Rein Therapeutics (formerly Aileron Therapeutics) has announced the initiation of the Phase 2 RENEW trial of LTI-03, an inhaled dry powder caveolin-1 scaffolding domain peptide. The company had announced plans for the study in January 2025 and recently said that it had received two new patents covering LTI-03.
The trial is expected to enroll up to 120 patients with idiopathic pulmonary fibrosis and will compare the efficacy of twice-daily 2.5 mg and 5 mg doses of LTI-03 to inhaled placebo over 24 weeks. The company said that it expects to announce topline data from the study in the first half of 2026.
Rein President and CEO Brian Windsor commented, “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. Following productive FDA interactions and positive topline results from the Phase 1b trial, we have designed our RENEW trial to test the promise of our dual mechanism approach to targeting alveolar epithelial cell survival and the inhibition of profibrotic signaling in this patient population. We are pleased to have begun screening patients for RENEW.”
Read the Rein Therapeutics press release
