US-based pharmaceutical company Lung Therapeutics has begun enrolment and dosing in a Phase Ia/b clinical trial LTI-01 for the treatment of patients with loculated pleural effusions in Australia and New Zealand (NZ).
LTI-01 is an injectable, fibrinolytic drug that enhances scar removal around the lungs to improve fluid drainage, as well as reduce complications such as bleeding.
The Phase Ia/b trial is being conducted at three sites in each of the country and will evaluate the safety and maximum tolerable dose of LTI-01 in patients who have pneumonia-like symptoms, with a build-up of non-draining fluid around their lungs.
Lung Therapeutics chief executive officer Brian Windsor said: "We are pleased to have dosed the first patient in our Aus / NZ clinical trial with LTI-01.
"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."
LTI-01 was designed to treat empyema and complicated parapneumonic effusions (CPE), which are caused due to pneumonia and involve fibrinous scarring that prevents fluid drainage.
These complications may lead to pus or bacterial organisms in pleural fluids.
LTI-01 has secured orphan drug designation from the US Food & Drug Administration (FDA) in 2014 and from the European Union (EU) in 2015.
Lung Therapeutics primarily develops and commercialises safe and effective drugs for the non-surgical treatment of fibrosis in and around the lungs.
Image: Chest X-ray showing pleural effusion. Photo: courtesy of James Heilman/Wikipedia.