Aileron Therapeutics Completes Enrollment for Phase 1b IPF Drug Trial, Topline Data Expected Soon
Aileron Therapeutics Completes Enrollment for Phase 1b IPF Drug Trial, Topline Data Expected Soon
In May 2024, the Company announced positive data from Cohort 1 evaluating low-dose LTI-03 (2.5 mg BID). Following inhaled administration of low-dose LTI-03 in 12 patients, a positive trend was observed in seven out of eight biomarkers with evidence of reduced expression among multiple profibrotic proteins produced by basal-like cells and fibroblasts that contribute to the progression of IPF, including data from three biomarkers that was statistically significant, reinforcing the potential of LTI-03 to improve lung function and reverse the course of IPF.Aileron Therapeutics, Inc. ("Aileron") (NASDAQ:ALRN), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, today announced the completion of enrollment in Cohort 2 of the ongoing Phase 1b clinical trial of LTI-03 in IPF patients.
Aileron Therapeutics公司（"Aileron"）（纳斯达克股票代码:ALRN）是一家生物制药公司，正在推进一系列首创药物，以应对孤立性肺部和纤维化方面的重大医疗需求。今日宣布完成进行中针对IPF患者的LTI-03第十亿临床试验第2队列的招募。
The last patient was enrolled in mid-September, with a total of 24 patients enrolled in the trial. Eligible patients are randomly assigned (3:1) to receive either inhaled LTI-03 or placebo. The primary objective of the trial is to evaluate the safety and tolerability of LTI-03 in patients with IPF after treatment for 14 consecutive days, with measurement of multiple protein biomarkers as exploratory endpoints.
最后一个患者于9月中旬入组，总共有24名患者参与了试验。符合条件的患者将被随机分配（3:1）接受吸入式LTI-03或安慰剂。该试验的首要目标是评估IPF患者在连续治疗14天后接受LTI-03后的安全性和耐受性，并测量多种蛋白质生物标志物作为探索性终点。
"We are pleased to have completed enrollment in the high-dose cohort of our Phase 1b clinical trial and grateful to all participating patients and investigators," said Brian Windsor, Ph.D., President and Chief Executive Officer of Aileron. "Following the positive trend observed in the low-dose cohort, we are excited to assess the safety, tolerability and biomarkers of 5 mg twice daily of inhaled LTI-03 and expect to report topline data in the near term."
"我们很高兴地宣布完成了我们的第十亿临床试验的高剂量队列的招募，并感谢所有参与的患者和研究人员，" Aileron的总裁兼首席执行官Brian Windsor博士表示。"在低剂量队列中观察到的积极趋势后，我们很高兴地评估了每天吸入5毫克LTI-03的安全性、耐受性和生物标志物，并期望在短期内报告头等数据。"
In May 2024, the Company announced positive data from Cohort 1 evaluating low-dose LTI-03 (2.5 mg BID). Following inhaled administration of low-dose LTI-03 in 12 patients, a positive trend was observed in seven out of eight biomarkers with evidence of reduced expression among multiple profibrotic proteins produced by basal-like cells and fibroblasts that contribute to the progression of IPF, including data from three biomarkers that was statistically significant, reinforcing the potential of LTI-03 to improve lung function and reverse the course of IPF.
2024年5月，公司宣布了对低剂量LTI-03（2.5毫克买盘）进行评估的第1队列的积极数据。在12名患者中吸入低剂量LTI-03后，观察到8种生物标志物中有7种呈现积极趋势，表明多种产生由基底细胞和成纤维细胞产生的多种促纤维蛋白蛋白的表达减少的迹象，这些蛋白质有助于IPF的进展，包括三种生物标志物的数据具有统计学意义，强化了LTI-03改善肺功能、扭转IPF病程的潜力。
About the Phase 1 Clinical Trial of LTI-03
关于LTI-03第1期临床试验
The Phase 1b clinical trial of LTI-03 is a randomized, double-blind, placebo controlled, multi-center, dose escalation trial in patients recently diagnosed with IPF that have not received prior treatment with anti-fibrotic agents for at least two months (NCT05954988). Eligible patients are randomly assigned (3:1) to receive one of two doses of inhaled LTI-03 or placebo. The primary objective of the trial is to investigate the safety and tolerability of LTI-03 in patients with IPF after treatment for 14 consecutive days, with measurement of multiple protein biomarkers as exploratory endpoints.
LTI-03的第十亿临床试验是一项随机、双盲、安慰剂对照、多中心、剂量递增试验，针对最近诊断为IPF且至少两个月内没有接受抗纤维化药物治疗的患者进行（NCT05954988）。符合条件的患者将被随机分配（3:1）接受两种剂量的吸入式LTI-03或安慰剂。试验的主要目标是调查IPF患者在连续治疗14天后接受LTI-03后的安全性和耐受性，并测量多种蛋白质生物标志物作为探索性终点。
