- Rein Therapeutics, Inc. (RNTX) has received authorization from the **European Medicines Agency (EMA)** to initiate its **Phase 2 "RENEW" clinical trial** for its lead candidate, **LTI-03**, which is designed to treat **idiopathic pulmonary fibrosis (IPF)**.  **[1420565_0001193125-25-235152_d11439d8k.htm:0]** **[1420565_0001193125-25-235152_d11439dex991.htm:0]** 
- The EMA approval covers clinical trial sites in **Germany and Poland**, building on previous regulatory clearance from the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA).  **[1420565_0001193125-25-235152_d11439dex991.htm:0]** 
- The RENEW trial is a randomized, double-blind, placebo-controlled Phase 2 study that plans to enroll up to **120 patients globally** to assess the safety, tolerability, and efficacy of LTI-03 over a **24-week treatment duration**.  **[1420565_0001193125-25-235152_d11439dex991.htm:0]**

Rein Therapeutics Receives European Regulatory Approval to Initiate Phase 2 Trial of LTI-03

- Rein Therapeutics, Inc. (RNTX) received additional communication from the FDA on **September 16, 2025**, regarding the clinical hold on its U.S. Phase 2 RENEW clinical trial of **LTI-03**.  **[1420565_0001193125-25-210050_d902312d8k.htm:1]** 
- The FDA **agreed that the MCH/H findings in GLP rat studies are not dose-limiting** for the proposed clinical protocol of LTI-03 in idiopathic pulmonary fibrosis (IPF) patients.  **[1420565_0001193125-25-210050_d902312d8k.htm:1]** 
- The FDA recommended the Company prepare a **Complete Response Letter (CRL)** to address safety concerns, explicitly stating that **data from a new GLP toxicity study in rats is not required**.  **[1420565_0001193125-25-210050_d902312d8k.htm:1]** 
- Rein Therapeutics is currently **preparing the CRL** and anticipates submitting it in the coming weeks, with the goal of achieving a timely release of the clinical hold.  **[1420565_0001193125-25-210050_d902312d8k.htm:1]**

Rein Therapeutics (RNTX)