The National Institutes of Health (NIH) will support research conducted by Dr. Steven Idell, MD, PhD, who serves as UT Health Northeast investigator and chief scientific officer of the pharmaceutical company Lung Therapeutics, Inc. The three-year, $1.69 million grant will be used to develop the drug candidate LTI-01 as a first-in-class therapy for pleural effusion with loculation, the company announced in a press release. The condition, which involves an accumulation of pus in the pleural cavity, can develop as a result of pneumonia.
“This NIH funding is additional validation of the broad applications of the LTI-01 technology,” stated Dr. Idell, who founded the Austin, Texas-based company. “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.”
Dr. Idell, who also serves as Senior Vice President of Medical Research, Dean of the School of Medical Sciences, Temple Chair of Pulmonary Fibrosis and Professor of Medicine at UT Health Northeast, is bringing his skills to bear on helping develop Lung Therapeutics’ investigational drug with the goal of addressing therapeutic needs in lung diseases with niche and orphan drug indications.
Lung Therapeutics is working on its lead drug candidate LTI-01 to decrease fibrinous scars in the pleural cavity, which is located directly outside the lungs. By doing so, the drug is expected to enable the drainage of fluid and prevent loculated pleural effusion patients from needing surgery to drain fluid. The NIH grant and resources will be used to test the safety of LTI-01 in a phase 1a/1b clinical trial, which will be conducted at the NIH Clinical Center Facilities in Bethesda, Maryland, and the Medstar Washington Hospital Center in Washington, D.C.
“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,” stated Lung Therapeutics’ CEO, Brian Windsor, PhD. Depending on the success of the phase 1 study, the company may advance to a Phase 2 efficacy trial that may establish the drug as the first FDA-approved pharmacotherapy for loculated complicated parapneumonic pleural effusions (CPE) and empyema.
Complicated parapneumonic pleural effusions are a severe consequence of pneumonia and empyema, and occurs in about 80,000 people every year. The company believes that LTI-01 may improve clinical outcomes and offer safer and more cost-effective alternatives for these patients.
Last year, the U.S. Food and Drug Administration granted an Orphan Drug Designation to LTI-01. The FDA was willing to support the advancement of the injectable indicated for the treatment of located pleural effusion secondary to complications from pneumonia. This FDA designation is selectively given to promising treatments geared toward diseases prevalent in less than 200,000 Americans, and grants the company seven years of marketing exclusivity.