(Reuters) -Rein Therapeutics has paused patient enrollment and dosing in a mid-stage trial of its lung disease drug in the U.S. after the Food and Drug Administration placed a clinical hold, the drug developer said on Thursday. Shares of the company fell nearly 10% after the bell. The company was testing a drug named LTI-03 […]
Health
US FDA puts on hold Rein Therapeutics’ lung disease drug trial
Audio By Carbonatix
(Reuters) -Rein Therapeutics has paused patient enrollment and dosing in a mid-stage trial of its lung disease drug in the U.S. after the Food and Drug Administration placed a clinical hold, the drug developer said on Thursday.
Shares of the company fell nearly 10% after the bell.
The company was testing a drug named LTI-03 to treat patients with idiopathic pulmonary fibrosis (IPF). The disease causes scarring of the lungs that makes it harder for them to work properly.
Rein said in a filing that it is actively working with the FDA to remove the clinical hold.
The FDA and Rein did not immediately respond to Reuters’ requests for comment on why the hold was placed.
The drug was well-tolerated and safe in an early-stage study in patients with IPF, the company said in the filing. No drug-related serious adverse events have been reported in any studies treating patients with LTI-03, it added.
Rein continues to study the drug and enroll patients in Australia and Europe.
(Reporting by Siddhi Mahatole in Bengaluru; Editing by Sahal Muhammed)