AUSTIN, Texas – Aileron Therapeutics announced the presentation of data from its Phase 1b clinical trial of LTI-03 in patients with Idiopathic Pulmonary Fibrosis (IPF) at the 22nd International Colloquium on Lung and Airway Fibrosis (ICLAF). The data highlights the potential of LTI-03 to improve lung function and reverse the course of IPF.
Phase 1b Trial Results
The Phase 1b trial (NCT05954988) evaluated low-dose LTI-03 (2.5 mg BID) in 12 IPF patients. After 14 days of inhaled administration, a positive trend was observed in seven out of eight biomarkers. Notably, statistically significant reductions were seen in biomarkers related to collagen synthesis, inflammation, and fibrogenesis. These findings suggest LTI-03's potential to mitigate IPF progression by targeting basal-like cells and fibroblasts.
Pre-clinical Evidence
Pre-clinical data presented at ICLAF further supports LTI-03's therapeutic effectiveness. Ex-vivo studies using precision cut lung slices (PCLS) from IPF patients demonstrated that LTI-03 attenuated pro-fibrotic proteins and pathways, indicating its potential to modify the disease at a molecular level.
Ongoing Clinical Development
Aileron Therapeutics has completed enrollment in Cohort 2 of the Phase 1b trial, evaluating a higher dose of LTI-03 (5 mg BID) in 12 IPF patients. The trial is a randomized, double-blind, placebo-controlled study where eligible patients (n=24) are randomly assigned (3:1) to receive either inhaled LTI-03 or placebo. The primary objective is to assess the safety and tolerability of LTI-03 over 14 days, with protein biomarker measurements serving as exploratory endpoints. Topline data from Cohort 2 is expected in the near term.
About Idiopathic Pulmonary Fibrosis (IPF)
IPF is a chronic, progressive lung disease characterized by tissue scarring, affecting approximately 100,000 people in the United States. It typically manifests in adults aged 65 or older and is often fatal within two to five years of diagnosis. Current treatments aim to slow disease progression, but there remains a significant unmet need for therapies that can reverse or halt the disease.
LTI-03 and Caveolin-1 (Cav1) Mechanism
LTI-03 is a seven amino acid peptide derived from the caveolin scaffolding domain (CSD) of the Cav1 protein. Cav1 plays a crucial role in preventing fibrosis by balancing pathways involved in lung repair and cell movement. In IPF, Cav1 expression is decreased, disrupting this balance. LTI-03 aims to restore this balance, potentially slowing lung function decline and promoting healthy lung function by protecting epithelial cells.
