RNTX

FDA Lifts Clinical Hold: Rein Therapeutics announced that the FDA has lifted the full clinical hold on its phase 2 trial for LTI-03, allowing the study to proceed after addressing the agency's concerns.

CEO's Statement: Brian Windsor, CEO of Rein Therapeutics, highlighted the FDA's decision as a significant milestone, enabling the company to resume patient enrollment and advance the treatment for idiopathic pulmonary fibrosis (IPF).

Patient Recruitment Timeline: Rein plans to resume patient recruitment in late 2025 or early 2026 at around 20 clinical sites across the U.S., complementing its global RENEW study with additional sites in the UK, Germany, Poland, and Australia.

Trial Objectives: The trial aims to evaluate the safety, tolerability, and efficacy of LTI-03 in up to 120 patients with IPF, focusing on its potential to slow fibrosis and support lung repair.

FDA Approval: The FDA has lifted the clinical hold on Rein Therapeutics' Phase 2 trial for LTI-03, allowing the company to resume U.S. patient enrollment expected in late 2025 or early 2026 across 20 clinical sites.

LTI-03 Potential: Early data indicates that LTI-03 may not only slow fibrosis in idiopathic pulmonary fibrosis (IPF) patients but also promote lung healing, representing a dual-action approach to treatment.

Global Study Expansion: The U.S. enrollment will complement a broader global study that includes approximately 30 additional sites in the UK, Germany, Poland, and Australia, aiming to evaluate the safety and efficacy of LTI-03 in up to 120 patients.

Market Need: IPF is a progressive lung disease with limited treatment options, highlighting the urgent need for new therapies, as the global market for fibrosis treatments is projected to exceed $11 billion by 2031.