Rein Therapeutics pauses US enrollment in Phase 2 RENEW trial due to FDA clinical hold

Rein Therapeutics, Inc.

FDA placed clinical hold on Phase 2 RENEW trial of LTI-03 on June 10, 2025; US enrollment and dosing paused.
Rein is working with FDA to address non-clinical requests to resume US enrollment.
Trial continues with site initiation and patient enrollment in Australia, UK, and Europe.
No drug-related serious adverse events reported across all LTI-03 studies.
LTI-03 is a novel Caveolin-1-related peptide for idiopathic pulmonary fibrosis (IPF).

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