Rein Therapeutics, Inc. (NASDAQ: RNTX) announced today that the European Medicines Agency (EMA) has granted approval to initiate its Phase 2 RENEW clinical trial of the company’s lead candidate, LTI‑03, for idiopathic pulmonary fibrosis (IPF). The approval covers clinical trial sites in Germany and Poland, adding two key European centers to the global study.
The RENEW trial is a randomized, double‑blind, placebo‑controlled Phase 2 study designed to enroll up to 120 IPF patients over a 24‑week treatment period across two dosing groups. With the EMA clearance, the trial can now begin patient enrollment in Germany and Poland, complementing the earlier UK approval received from the Medicines and Healthcare products Regulatory Agency (MHRA).
This regulatory milestone expands the geographic footprint of the RENEW study, potentially accelerating patient recruitment and providing a broader data set for the company’s pivotal program. The addition of European sites strengthens the trial’s global relevance and positions Rein Therapeutics to advance LTI‑03 toward regulatory submissions in multiple markets, a critical step for future commercialization and investor confidence.
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