Aileron Therapeutics to Present Previously Announced Data from the Phase 1b Clinical Trial Evaluating Low-Dose LTI-03 in Idiopathic Pulmonary Fibrosis (IPF) at the 22nd International Colloquium on Lun

First scientific presentation of previously announced data from Cohort 1 of the ongoing Phase 1b clinical trial evaluating low-dose LTI-03 (2.5 mg BID) in IPF, affirms positive trends in seven of the eight biomarkers evaluated, suggesting potential therapeutic effect

Recently completed enrollment of Cohort 2 evaluating high-dose LTI-03 (5 mg BID) in mid-September; topline data expected in the near-term

AUSTIN, Texas, Oct. 12, 2024 /PRNewswire/ — Aileron Therapeutics (NASDAQ:), 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 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…