Lung Therapeutics Receives Orphan Drug Designation for Empyema Treatment

December 2, 2014
BioPharm International Editors

Lung Therapeutics announced that it received Orphan Drug Designation for LTI-01, an injectable designed for the treatment of loculated pleural effusion.

Lung Therapeutics, a pharmaceutical company focusing on orphan drug indications for lung injuries and disease, announced on Dec. 2, 2014 that it received Orphan Drug Designation for LTI-01, an injectable designed for the treatment of loculated pleural effusion caused by complications from pneumonia. FDA grants Orphan Drug Designation to novel drugs that demonstrate value in the treatment of diseases or conditions affecting less than 200,000 individuals in the US and includes a seven-year period of marketing exclusivity.

“Our initial focus is on LTI-01, which is designed to treat empyema and complicated parapneumonic effusions, two complications of pneumonia that can involve fibrinous scarring that inhibits fluid drainage,” said Brian Windsor, PhD, CEO of Lung Therapeutics, in a press release.

LTI-01 is an injectable, fibronolytic drug that promotes healthy fluid drainage by increasing scar removal around the lungs while lessening bleeding and other complications. Loculated pleural effusion is a type of empyema, which is characterized by a collection of pus in the pleural space between the lung and inner surface of the chest wall. Lung Therapeutics expects to move LTI-01 into clinical trials in 2015, according to the press release.

“LTI-01 could improve outcomes for thousands of patients a year who become seriously ill with pleural effusions that are difficult to drain, and increasing incidence demands more effective therapy. We believe that LTI-01 will enable patients to avoid surgical treatment and its associated morbidity and cost,” said Steven Idell, MD, PhD, Lung Therapeutics’ founder and chief scientific officer, in a press release.

Lung Therapeutics is also developing LTI-02 for the treatment of acute lung injury and LTI-03 for idiopathic pulmonary fibrosis (IPF). In October 2014, FDA approved the first two IPF treatments, Esbriet (pirfenidone) and OFEV (nintedanib).

Source: Lung Therapeutics