FDA lifted the full clinical hold on Rein Therapeutics’ Phase 2 RENEW trial of LTI‑03, a first‑in‑class inhaled peptide therapy for idiopathic pulmonary fibrosis.
The hold, in effect since June 10, was removed after the agency reviewed the company’s submission addressing its concerns. The RENEW trial (Study LTI‑03‑2001) is a randomized, double‑blind, placebo‑controlled Phase 2 study enrolling up to 120 patients across roughly 20 U.S. sites, with additional sites outside the U.S. The trial aims to evaluate safety, tolerability, and efficacy, with topline data expected in Q3 2026.
LTI‑03 targets lung scarring by inhibiting fibrosis while preserving alveolar progenitor cells, offering a dual mechanism distinct from current therapies such as nintedanib. Early data from ex vivo lung slices show suppression of collagen and pro‑inflammatory cytokines without inducing necrosis or apoptosis. The lift of the hold reduces a key regulatory risk and positions Rein closer to potential approval, while the company remains a clinical‑stage biopharma with no revenue and no debt.
Rein expects to resume patient recruitment in late 2025 or early 2026, and the company has received Orphan Drug Designation in the U.S. and regulatory approvals to initiate the trial in the U.K. and Europe.
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