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Also known as Micronized dry powder in hard 2 piece hypromellose capsules
LTI-03 · 2 trials · 2 indications
Incidence of TEAEs by dose
| Arm | Type | Description |
|---|---|---|
| (1) 2.5 mg LTI-03 capsule BID | EXPERIMENTAL | Caveolin-1-Scaffolding-Protein-Derived Peptide |
| (2) 2.5 mg LTI-03 capsules BID | EXPERIMENTAL | Caveolin-1-Scaffolding-Protein-Derived Peptide |
| (1) Placebo capsule BID | PLACEBO_COMPARATOR | Lactose powder |
| (2) Placebo capsules BID | PLACEBO_COMPARATOR | Lactose powder |
| 2.5 mg LTI-03 BID | EXPERIMENTAL | 2.5 mg LTI-03 BID x 14 days |
| 5 mg LTI-03 BID | EXPERIMENTAL | 5 mg LTI-03 BID x 14 days |
| Placebo | PLACEBO_COMPARATOR | Matching placebo BID x 14 days |
| Name | Type | Description |
|---|---|---|
| LTI-03 | DRUG | Caveolin-1-Scaffolding-Protein-Derived Peptide |
| Dry Powder Inhaler | DEVICE | Plastiape Monodose RS01 Model 7 |
| Placebo | DRUG | Lactose powder |
Inclusion Criteria: 1. Male or female age 40 years or older. 2. Willing and able to provide written informed consent. 3. Diagnosis of IPF within 5 years of Screening as confirmed by a centrally read HRCT of the chest as defined by the ATS/ERS/JRS/ALAT guideline. HRCT lung fibrosis by central read d...
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LTI-03 is an investigational small molecule being developed for idiopathic pulmonary fibrosis (IPF), a chronic lung disease. It is in Phase 2 clinical development and has received Orphan Drug and Fast Track designations from the FDA for this indication. LTI-03 has not been approved for any use.
LTI-03 is being developed by Rein Therapeutics, Inc., which trades under the ticker RNTX. The company is sponsoring the clinical program evaluating LTI-03 in idiopathic pulmonary fibrosis, including a Phase 2 study currently recruiting and a completed Phase 1 study.
LTI-03 is in Phase 2 development for idiopathic pulmonary fibrosis. The Phase 2 study, NCT06968845, is currently recruiting participants. An earlier Phase 1 study in newly diagnosed IPF patients has been completed. LTI-03 remains investigational and is not FDA approved.
LTI-03 has been studied in two clinical trials. The completed Phase 1 study, NCT05954988, enrolled 24 patients with newly diagnosed IPF in the United States, Germany, and the United Kingdom. The ongoing Phase 2 study, NCT06968845, is recruiting 120 patients across the United States, Australia, Bulgaria, Germany, Poland, Romania, and the United Kingdom.
The Phase 2 study of LTI-03, NCT06968845, is a randomized, double-blind, placebo-controlled trial enrolling approximately 120 patients with idiopathic pulmonary fibrosis. Participants must be at least 40 years of age, and the study is recruiting across sites in the United States, Australia, Bulgaria, Germany, Poland, Romania, and the United Kingdom.
LTI-03 has received Orphan Drug and Fast Track designations from the FDA for idiopathic pulmonary fibrosis. These designations are intended to support and expedite development of therapies for serious conditions. LTI-03 is a small molecule in Phase 2 development and has not been approved by the FDA.