(Reuters) - Israel-based RedHill Biopharma Ltd said on Monday its combination antibiotic met the main goal of a late-stage study testing the drug in patients with a type of bacterial infection that affects the stomach and small intestine.
The drug, Talicia, eradicated the Helicobacter pylori infection in 84 percent of patients, compared with 58 percent that received a combination of two commonly used antibiotics.
RedHill estimates 2.5 million patients are treated annually for H. pylori bacterial infections in the United States.
The company said it hopes to file for marketing approval of Talicia with the U.S. Food and Drug Administration in the first half of next year.
Shares of the company were halted before the bell.
Drugmakers have been shying away from developing antibiotics, as combating “superbugs” has become increasingly challenging.
At least 2 million people suffer from antibiotic-resistant infections every year in the United States, according to the Centers for Disease Control and Prevention.
A key component of Talicia is rifabutin, an antibiotic to which H. pylori bacteria have not developed resistance, RedHill said.
Patients who become infected with the bacteria experience abdominal pain, ulcers and an inflammation of the stomach lining. They are also at risk of developing gastric cancer.
Reporting by Tamara Mathias in Bengaluru; Editing by Maju Samuel