Rein Therapeutics’ LTI-03 Secures the US FDA Fast Track Designation for Idiopathic Pulmonary Fibrosis
Shots:
- The US FDA has granted FTD to LTI-03 for the treatment of idiopathic pulmonary fibrosis
- The P-II (RENEW) trial is a randomized, PBO-controlled study (n=~120) evaluating the safety, tolerability, and efficacy of LTI-03 for idiopathic pulmonary fibrosis across the US, UK, Australia, Poland, and Germany. Patients will receive 1 of 2 LTI-03 doses or PBO. 1EP is safety, measured by the treatment-emergent adverse events through Wk 24 and change in FVC from baseline, on track to report interim data in H2’26
- LTI-03 is an inhaled peptide therapy targeting fibrotic signaling via Caveolin-1 biology, designed to reduce lung scarring while preserving alveolar progenitor cells for tissue repair. It has received FDA ODD for IPF
Ref: Rein Therapeutics | Image: Rein Therapeutics | Press Release
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect@pharmashots.com


