European Orphan Drug Designation gives Lung Therapeutics 10 years of market exclusivity in Europe for LTI-01 in the treatment of empyema, a complication of pneumonia.
AUSTIN and TYLER, TX — October 27, 2015 — Lung Therapeutics, Inc., a pharmaceutical company focused on niche, orphan drug indications addressing unmet therapeutic needs in lung injury and disease, announced that the company’s Chief Scientific Officer, Steven Idell, M.D., Ph.D., has received a National Institutes of Health (NIH) grant to develop drug candidate LTI-01 for pleural effusion with loculation. The three-year $1.69 million grant was awarded to UT Health Northeast where Dr. Idell is the Senior Vice President of Medical Research, Dean of the School of Medical Sciences, Temple Chair of Pulmonary Fibrosis and Professor of Medicine.
Austin-based Lung Therapeutics, Inc. was founded by Dr. Idell, who serves as Chief Scientific Officer. Lung Therapeutics is developing lead drug candidate LTI-01 to reduce fibrinous scars in the pleural cavity, which is immediately outside of the lungs, to allow for fluid drainage without surgery for patients with loculated pleural effusion that fails to drain.
“This NIH funding is additional validation of the broad applications of the LTI-01 technology,” said Dr. Idell. “We are excited about receiving the support of the NIH and utilizing their facilities to investigate LTI-01 in the initial clinical trials in which we will test the safety of the approach and obtain some evidence of efficacy.”
Complicated Parapneumonic Pleural Effusions (CPE) and Empyema
Complicated parapneumonic pleural effusions (CPE), a severe consequence of pneumonia, and empyema, pus or bacterial organisms in pleural fluids, are common clinical problems which affect about 80,000 patients in the US and UK annually. These are associated with a mortality of about 20 percent, considerable morbidity and costs of about half a billion dollars annually.
LTI-01 represents a first-in-class therapy for pleural effusion with loculation. The drug is intended to replace costly surgery and ineffective off-label treatments, thus improving clinical outcomes and providing safer and more cost-effective therapeutic options for patients and healthcare providers worldwide. Therapeutic applications of LTI-01 address an ongoing need in a $300+ million global market for patients with non-draining pleural effusions.
Brian Windsor, PhD., Lung Therapeutics CEO, said, “Moving LTI-01 to the clinical trial phase is a significant milestone for our company and demonstrates our commitment to develop safe, effective new medicines for niche populations. We look forward to working closely with clinical trial investigators on this project.”
Utilization of NIH Clinical Center Resources
The safety of intrapleural scuPA (LTI-01) in a phase 1a/1b clinical trial will be conducted at the NIH Clinical Center Facilities in Bethesda, Maryland and at the Medstar Washington Hospital Center in D.C. If successful, the dose escalation trial will inform the field and justify testing in a subsequent phase II efficacy trial that could establish scuPA (LTI-01) as the first FDA-approved, pharmacotherapy for loculated CPE/empyema. The work is supported by a grant from the National Institutes of Health, award number: U01 HL121841-01A1.
About Lung Therapeutics, Inc.
Lung Therapeutics, Inc. is a pharmaceutical company formed to leverage 30 years of leading research in lung injury and disease by pursuing niche, orphan drug indications for which there is no current effective therapeutic option. Current pipeline programs include LTI-01 for Pleural Effusion (PE) with Loculation, LTI-02 for Acute Lung Injury for (ALI) and LTI-03 Idiopathic Pulmonary Fibrosis (IPF). For more information, visit http://www.lungtx.com.
About the NIH, NHLBI and SMARTT Program
LTI-01 developmental work has been supported by the National Institutes of Health (NIH), the National Heart, Lung, and Blood Institute (NHLBI) and the NHLBI Science Moving towArds Research Translation and Therapy (SMARTT) program.
NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases.
The regulatory, biologics, non-biologics, pharmacology and toxicology components of this project have been funded in whole or in part with Federal funds from the National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health and Human Services, under SMARTT Contract Nos. HHSN268201100016C, HHSN268201100014C, HHSN268201100015C, and HHSN268201100017C, respectively.
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