Rein Therapeutics Gets FDA Clearance To Resume Phase 2 Trial Evaluating LTI-03 In Patients With IPF

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(RTTNews) - Biopharmaceutical company Rein Therapeutics (RNTX), Monday announced that the U.S. Food and Drug Administration has lifted the full clinical hold on the company's phase 2 trial evaluating LTI-03 in patients with idiopathic pulmonary fibrosis (IPF).

The FDA's decision follows a review of Rein's submission, which addressed all of the agency's concerns. In its correspondence, the FDA confirmed that Study LTI-03-2001 may proceed and that any prior Full Clinical Hold concerns have been fully resolved.

Brian Windsor, Ph.D., Chief Executive Officer of Rein Therapeutics, 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."

Rein expects to resume patient recruitment in late 2025 or early 2026 across approximately 20 U.S. clinical sites located in Alabama, California, Colorado, Connecticut, Florida, Indiana, Kansas, Massachusetts, Michigan, Missouri, North Carolina, New York, Ohio, South Carolina, and Texas.

The U.S. enrollment complements Rein's broader global RENEW study, which includes approximately 30 additional sites in the United Kingdom, Germany, Poland, and Australia. The trial is designed to evaluate the safety, tolerability, and efficacy of LTI-03 in up to 120 patients with IPF.