Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LTI-01 · 1 trial · 1 indication
Treatment failure, as evidenced by continued or worsening pleural sepsis and failure to adequately drain pleural effusion, resulting in referral to surgery
| Arm | Type | Description |
|---|---|---|
| 400,000 U LTI-01 | EXPERIMENTAL | 400,000 U LTI-01 once a day (qd) x 3 days administered intrapleurally |
| 800,000 U LTI-01 | EXPERIMENTAL | 800,000 U LTI-01 qd x 3 days administered intrapleurally |
| 1,200,000 U LTI-01 | EXPERIMENTAL | 1,200,000 U LTI-01 qd x 3 days administered intrapleurally |
| Placebo | PLACEBO_COMPARATOR | placebo (normal saline) 6ml qd x 3 days administered intrapleurally |
| Name | Type | Description |
|---|---|---|
| LTI-01 | DRUG | single-chain urokinase plasminogen activator, scuPA |
| Placebo | DRUG | normal saline |
Key Inclusion Criteria: * Male or female ≥ 18 years of age who provide written informed consent * Clinical presentation compatible with complicated parapneumonic pleural effusion (CPE), empyema or other type of pleural infection * Has pleural fluid requiring drainage as determined by chest ultrason...
LTI-01 is an investigational small molecule being developed for the treatment of pleural effusion, specifically infected, non-draining pleural effusions. It is currently in Phase 2 clinical development and has not been approved by the FDA.
LTI-01 is being developed by Rein Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol RNTX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with pleural effusion.
LTI-01 is in Phase 2 clinical development. It has completed one Phase 2 trial and is not yet FDA approved. The drug has received Orphan Drug and Fast Track designations from the FDA for its intended use in pleural effusion.
LTI-01 has been studied in a Phase 2 clinical trial with the identifier NCT04159831, titled 'A Study to Evaluate LTI-01 in Patients With Infected, Non-draining Pleural Effusions.' This randomized, double-blind, placebo-controlled trial enrolled 44 participants in the United States and has been completed.
LTI-01 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for pleural effusion. The FDA has granted it Orphan Drug and Fast Track designations, which are intended to expedite the development and review of drugs for serious conditions.