Aileron Therapeutics(ALRN) Prnewswire·2024-11-13 12:00Core Insights - Aileron Therapeutics announced positive topline data from Cohort 2 of its Phase 1b clinical trial for LTI-03, indicating potential therapeutic effects in idiopathic pulmonary fibrosis (IPF) patients [1][2][3] Group 1: Clinical Trial Results - High-dose LTI-03 (5 mg BID) reduced expression of multiple profibrotic proteins in both pathological basal-like cells and fibroblasts, suggesting a therapeutic effect [1][4] - A positive trend was observed in seven out of eight IPF biomarkers, with four biomarkers showing statistically significant changes in the combined data set of Cohort 1 and Cohort 2 [2][4] - Five biomarkers exhibited dose-dependent movement compared to low-dose LTI-03, indicating active pharmacodynamics [1][5] Group 2: Safety and Tolerability - High-dose LTI-03 was well-tolerated, with no safety signals or drug-related adverse events leading to trial discontinuation [1][5] - LTI-03 did not induce inflammation in peripheral blood mononuclear cells, measured by pAKT, a safety marker for inflammation [5] Group 3: Future Plans - The company is planning a Phase 2 clinical trial to further evaluate LTI-03's potential in treating IPF [1][3] - Aileron will host a conference call to discuss the topline results from Cohort 2 of the Phase 1b clinical trial [6] Group 4: Background Information - LTI-03 is a novel, Caveolin-1-related peptide designed to address significant unmet medical needs in orphan pulmonary and fibrosis indications [1][10] - IPF is a chronic lung disease characterized by progressive tissue scarring, affecting approximately 100,000 people in the United States [8]