Lung Therapeutics has enrolled its first patient in a Phase 1 a/b clinical trial assessing LTI-01, a drug designed to treat pleural effusions, a severe complication of pneumonia.
The study, taking place at three sites each in Australia and New Zealand, will evaluate the safety and maximum tolerable dose of LTI-01 in patients who have pneumonia-like symptoms with a buildup of non-draining fluid around their lungs.
Pleural effusion doesn’t begin as a life-threatening illness but may arise as a severe complication of pneumonia, which is characterized by fluid in the lungs due to an infection, and is usually treatable with antibiotics. Sometimes, however, in severe cases, fluid begins to build up in the pleural cavity between the lungs and the lung lining, resulting in pleural effusion.
LTI-01 is a pro-enzyme that slowly becomes activated in the pleural space. Lung Therapeutics says its drug is effective in clearing scar tissue with once-a-day dosing for one to three days, and promotes fluid drainage around the lungs without any significant bleeding.
LTI-01 was developed as a treatment for empyema and complicated parapneumonic effusions (CPE) — two complications of pneumonia that can involve fibrinous scarring, which inhibits fluid drainage and results in considerable morbidity and high costs.
Lung Therapeutics, based in Austin, Texas, says LTI-01 — the first drug entering into clinical trials for treating non-draining CPE and empyema — could benefit more than 100,000 U.S. patients yearly.
“We are pleased to have dosed the first patient in our Aus/NZ clinical trial with LTI-01,” said the company’s CEO, Brian Windsor, PhD, in a press release. “It is an exciting step forward in obtaining valuable safety and dosing data that will enable us to help CPE and empyema patients around the world. We are committed to giving these underserved patients better therapeutic options that are safer, simpler and less costly.”
Added Steven Idell, MD, PhD, the company’s founder and chief scientific officer: “By clearing the fibrinous buildup pharmaceutically with LTI-01, the clinical pathway for these patients is significantly improved, enabling simple draining of pleural fluid without surgery.”
LTI-01 won orphan drug designation by the U.S. Food & Drug Administration in December 2014, and by the European Commission in January 2015.
