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Aileron Therapeutics Announces Positive Results from First Cohort of Phase 1b Clinical Trial Assessing LTI-03 for Idiopathic Pulmonary Fibrosis (IPF)

Thursday, May 02, 2024

Aileron Therapeutics, Inc. (NASDAQ: ALRN), a biopharmaceutical company focused on developing treatments for orphan pulmonary and fibrosis conditions, has shared encouraging results from Cohort 1 of its Phase 1b clinical trial assessing inhaled LTI-03 in patients with idiopathic pulmonary fibrosis (IPF).

LTI-03, a novel peptide related to Caveolin-1, demonstrated promising outcomes, particularly with a low dose (2.5 mg BID), showing a positive trend in seven out of eight biomarkers. These biomarkers indicated reduced expression of profibrotic proteins linked with basal-like cells and fibroblasts, critical contributors to IPF progression. Notably, three biomarkers exhibited statistically significant reductions, suggesting LTI-03's potential to enhance lung function and potentially reverse IPF's course.

Brian Windsor, Ph.D., President and CEO of Aileron, expressed optimism about the findings, emphasizing the significance of achieving statistical significance in multiple biomarkers. He highlighted the potential for LTI-03 to stabilize or even reverse the disease's progression. The company looks forward to further evaluating LTI-03 in the ongoing study and anticipates sharing results from the high-dose cohort later this year.

Cohort 1 analysis involved twelve patients, with nine in the active arm receiving LTI-03 and three in the placebo arm. Key findings included a decrease in profibrotic proteins, statistically significant reductions in GAL-7, TSLP, and Col-1α1 biomarkers, and the stimulation of solRAGE production, indicative of type I epithelial cell health critical in IPF.

The study demonstrated that LTI-03 was well-tolerated with no serious adverse events reported, and it did not induce inflammation in peripheral blood mononuclear cells (PBMCs).

The Phase 1b trial continues, with top-line results from the high-dose cohort expected in the third quarter of 2024.

Andreas Gunther, M.D., Head of the Center for Interstitial and Rare Lung Diseases at Justus Liebig University, Germany, expressed satisfaction with the Cohort 1 data, affirming LTI-03's mode of action and its potential to address fibroblasts and epithelial cells. He emphasized the promise of LTI-03 in combating IPF's devastating effects and improving lung function and quality of life for patients.

Aileron will host a conference call on May 1st to discuss the initial results from Cohort 1. Interested parties can access the call via dial-in or webcast.

IPF is a progressive lung disease characterized by tissue scarring, predominantly affecting adults aged 65 and older. LTI-03, derived from Caveolin-1, aims to restore the balance of biological signals in the lung to slow down lung function decline and potentially restore healthy lung function.



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