Rein Therapeutics Inc. has announced a pause in enrollment and patient dosing in its Phase 2 RENEW trial for the investigational drug LTI-03 at clinical trial sites in the United States. The pause, instituted on June 10, 2025, follows a clinical hold placed by the U.S. Food and Drug Administration (FDA) as the company works to address non-clinical requests from the agency. Despite the pause in the U.S., the RENEW trial continues to progress with site initiation and patient enrollment in Australia, the United Kingdom, and Europe. LTI-03 is being developed as a treatment for idiopathic pulmonary fibrosis $(IPF.UK)$, and previous Phase 1b clinical trial results indicated positive topline data with no safety signals observed. No drug-related serious adverse events have been reported in any of the studies involving LTI-03 to date.
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