SAN DIEGO--(BUSINESS WIRE)--Endeavor BioMedicines, a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases, announced that data from a completed Phase 2a clinical trial evaluating the company’s lead investigational candidate ENV-101 in patients with idiopathic pulmonary fibrosis (IPF) will be presented for the first time in a late-breaking oral session at the American Thoracic Society 2024 (ATS 2024) International Conference.

圣地亚哥--（商业新闻短讯）--Endeavor BioMedicines是一家临床阶段的生物技术公司，开发药物，有可能为危及生命的疾病患者提供转化性临床益处，该公司宣布，一项已完成的2a期临床试验的数据将首次在美国胸科学会2024（ATS 2024）国际会议的最新口头会议上提交，该试验评估该公司针对特发性肺纤维化（IPF）患者的主要研究候选药物ENV-101。

ATS 2024 will take place May 17-22, 2024, in San Diego..

2024年ATS将于2024年5月17日至22日在圣地亚哥举行。。

The Phase 2a, randomized, double-blind, placebo-controlled clinical trial (NCT04968574) evaluated the safety and efficacy of ENV-101 vs. placebo in 41 patients with confirmed IPF who were treated for 12 weeks.

2a期随机双盲安慰剂对照临床试验（NCT04968574）评估了41例确诊IPF患者接受12周治疗后ENV-101与安慰剂的安全性和有效性。

Following are details about the ENV-101 oral presentation at ATS 2024:

以下是ENV-101在ATS 2024上的口头演示的详细信息：

Title: ENV-101, A Novel Hedgehog Inhibitor, Increases Lung Function, and Reduces Lung Fibrosis in Patients With Idiopathic Pulmonary Fibrosis: Results From a Randomized, Double-blind, Placebo-controlled Phase 2 Trial

标题：新型刺猬抑制剂ENV-101可增加特发性肺纤维化患者的肺功能并减少肺纤维化：一项随机，双盲，安慰剂对照的2期临床试验的结果

Presenter: Toby M. Maher, M.D., Ph.D., Professor of Medicine and Director of Interstitial Lung Disease at Keck School of Medicine, University of Southern California, Los Angeles

主持人：Toby M.Maher，医学博士，博士，洛杉矶南加州大学凯克医学院医学教授兼间质性肺病主任

Session: A-18 – Fixing What’s Broken: Novel Therapeutics for Lung Remodeling

课程：A-18–修复破损：肺重塑的新疗法

Date and Time: May 19, 2024, 10:51-11:03 a.m. PT

日期和时间：2024年5月19日上午10:51-11:03 PT

Location: San Diego Convention Center, Room 8 (Upper Level)

地点：圣地亚哥会议中心8室（上层）

“We look forward to sharing the results from the Phase 2a trial of ENV-101 with the pulmonology community for the first time at ATS 2024,” said Paul A. Frohna, M.D., Ph.D., Pharm.D., Chief Medical Officer, Endeavor BioMedicines. “There is a tremendous need for new therapies that have the potential to reverse lung fibrosis and improve lung function in patients with IPF, and these data suggest ENV-101 could be an important new option for patients.”.

“我们期待着在ATS 2024上首次与肺病学界分享ENV-101 2a期试验的结果，”奋进生物医学首席医学官Paul A.Frohna博士说。“非常需要有可能逆转IPF患者肺纤维化和改善肺功能的新疗法，这些数据表明ENV-101可能是患者的重要新选择。”。

ENV-101 blocks a cellular wound-healing pathway known as Hedgehog (Hh) that is abnormally activated in fibrotic lung diseases such as IPF and causes the buildup of scar tissue in the lungs. Current standard-of-care therapies do not address the underlying cause of IPF. They slow the decline of lung function, but do not stop or reverse it, and they have tolerability issues that limit their long-term use in most patients.

ENV-101阻断称为刺猬（Hh）的细胞伤口愈合途径，该途径在纤维化肺病（如IPF）中异常激活，并导致肺部瘢痕组织积聚。目前的护理标准疗法并没有解决IPF的根本原因。它们可以减缓肺功能的下降，但不能阻止或逆转肺功能的下降，而且它们的耐受性问题限制了它们在大多数患者中的长期使用。

Based on results from the Phase 2a trial of ENV-101, Endeavor BioMedicines intends to initiate a Phase 2 trial in patients with IPF and in a parallel cohort, patients with progressive pulmonary fibrosis (PPF), in 2024..

根据ENV-101 2a期试验的结果，奋进生物医学计划于2024年在IPF患者和平行队列进行性肺纤维化（PPF）患者中启动2期试验。。

About Idiopathic Pulmonary Fibrosis

关于特发性肺纤维化

IPF is a chronic, progressive lung disease that affects more than 100,000 adults in the United States. Although the exact cause of IPF is unknown, various environmental factors can deliver repeated injuries to lung cells that trigger abnormal wound-healing processes and life-threatening lung scarring.

IPF是一种慢性进行性肺部疾病，在美国影响超过100000名成年人。尽管IPF的确切原因尚不清楚，但各种环境因素可能会对肺细胞造成反复损伤，从而引发异常的伤口愈合过程和危及生命的肺瘢痕形成。

IPF is a chronic disease with limited treatment options and a very poor prognosis: the average life expectancy is only three to five years after diagnosis..

IPF是一种慢性疾病，治疗选择有限，预后极差：诊断后的平均预期寿命仅为三到五年。。

About ENV-101

关于ENV-101

Endeavor BioMedicines’ investigational medicine ENV-101 is a Hedgehog signaling pathway inhibitor. By binding to and inhibiting a key receptor in the Hedgehog pathway, ENV-101 stops the abnormal accumulation of the myofibroblasts that cause fibrosis. This may resolve the excessive wound-healing process seen in IPF and PPF, creating the potential to reverse fibrosis and improve lung volume and function..

奋进生物医学的研究药物ENV-101是一种刺猬信号通路抑制剂。通过结合并抑制刺猬通路中的关键受体，ENV-101阻止了导致纤维化的肌成纤维细胞的异常积累。这可能会解决IPF和PPF中出现的过度伤口愈合过程，从而有可能逆转纤维化并改善肺容量和功能。。

About Endeavor BioMedicines

关于奋进生物医学

Endeavor BioMedicines is a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases. Endeavor’s lead candidate, ENV-101, is an inhibitor of the Hedgehog signaling pathway in clinical development for the treatment of IPF and PPF.

Endeavor BioMedicines是一家临床阶段的生物技术公司，开发的药物有可能为威胁生命的疾病患者提供变革性的临床益处。Endeavor的主要候选药物ENV-101是临床开发中用于治疗IPF和PPF的刺猬信号通路的抑制剂。

The company’s second candidate, ENV-501, is a HER3 antibody-drug conjugate (ADC) for the treatment of HER3-positive solid tumors. More information is available at www.endeavorbiomedicines.com and on LinkedIn or X..

该公司的第二个候选药物ENV-501是用于治疗HER3阳性实体瘤的HER3抗体-药物偶联物（ADC）。有关更多信息，请访问www.evelorbiomedicines.com和LinkedIn或X。。