Data from 13 participants presented at the American Transplant Congress continue to support safety and tolerability profile of tegoprubart

在美国移植大会上提交的13名参与者的数据继续支持替戈普巴特的安全性和耐受性概况

Overall mean eGFR of all reported time points after day 30 post-transplant of 70.5 mL/min/1.73m²

移植后第30天所有报告时间点的总体平均eGFR为70.5 mL/min/1.73m²

Mean eGFR measured above 60 mL/min/1.73m² at all reported time points after day 30 post-transplant

移植后第30天，在所有报告的时间点，平均eGFR均高于60 mL/min/1.73m²

IRVINE, Calif., June 03, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today presented updated data from the Company’s ongoing open-label Phase 1b trial and open-label extension study evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients.

加利福尼亚州欧文市，2024年6月3日（环球通讯社）--Eledon Pharmaceuticals，Inc.（“Eledon”）（纳斯达克：ELDN）今天提供了该公司正在进行的开放标签1b期试验和开放标签扩展研究的最新数据，该研究评估了替戈鲁巴特预防肾移植患者器官排斥反应的作用。

Results from the poster, titled “Biomarkers of Inflammation and eGFR in an Ongoing Phase 1B Study of an Anti-CD40L Antibody Tegoprubart, for the Prevention of Rejection in Kidney Transplant,” were presented at the American Transplant Congress (ATC) taking place in Philadelphia, PA from June 1-5, 2024..

该海报的结果于2024年6月1日至5日在宾夕法尼亚州费城举行的美国移植大会（ATC）上发布，标题为“正在进行的抗CD40L抗体替戈普巴特1B期研究中的炎症和eGFR生物标志物，用于预防肾移植排斥反应”。。

“Eledon continues to build a robust set of encouraging results demonstrating the safety and efficacy of tegoprubart in kidney transplant recipients in our Phase 1b trial,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “Calcineurin inhibitors, the current standard of care, do not adequately serve the transplant community due to frequent and difficult–to-manage side effects.

Eledon首席执行官David Alexandre C.Gros医学博士说：“在我们的1b期临床试验中，Eledon继续取得了一系列令人鼓舞的结果，证明了替戈鲁巴特在肾移植受者中的安全性和有效性。”。“钙调神经磷酸酶抑制剂是目前的护理标准，由于频繁且难以控制副作用，因此不能充分服务于移植社区。

By contrast, tegoprubart’s observed clinical profile to date gives us confidence in its potential to supplant calcineurin inhibitors as a next-generation immunosuppression agent for patients who have received a new kidney. We look forward to accruing incremental data through the ongoing Phase 1b and open-label extension studies while continuing to enroll in our Phase 2 BESTOW trial, with enrollment completion anticipated by the end of the year.”.

相比之下，迄今为止，替戈普巴特观察到的临床特征使我们对其替代钙调神经磷酸酶抑制剂作为接受新肾脏治疗的患者的下一代免疫抑制剂的潜力充满信心。我们期待着通过正在进行的1b期和开放标签扩展研究积累增量数据，同时继续参加我们的第2期PONDER试验，预计年底将完成注册。”。

As of the April 2024 cutoff date, updated data from the 13 participants in the ongoing Phase 1b trial support tegoprubart’s potential to protect organ function in patients undergoing kidney transplantation. Data from historical studies using standard of care, calcineurin inhibitor-based immunosuppression therapy typically report aggregate mean estimated glomerular filtration rates (eGFRs) of approximately 50 mL/min/1.73m2 during the first year after kidney transplant.

截至2024年4月的截止日期，正在进行的1b期临床试验的13名参与者的最新数据支持替戈普巴特保护肾移植患者器官功能的潜力。使用基于钙调神经磷酸酶抑制剂的免疫抑制治疗标准的历史研究数据通常报告肾移植后第一年的总平均估计肾小球滤过率（eGFR）约为50 mL/min/1.73m2。

In the ongoing Phase 1b trial, mean eGFR was above 60 mL/min/1.73m² at each reported time points after day 30, with an overall mean eGFR of 70.5 mL/min/1.73m² for all the reported time points after day 30 post-transplant. Two participants completed 12 months on therapy post-transplant, and both demonstrated mean eGFRs above 90 mL/min/1.73m² at one-year post-transplant..

在正在进行的1b期试验中，在第30天后的每个报告时间点，平均eGFR均高于60 mL/min/1.73m²，在移植后第30天的所有报告时间点，总体平均eGFR为70.5 mL/min/1.73m²。两名参与者在移植后完成了12个月的治疗，并且在移植后一年均显示平均eGFR高于90 mL/min/1.73m²。。

Results demonstrated that tegoprubart is generally safe and well tolerated in patients undergoing de novo kidney transplantation. Three subjects have discontinued the study due to hair loss and fatigue, viral infection, and rejection, respectively. There have been no cases of hyperglycemia, new onset diabetes, or tremor, all of which are side effects often associated with standard of care immunosuppression therapy.

结果表明，在接受从头肾移植的患者中，替戈鲁巴特通常是安全且耐受性良好的。三名受试者分别由于脱发和疲劳，病毒感染和排斥而停止了研究。没有高血糖，新发糖尿病或震颤的病例，所有这些都是通常与标准护理免疫抑制治疗相关的副作用。

There have been no cases of graft loss or death..

没有移植物丢失或死亡的病例。。

Eledon is currently conducting a Phase 1b trial (NCT05027906), a Phase 2 trial (BESTOW; NCT05983770), and a long-term safety and efficacy extension study (NCT06126380) to evaluate tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant.

Eledon目前正在进行一项1b期试验（NCT05027906），一项2期试验（PONDE；NCT05983770）和一项长期安全性和有效性扩展研究（NCT06126380），以评估替戈鲁巴预防接受肾移植的患者器官排斥反应。

A copy of the ATC poster can be found on the Investor section of the Company’s website at https://ir.eledon.com/news-and-events/publications-and-presentations.

ATC海报的副本可在公司网站的投资者部分找到，网址为https://ir.eledon.com/news-and-events/publications-and-presentations.

About Eledon Pharmaceuticals and tegoprubart

关于Eledon Pharmaceuticals和Tegorubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS).

Eledon Pharmaceuticals，Inc.是一家临床阶段生物技术公司，正在开发用于管理和治疗威胁生命的疾病的免疫调节疗法。该公司的主要研究产品是替戈鲁巴特，一种对CD40配体具有高亲和力的抗CD40L抗体，CD40配体是一种经过充分验证的生物靶标，具有广泛的治疗潜力。CD40L信号在适应性和先天性免疫细胞活化和功能中的核心作用使其成为非淋巴细胞消耗，免疫调节治疗干预的有吸引力的靶标。该公司基于抗CD40配体生物学的深厚历史知识，在肾同种异体移植，异种移植和肌萎缩侧索硬化症（ALS）中进行临床前和临床研究。

Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com..

Eledon总部位于加利福尼亚州欧文市。欲了解更多信息，请访问公司网站www.eledon.com。。

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

关注社交媒体上的Eledon Pharmaceuticals:LinkedIn；推特

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, expected or future results of tegoprubart trials and its ability to prevent rejection in connection with kidney transplantation, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

本新闻稿包含前瞻性声明，涉及重大风险和不确定性。关于公司未来预期、计划和前景的任何陈述，包括关于计划的临床试验、候选产品的开发、开始未来临床试验的预期时间、接收临床试验数据的预期时间、替戈普巴特试验的预期或未来结果及其防止肾移植排斥反应的能力的陈述，以及包含“相信”、“预期”、“计划”、“预期”、“估计”、“打算”、“预测”、“项目”、“目标”、“展望”、“可能”、“可能”和类似表述的其他陈述，构成1995年《私人证券诉讼改革法》含义内的前瞻性陈述。

Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sites, as well as patient enrollment; and risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials.

前瞻性陈述本质上是不确定的，并且受到许多风险和不确定性的影响，包括：与我们的候选药物的安全性和有效性有关的风险；与临床开发时间表有关的风险，包括与监管机构和临床网站的互动以及患者登记；以及与临床试验成本和公司资本资源充足性有关的风险，以资助计划的临床试验。

Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S.

由于各种因素的影响，实际结果可能与此类前瞻性声明所显示的结果存在重大差异。这些风险和不确定性，以及其他可能导致公司实际业绩与本文所含前瞻性报表明显不同的风险和不确定性，在我们的季度10-Q、年度10-K和其他提交给美国的文件中进行了讨论。S。

Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking stat.

证券交易委员会，可在www.sec.gov上找到。任何前瞻性统计数据。

Investor Contact:

投资者联系人：

Stephen Jasper

斯蒂芬·贾斯珀

Gilmartin Group

吉尔马丁集团

(858) 525 2047

(858) 525 2047

stephen@gilmartinir.com

stephen@gilmartinir.com

Media Contact:

媒体联系人：

Jenna Urban

Jenna市区

Berry & Company Public Relations

Berry&Company公共关系

(212) 253 8881

(212) 253 8881

jurban@berrypr.com

jurban@berrypr.com

Source: Eledon Pharmaceuticals

来源：Eledon Pharmaceuticals