Rein Therapeutics announced the that the first patient has been dosed in a Phase 2 study evaluating its LTI-03 caveolin-1 scaffolding domain peptide DPI in patients with idiopathic pulmonary fibrosis, with interim data expected later this year and completion of enrollment expected in mid-2027. The trial is currently recruiting at 5 US locations, with plans to expand to as many as 50, the company says. Earlier this year, the EMA granted orphan drug designation to LTI-03.
Rein announced the initiation of the Phase 2 RENEW trial of LTI-03 in IPF patients in May 2025. Soon after initiation of the study, the FDA placed a clinical hold, which the company announced had been lifted in November 2025. Rein says that the re-start comes after “recent clearance to resume the Phase 2 program and reflects Rein’s successful efforts to address the Agency’s requests and advance the trial.”
Rein Therapeutics CEO Brian Windsor commented, “Dosing the first patient in this Phase 2 trial marks an important step forward for Rein and, more importantly, for patients living with IPF. Current therapies offer limited benefit and often come with significant side effects. Our goal with LTI-03 is to go beyond slowing disease progression and help preserve lung function by addressing the underlying biology of fibrosis. This milestone reflects our team’s focus on execution and brings us closer to understanding the potential impact of LTI-03 for patients.”
Read the Rein Therapeutics press release
