Rein Therapeutics announced that the FDA has lifted a full clinical hold on the Phase 2 “RENEW” trial of the company’s LTI-03 inhaled dry powder caveolin-1-based peptide in patients with idiopathic pulmonary fibrosis (IPF). The company initiated the trial in May 2025, and a July 2025 press release related to new financing agreements notes the existence of a hold.
According to the company, US recruitment is expected to resume by early 2026. The trial is also expected to enroll IPF patients in the UK and in Europe.
Rein CEO Brian Windsor commented, “This is a major milestone for us. The FDA’s decision clears the path for us to resume enrollment and continue advancing LTI-03 through our global Phase 2 program. We’re grateful for the FDA’s collaboration and proud of our team for their hard work and dedication to getting to this point. We believe LTI-03 has the potential to meaningfully shift how IPF is treated by not only slowing fibrosis but also supporting lung repair.”
Read the Rein Therapeutics press release
