Aileron Therapeutics,  a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, announced the presentation of two abstracts detailing LTI-03's pre-clinical and Phase 1b (NCT05954988) results in Idiopathic Pulmonary Fibrosis (IPF) at the 22^nd International Colloquium on Lung and Airway Fibrosis (ICLAF).

The Company previously announced positive data from Cohort 1 of the ongoing Phase 1b clinical trial evaluating low-dose LTI-03 (2.5 mg BID) in patients with IPF. Following inhaled administration of low-dose LTI-03 in 12 patients over the course of 14 days, a positive trend was observed in seven out of eight biomarkers with evidence of reduced expression among multiple profibrotic proteins produced by basal-like cells and fibroblasts that contribute to the progression of IPF, including data from three biomarkers (collagen synthesis, inflammation, and fibrogenesis) that was statistically significant, reinforcing the potential of LTI-03 to improve lung function and reverse the course of IPF. The [poster][abstracts] being presented at ICLAF will summarize the previously disclosed data from Cohort 1.

Pre-clinical data presented at ICLAF further supports the potential therapeutic effectiveness of LTI-03 for IPF through precision cut lung slices (PCLS) performed ex-vivo. Pre-clinical studies demonstrated molecular activity in IPF PCLS explants indicative of fibrosis during five days in culture and LTI-03 broadly attenuated pro-fibrotic proteins and pathways.

Additionally, the Company recently announced completion of enrollment in Cohort 2 of the ongoing Phase 1b clinical trial evaluating high-dose LTI-03 (5 mg BID) in 12 patients with IPF.  In the trial, eligible patients (n=24) are randomly assigned (3:1) to receive either inhaled LTI-03 or placebo. The primary objective of the trial is to evaluate the safety and tolerability of LTI-03 in patients with IPF after treatment for 14 consecutive days, with measurement of multiple protein biomarkers as exploratory endpoints. The Company expects to report topline data for this cohort in the near-term.