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"）（納斯達克股票代碼:ALRN）是一家生物製藥公司，正在推進一系列首創藥物，以應對孤立性肺部和纖維化方面的重大醫療需求。今日宣佈完成進行中針對IPF患者的LTI-03第十億臨床試驗第2隊列的招募。
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.
最後一個患者於9月中旬入組，總共有24名患者參與了試驗。符合條件的患者將被隨機分配（3:1）接受吸入式LTI-03或安慰劑。該試驗的首要目標是評估IPF患者在連續治療14天后接受LTI-03後的安全性和耐受性，並測量多種蛋白質生物標誌物作爲探索性終點。
"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."
"我們很高興地宣佈完成了我們的第十億臨床試驗的高劑量隊列的招募，並感謝所有參與的患者和研究人員，" Aileron的總裁兼首席執行官Brian Windsor博士表示。"在低劑量隊列中觀察到的積極趨勢後，我們很高興地評估了每天吸入5毫克LTI-03的安全性、耐受性和生物標誌物，並期望在短期內報告頭等數據。"
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，公司宣佈了對低劑量LTI-03（2.5毫克買盤）進行評估的第1隊列的積極數據。在12名患者中吸入低劑量LTI-03後，觀察到8種生物標誌物中有7種呈現積極趨勢，表明多種產生由基底細胞和成纖維細胞產生的多種促纖維蛋白蛋白的表達減少的跡象，這些蛋白質有助於IPF的進展，包括三種生物標誌物的數據具有統計學意義，強化了LTI-03改善肺功能、扭轉IPF病程的潛力。
About the Phase 1 Clinical Trial of LTI-03
關於LTI-03第1期臨床試驗
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的第十億臨床試驗是一項隨機、雙盲、安慰劑對照、多中心、劑量遞增試驗，針對最近診斷爲IPF且至少兩個月內沒有接受抗纖維化藥物治療的患者進行（NCT05954988）。符合條件的患者將被隨機分配（3:1）接受兩種劑量的吸入式LTI-03或安慰劑。試驗的主要目標是調查IPF患者在連續治療14天后接受LTI-03後的安全性和耐受性，並測量多種蛋白質生物標誌物作爲探索性終點。
