Aileron Therapeutics Announces Positive Data from Cohort 1 of the Phase 1b Clinical Trial of LTI-03 in Idiopathic Pulmonary Fibrosis (IPF) - Seite 2

• Reduced expression of multiple profibrotic proteins in both pathologic basal-like cells and fibroblasts, with statistically significant decreases observed in GAL-7, TSLP and Col-1α1 biomarkers, supporting the potential of LTI-03 to reduce fibrosis, inflammation and associated changes in the lung.
• Stimulated production of solRAGE, a factor indicative of type I epithelial cell health that is a critically important aspect of IPF and has gone largely unaddressed.
• LTI-03 did not induce inflammation in peripheral blood mononuclear cells (PBMCs).
• Results show LTI-03 to be generally well-tolerated with no serious adverse events (SAEs) reported.

The Phase 1b study is ongoing, with topline results from the high-dose cohort expected in the third quarter of 2024.

“We are pleased with the Cohort 1 data as it seems to confirm LTI-03’s mode of action in patients with IPF” said Andreas Gunther, M.D., Head of the Center for Interstitial and Rare Lung Diseases of the Justus Liebig University in Giessen, Germany. “Importantly, the statistical significance observed in collagen deposition, inflammation and cellular processes underscores the potential of LTI-03 to act on both, fibroblasts as well as epithelial cells, the latter of which are believed to be causative in onset and aggravation of the disease. These findings underscore the promise of LTI-03 to combat the devastating effects of IPF and improve lung function and quality of life for those living with the disease. I look forward to further evaluating LTI-03’s potential, particularly at the higher dose, in the ongoing study.”

Conference Call Information

Aileron will host a conference call on Wednesday, May 1st at 9:00am ET to discuss the initial results from Cohort 1 of the Phase 1b clinical trial of LTI-03 in IPF. To access the call, please dial [phone] (domestic) or [phone] (international) and reference meeting ID: 970 4548 0706 when prompted by the operator. A live webcast of the event can be accessed at https://investors.aileronrx.com/events-presentations/investor-events. A replay of the webcast will be available following the completion of the event.

About the Phase 1 Clinical Trial of LTI-03

The Phase 1b clinical trial of LTI-03 is a randomized, double-blind, placebo controlled, multi-center, dose escalation study 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 LTI-03 or placebo. The primary objective of the study is to investigate the safety and tolerability of LTI-03 in patients with IPF after treatment for 14 consecutive days, with multiple biomarker concentration as exploratory endpoints.