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, today announced successful completion of its Phase 2a clinical trial evaluating the company’s lead investigational compound, ENV-101, in patients with idiopathic pulmonary fibrosis (IPF).

圣地亚哥--（商业新闻短讯）--奋进生物医学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的临床益处，今天宣布成功完成其2a期临床试验，评估该公司的主要研究化合物ENV-101，特发性肺纤维化（IPF）患者。

ENV-101 is an oral small molecule inhibitor of the Hedgehog (Hh) signaling pathway that offers a novel approach to treating the underlying pathologic mechanisms that cause fibrotic lung diseases..

ENV-101是刺猬（Hh）信号通路的口服小分子抑制剂，为治疗引起纤维化肺病的潜在病理机制提供了一种新方法。。

“Preliminary results from our Phase 2a trial reinforce our belief that ENV-101 has the potential to be the first ever disease-modifying therapy for IPF,” said John Hood, Ph.D., co-founder, CEO and chairman, Endeavor BioMedicines. “We are hopeful that the therapeutic capability of ENV-101 will offer treatment outcomes that go beyond slowing disease progression for patients with lung fibrosis.”.

Endeavor BioMedicines联合创始人、首席执行官兼主席约翰·胡德（JohnHood）博士说：“我们2a期试验的初步结果强化了我们的信念，即ENV-101有可能成为IPF的第一种疾病缓解疗法。”。“我们希望ENV-101的治疗能力将提供超越减缓肺纤维化患者疾病进展的治疗结果。”。

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

完成的2a期随机双盲安慰剂对照临床试验评估了41例确诊IPF患者接受三个月治疗的ENV-101与安慰剂的安全性和有效性。

“We plan to present the full data from this study at an upcoming medical conference,” said Paul Frohna, M.D., Ph.D., chief medical officer, Endeavor BioMedicines. “Additionally, we look forward to expanding ENV-101 clinical development activity by initiating a randomized, double-blind, dose-ranging Phase 2b trial in patients with IPF and in a parallel cohort of patients with progressive fibrosing-interstitial lung disease in 2024 to evaluate its broader therapeutic potential.”.

“我们计划在即将举行的医学会议上展示这项研究的全部数据，”奋进生物医学首席医学官保罗·弗罗纳（PaulFrohna）博士说。“此外，我们期待通过在2024年对IPF患者和进行性纤维化间质性肺病患者的平行队列中启动一项随机，双盲，剂量范围2b期试验来扩大ENV-101临床开发活动，以评估其更广泛的治疗潜力。”。

ENV-101 binds to and inhibits a key receptor in the Hh cellular pathway, blocking Hh signaling and inhibiting the pathway. This resolves the excessive wound healing process seen in IPF and progressive fibrosing-interstitial lung disease (PF-ILD), potentially stopping or reversing fibrosis and lung tissue remodeling and, as a result, potentially reversing the disease trajectory..

ENV-101结合并抑制Hh细胞途径中的关键受体，阻断Hh信号传导并抑制该途径。这解决了IPF和进行性纤维化间质性肺病（PF-ILD）中出现的过度伤口愈合过程，可能阻止或逆转纤维化和肺组织重塑，因此可能逆转疾病轨迹。。

About Idiopathic Pulmonary Fibrosis

关于特发性肺纤维化

Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive disease that causes lung tissue to become thickened, stiff and scarred, eventually reducing the lungs’ ability to transfer oxygen into the bloodstream. There are more than 100,000 people affected by IPF in the U.S. alone, and average life expectancy is only three to five years after diagnosis.

特发性肺纤维化（IPF）是一种慢性进行性疾病，会导致肺组织增厚，僵硬和疤痕，最终降低肺部将氧气转移到血液中的能力。仅在美国就有超过10万人受到IPF的影响，平均预期寿命仅为诊断后的3至5年。

The limited treatment options currently available for IPF don’t address the underlying cause of the disease and only slow the decline of lung function..

目前可用于IPF的有限治疗选择并不能解决疾病的根本原因，只能减缓肺功能的下降。。

About ENV-101

关于ENV-101

ENV-101 is an oral small molecule inhibitor of the Hedgehog (Hh) signaling pathway that offers an entirely new mechanism of action for treating IPF. The Hh pathway is rarely active in adults except in wound healing and scar formation. Aberrant activation of the Hh pathway through repeated environmental injury to specific lung cells causes excessive fibrotic matrix to accumulate, forming scar tissue and resulting in an inelastic, contracted lung and loss of lung function..

ENV-101是刺猬（Hh）信号通路的口服小分子抑制剂，为治疗IPF提供了全新的作用机制。除了伤口愈合和瘢痕形成外，Hh途径在成人中很少活跃。通过对特定肺细胞的反复环境损伤异常激活Hh途径，导致过度纤维化基质积聚，形成瘢痕组织，导致肺无弹性收缩和肺功能丧失。。

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 (Hh) signaling pathway in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and progressive fibrosing-interstitial lung disease (PF-ILD).

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特发性肺纤维化（IPF）和进行性纤维化间质性肺病（PF-ILD）的刺猬（Hh）信号通路的抑制剂。

Their second candidate, ENV-501, is a HER3-antibody drug conjugate (ADC) for the treatment of HER3-positive solid tumors. Endeavor has assembled a highly credentialed leadership team with deep experience identifying promising drug candidates and developing them into leading medicines. More information is available at www.endeavorbiomedicines.com and on LinkedIn or X..

他们的第二个候选者ENV-501是用于治疗HER3阳性实体瘤的HER3抗体-药物缀合物（ADC）。Endeavor已经组建了一个拥有丰富经验的高度认证的领导团队，以确定有前途的候选药物并将其开发成领先的药物。有关更多信息，请访问www.evelorbiomedicines.com和LinkedIn或X。。