Patients with recently diagnosed with idiopathic pulmonary fibrosis are part of the trial. Credit: Pheelings media / Shutterstock.

Aileron Therapeutics has reported positive outcomes from cohort one of the ongoing Phase Ib clinical trial of inhaled LTI-03 in patients with idiopathic pulmonary fibrosis (IPF).

The randomised, double-blind, placebo-controlled, multicentre dose-escalation study involves patients who were recently diagnosed with IPF and who have not been treated with anti-fibrotic agents for a minimum of two months.

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Trial subjects are randomised into a 3:1 ratio to receive one of two doses of LTI-03 or placebo.

The primary goal of the study is to assess the safety and tolerability of LTI-03 after a 14-day treatment period.

Multiple biomarker concentrations are evaluated as exploratory endpoints.

A Caveolin-1-related peptide, LTI-03 is designed to hinder pro-fibrotic signalling while preserving essential epithelial cells.

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The trial data revealed that a low dose of inhaled LTI-03 (2.5mg BID) demonstrated a favourable trend in seven out of eight biomarkers.

These biomarkers are associated with the reduced expression of pro-fibrotic proteins produced by basal-like cells and fibroblasts, which are known to contribute to the progression of IPF.

Furthermore, several biomarkers showed statistically significant data.

The administration of LTI-03 did not trigger inflammation in peripheral blood mononuclear cells (PBMCs).

The results also indicated that LTI-03 is well-tolerated without any serious adverse events reported.

The Phase Ib study is progressing, with top-line data from the high-dose cohort anticipated in the third quarter of this year.

Aileron president and CEO Brian Windsor said, “We find it encouraging that low-dose LTI-03 achieved statistical significance in three out of eight biomarkers evaluated in the trial.

“This, paired with the positive trends observed in several of the other biomarkers, strengthens our belief that LTI-03 has the potential for disease stabilisation or even reversal. We look forward to continuing to evaluate LTI-03 in the ongoing Phase Ib study and sharing results from the high-dose cohort later this year.”