Austin-based Lung Therapeutics, Inc., a pharmaceutical company developing treatments for niche lung diseases, has just announced that the US Food and Drug Administration has granted an Orphan Drug Designation for LTI-01, an injectable indicated for the treatment of located pleural effusion secondary to complications from pneumonia. This FDA designation is selectively given to promising treatments geared towards diseases prevalent in less than 200,000 Americans, and grants the company 7 years of marketing exclusivity.

Loculated pleural effusion, a form of empyema, occurs when pus pools in the pleural space. LTI-01 is a fibronolytic drug that facilitates the removal of lung scarring, lessens bleeding, along with other pulmonary complications in order to promote fluid drainage. The company expects to advance the drug into clinical trials by next year, in 2015.

Pneumonia is a serious lung infection that can lead to death if not treated properly. Of particular risk for life-threatening complications are infants, children, geriatric patients aged 65 years old and older, patients with existing chronic conditions, and the immunocompromised. Aside from loculated pleural effusion or lung abscesses, pneumonia can progress to respiratory failure, sepsis, and acute respiratory distress syndrome. Oftentimes, lung abscesses necessitate surgical drainage, which has its own risks.

Brian Windsor, Ph.D., Lung Therapeutics’ CEO, said the company’s primary focus is to further develop LTI-01 as a non-invasive solution to empyema and other complicated parapneumonic effusions. The company’s founder and CSO, Dr. Steven Idell, added, “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.”

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Lung Therapeutics has also begun work on LTI-02, indicated for acute lung injury, and LTI-03 for IPF.

The respiratory system is one of the most susceptible channels through which a person can acquire an infection, which can lead to pneumonia. Houston-based Pulmotect, Inc. recently completed a Phase I clinical trial of their lead pipeline drug, PUL-042, which has the ability to boost innate lung immune function.