UK approves Phase 2 trial for IPF therapy candidate LTI-03
Rein Therapeutics working with clinical sites to begin enrolling patients
Rein Therapeutics is working with clinical sites to begin recruiting patients in the U.K. for its Phase 2 trial of LTI-03, a therapy candidate for idiopathic pulmonary fibrosis (IPF), after receiving approval from the country’s Medicines and Healthcare Products Regulatory Agency (MHRA).
“This MHRA approval marks an important milestone not only for Rein, but also for patients living with IPF,” Brian Windsor, Rein’s CEO, said in a company press release. “We are now working [toward] patient recruitment in the U.K., advancing LTI-03 into the next stage of development.”
This furthers the company’s plans for the RENEW trial (NCT06968845), which recently began U.S. recruitment. Ultimately, Rein expects up to 120 people to participate in the trial at sites worldwide.
Earlier LTI-03 trial showed decreases in molecular markers of fibrosis
In IPF, progressive scarring, or fibrosis, occurs in the lungs due to unknown causes. The chronic lung disease results in respiratory symptoms including cough, difficulty breathing, and fatigue.
People with IPF have low levels of a protein called caveolin-1 (Cav1), which helps prevent fibrosis, in their lungs. With LTI-03, Rein aims to deliver a part of this protein to increase these levels.
The inhaled therapy may also help preserve the alveolar epithelial cells that line the air sacs in the lungs. These cells are critical in the process of moving oxygen into the bloodstream while removing carbon dioxide.
Results from a Phase 1b trial (NCT05954988) showed decreases in several molecular markers of fibrosis after two weeks of twice-daily dosing. There were also increases in a marker of alveolar epithelial cell health.
“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,” Windsor said.
The RENEW trial will investigate the therapy over 24 weeks, or about six months. Each participant will receive either a low or high dose of LTI-03 (2.5 mg or 5 mg) or a placebo to inhale twice per day. Rein plans to assess the medication’s safety and tolerability. Secondary outcomes include changes in metrics of lung function and fibrosis.
We believe LTI-03 has the potential to transform outcomes for patients while also creating substantial value for our shareholders.
RENEW will include IPF patients who are 40 and older. Individuals prescribed certain standard IPF therapies, including Ofev (nintedanib) or pirfenidone (marketed as Esbriet, with generics available), must be on a stable dose for at least 12 weeks before receiving a group assignment.
Following MHRA approval, Rein is working with clinical sites in the U.K. in the hopes of beginning local patient recruitment soon. Initial trial data is expected in 2026.
“We believe LTI-03 has the potential to transform outcomes for patients while also creating substantial value for our shareholders,” Windsor said.
LTI-03 was first developed by a team at University of Texas at Tyler that is working on peptide-based therapy for radiation-induced pulmonary fibrosis.
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