Rein Therapeutics Wins Approval to Launch Phase 2 Clinical Trial of LTI-03 in Idiopathic Pulmonary Fibrosis
Rein Therapeutics recently announced the UK Medicines and Healthcare products Regulatory Agency (MHRA) has authorized the company to initiate its Phase 2 RENEW clinical trial of LTI-03, the company’s lead drug candidate for idiopathic pulmonary fibrosis (IPF).
IPF is a serious, progressive lung disease that affects hundreds of thousands of people worldwide. It scars the lungs, leaving patients short of breath and with limited treatment options. Median survival after diagnosis is just 3-5 years.
Rein’s LTI-03 is a first-in-class therapy that is designed to directly target fibrosis while also protecting the lung’s ability to regenerate healthy tissue. If successful, it could represent a major breakthrough in how pulmonary fibrosis is treated.
Brian Windsor, Chief Executive Officer of Rein Therapeutics, said “This MHRA approval marks an important milestone not only for Rein, but also for patients living with IPF. We are now working towards patient recruitment in the UK, advancing LTI-03 into the next stage of development. Our approach is designed not only to slow disease progression, but also to preserve, and potentially restore, the lung cells that are critical to everyday breathing and quality of life. We believe LTI-03 has the potential to transform outcomes for patients while also creating substantial value for our shareholders.”
The RENEW trial is expected to enroll up to 120 patients worldwide, evaluating two dose groups of LTI-03 against a placebo. The primary objective of the trial is to assess safety and tolerability over 24 weeks of treatment. Secondary endpoints will include measures of lung function and imaging-based assessments of fibrosis progression. Rein is actively working with clinical sites in the UK to begin patient recruitment soon, with initial data expected in 2026.
Rein Therapeutics is a clinical-stage biopharmaceutical company advancing a novel pipeline of first-in-class therapies to address significant unmet medical needs in orphan pulmonary and fibrosis indications. Rein’s lead product candidate, LTI-03, is a novel, synthetic peptide with a dual mechanism targeting alveolar epithelial cell survival as well as inhibition of profibrotic signaling. LTI-03 has received Orphan Drug Designation in the U.S. and is in clinical development. Rein’s second product candidate, LTI-01, is a proenzyme that has completed Phase 1b and Phase 2a clinical trials for the treatment of loculated pleural effusions. LTI-01 has received Orphan Drug Designation in the US and EU and Fast Track Designation in the US.
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