Lung Therapeutics, Inc. Doses First Patient in Phase 1 Clinical Trial of LTI-01 in Australia and New Zealand
LTI-01 addresses unmet needs in a $600+ million global market. Intended to replace costly surgery and ineffective off-label treatments of fibrosis, the drug can provide safer and more cost-effective therapeutic options for CPE/empyema patients and healthcare providers worldwide.
Mar 14, 2017, 06:00 ET
AUSTIN, Texas, March 14, 2017 /PRNewswire/ -- Lung Therapeutics, Inc., a clinical stage pharmaceutical company focused on niche, orphan drug indications in lung injury and disease, announced the enrollment today of the first patient in a Phase I a/b clinical trial for LTI-01, designed to treat loculated pleural effusions. The company had previously received clinical trial approval for the company's drug candidate, LTI-01, which is being conducted at three sites each in Australia and New Zealand.
The clinical trial will test 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 has designed LTI-01 to treat empyema and Complicated Parapneumonic Effusions (CPE), two complications of pneumonia that can involve fibrinous scarring that inhibits fluid drainage. These severe complications can result in pus or bacterial organisms in pleural fluids and are common clinical problems which affect patients worldwide, and associated with considerable morbidity and high costs. Lung Therapeutics estimates that more than 100,000 US patients annually could benefit from treatment with LTI-01.
Future Therapeutic Options for Treating Fibrosis
LTI-01 is the first pharmaceutical agent to enter into clinical trials for treating non-draining CPE/empyema. Brian Windsor, PhD, Lung Therapeutics CEO, 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."
An injectable, fibrinolytic drug, LTI-01 maximizes scar removal around the lungs, thereby promoting fluid drainage while minimizing bleeding risk and other complications. Steven Idell, MD, PhD, Lung Therapeutics Founder and Chief Scientific Officer, commented, "By clearing the fibrinous buildup pharmaceutically with LT-01, the clinical pathway for these patients is significantly improved, enabling simple draining of pleural fluid without surgery."
LTI-01 was granted orphan drug designation by the U.S. Food & Drug Administration (FDA) in 2014 and by the EU in 2015. Orphan drug status is given to novel therapeutics treatments that demonstrate value in the treatment of rare diseases or conditions typically affecting fewer than 200,000 patients annually in the U.S. The designation provides Lung Therapeutics with several benefits, including a seven-year period of U.S. marketing exclusivity.
About Lung Therapeutics, Inc.
Headquartered in Austin, Texas, Lung Therapeutics, Inc. is a clinical stage pharmaceutical company formed to leverage 30 years of leading research in lung injury and disease due to fibrosis by pursuing niche, orphan drug indications for which there is no current effective therapeutic option. The company is pioneering the development and commercialization of safe and effective drugs for the non-surgical treatment of fibrosis. Lung Therapeutics is advancing pipeline programs focused on fibrosis in and around the lungs: LTI-03 for Idiopathic Pulmonary Fibrosis and LTI-01 for Pleural Effusion with Loculation. For more information, visit http://www.lungtx.com.
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SOURCE Lung Therapeutics, Inc.