US biopharmaceutical company Aileron Therapeutics Inc (NASDAQ: ALRN) announced on Wednesday positive topline data from Cohort 2 of its Phase 1b clinical trial assessing 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 modulates both pro-fibrotic activity and sustain 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 clinical trial provide the company with strong confidence that LTI-03 has the potential to improve lung function and reverse the course of IPF.

The ongoing Phase 1b clinical trial enrolled 12 patients, three in the placebo arm and nine in the active arm. Patients had a bronchoscopy at baseline, received a high dose of LTI-03 (5 mg BID) twice a day for 14 days, followed by a bronchoscopy on day 14 and seven days of post-treatment follow-up.