗CD40配体抗体替戈瑞巴特与钙调神经磷酸酶抑制剂他克莫司。
The study’s primary objective is to assess graft function at 12 months post-transplant, as measured by estimated glomerular filtration rate (eGFR) , in participants treated with tegoprubart compared to tacrolimus. Better graft function as assessed by eGFR has been associated with improved long-term patient and graft survival.
该研究的主要目的是评估移植后12个月的移植物功能,通过估计的肾小球滤过率(eGFR)来衡量,与他克莫司相比,接受替格瑞滨治疗的参与者。通过eGFR评估的更好的移植物功能与改善的长期患者和移植物存活相关。
Secondary objectives will include graft survival, biopsy-proven acute rejection, and the incidence of new onset diabetes mellitus after transplant. Eledon will also be using the iBox Scoring System, a composite endpoint of kidney graft function using clinical, histological, and serum biomarkers for the early prediction of graft failure, as an exploratory endpoint.
次要目标将包括移植物存活,活检证实的急性排斥反应以及移植后新发糖尿病的发生率。作为探索性终点,Eledon还将使用iBox评分系统,iBox评分系统是肾移植功能的复合终点,使用临床,组织学和血清生物标志物来早期预测移植失败。
“We are excited to initiate enrollment in the Phase 2 BESTOW clinical trial, a critical next step in our evaluation of tegoprubart as a potential new immunosuppressive regimen to prevent rejection and improve graft function in patients receiving kidney transplants,” said David-Alexandre C. Gros, M.D., Eledon’s Chief Executive Officer.
David Alexandre C.Gros说:“我们很高兴开始参加第二阶段的临床试验,这是我们评估替戈瑞巴作为一种潜在的新型免疫抑制方案来预防排斥反应和改善肾移植患者移植功能的关键下一步。”Eledon首席执行官医学博士。
“This study aims to build on the growing body of evidence, including recently reported results from our Phase 1b trial, reinforcing.
“这项研究旨在建立在越来越多的证据基础上,包括最近报道的我们1b期试验的结果。