On Wednesday, Aileron Therapeutics Inc ( ALRN ) revealed topline data from Cohort 2 of its Phase 1b trial of safety and tolerability of inhaled LTI-03 for idiopathic pulmonary fibrosis (IPF).

LTI-03 is a novel, Caveolin-1-related peptide that modulates profibrotic activity and sustains critical alveolar epithelial cells.

Following inhaled administration of high dose LTI-03 (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 four biomarkers that were statistically significant in the combined data set of Cohort 1 and Cohort 2, and data from five biomarkers that showed dose dependence relative to the data from those biomarkers in Cohort 1.

Overall, the collective findings from this Phase 1b trial provide the company with strong confidence that LTI-03 has the potential to improve lung function and reverse the course of IPF.

Surfactant protein D (SPD), an indicator of epithelial cell health that is significantly linked to a decline in lung function, decreased by 5% in Cohort 2 at 14 days of treatment, while the current standard of care for IPF reduced SPD by 4% at 12-weeks in precedent trials.

LTI-03 did not induce inflammation in peripheral blood mononuclear cells (PBMCs) in either Cohort, measured by pAKT, a safety marker for inflammation in this trial.

LTI-03 was generally well-tolerated, and there were no drug-related adverse events that resulted in a discontinuation of the trial.

“I am delighted with the Cohort 2 data as it confirms previous results obtained with LTI-03 in cell experiments, animal studies and ex-vivo studies employing human IPF high precision cut lung slices. In these studies, the evaluated biomarkers were found to be downregulated by LTI-03. These observations have now been reproduced in IPF patients upon inhalative application of LTI-03 vs placebo,” said Andreas Gunther, Head of the Center for Interstitial and Rare Lung Diseases of the Justus Liebig University in Germany.

“Moreover, the profile of the statistically significant changes in the biomarkers in response to LTI-03 treatment also suggests that LTI-03 may not only act on fibroblasts, but also on epithelial cells, which would represent a novel therapeutic principle in the IPF treatment landscape.”

Price Action: ALRN stock is trading 5.48% lower at $3.62 at last check Wednesday. During the premarket session, the stock reached at $4.48.

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