Rein Therapeutics Doses First Patient in 120-Patient Phase 2 IPF Trial
Rein Therapeutics has dosed the first patient in its Phase 2 trial of inhaled LTI-03 for idiopathic pulmonary fibrosis, enrolling 120 patients across low-dose, high-dose and placebo cohorts in five countries. The randomized, placebo-controlled study will evaluate safety, tolerability and forced vital capacity with interim data expected in late 2026.
1. Phase 2 Trial Launch
Rein Therapeutics has initiated dosing in its Phase 2 clinical trial of LTI-03 for idiopathic pulmonary fibrosis, marking the first patient treated following FDA clearance. This milestone advances the company’s development efforts for a condition with no cure and limited treatment options.
2. Trial Design Details
The study is a randomized, double-blind, placebo-controlled trial with three cohorts: placebo, low dose and high dose. Key assessments include safety, tolerability and changes in forced vital capacity, a critical measure of lung function in IPF patients.
3. Enrollment and Timeline
Approximately 120 patients will be enrolled across clinical sites in five countries. Rein expects to continue enrollment through mid-2027 and plans to report interim data in the second half of 2026 to assess early signals of efficacy.
4. LTI-03 Mechanism of Action
LTI-03 is an inhaled synthetic peptide designed to mimic Caveolin-1 activity, modulating multiple fibrotic pathways and supporting alveolar epithelial progenitor cell health. The therapy aims to preserve lung function by addressing underlying drivers of fibrosis rather than a single pathway.