Rein Therapeutics initiates renew phase 2 trial for IPF treatment

Screening begins for study evaluating LTI-03 in idiopathic pulmonary fibrosi

Rein Therapeutics has begun screening and recruiting patients for its renew phase 2 trial, assessing LTI-03 as a potential treatment for idiopathic pulmonary fibrosis (IPF). The study will enrol up to 120 patients across 50 global sites, with topline results expected in the first half of 2026.

LTI-03 is a novel, multi-pathway, Caveolin-1-related peptide designed to improve alveolar epithelial cell survival and inhibit profibrotic signalling. The phase 2 study follows positive findings from a phase 1b trial, where LTI-03 demonstrated dose-dependent effects in five biomarkers, with four achieving statistical significance.

Brian Windsor, president and CEO of Rein Therapeutics, said: “The initiation of the renew trial in patients with IPF marks a significant step forward for Rein as we prepare to ultimately identify and share the potential benefits of LTI-03 on patient lung function.”

The double-blind, placebo-controlled trial will evaluate the safety, tolerability and efficacy of LTI-03 in patients diagnosed with IPF within five years of screening. Participants may continue standard antifibrotic therapy alongside treatment.

Patients will be randomised into two cohorts, receiving either 5 mg/day or 10 mg/day of LTI-03 via inhaled dry powder. The primary endpoint measures treatment-emergent adverse events over 24 weeks, while secondary endpoints assess lung function, biomarker activity and healthy tissue regeneration.

The trial is conducted in collaboration with Qureight Ltd and includes sites in the US, UK, Germany, Austria and Poland.

Rein Therapeutics previously reported encouraging biomarker trends in its phase 1b study, supporting further investigation of LTI-03’s potential impact on lung function in patients with IPF.