eClinical Technology and Industy News

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

Low-dose LTI-03 (2.5 mg BID), a Caveolin-1 related peptide, reduced expression of multiple profibrotic proteins in both pathological basal-like cells and fibroblasts and increased the expression of a biomarker indicative of epithelial health, suggesting potential therapeutic effect

Positive trend was observed in seven of eight IPF biomarkers evaluated

Low-dose LTI-03 was well-tolerated, with no safety signal observed

Data from Cohort 2 evaluating high-dose LTI-03 (5 mg BID) is expected in the third quarter of 2024

Excerpt from the Press Release:

WALTHAM, Mass., May 01, 2024 (GLOBE NEWSWIRE) — 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 positive data from Cohort 1 of the ongoing Phase 1b clinical trial evaluating the safety and tolerability of inhaled LTI-03 in patients diagnosed with idiopathic pulmonary fibrosis (IPF). LTI-03 is a novel, Caveolin-1-related peptide that addresses both inhibition of pro-fibrotic signaling and survival of critical epithelial cells.

Following inhaled administration of low dose LTI-03 (2.5 mg BID), a positive trend was observed in seven out of eight biomarkers with evidence of reduced expression among profibrotic proteins produced by basal-like cells and fibroblasts that contribute to the progression of IPF, including data from several biomarkers that were statistically significant, reinforcing the potential of LTI-03 to improve lung function and reverse the course of IPF.

“We find it encouraging that low dose LTI-03 achieved statistical significance in three out of eight biomarkers evaluated in the trial” said Brian Windsor, Ph.D., President and Chief Executive Officer of Aileron.

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