Israeli biopharmaceutical firm RedHill Biopharma Ltd. said on Monday that its drug to treat a bacterial infection that can cause ulcers and gastric cancer has been found to be safe and effective in a late-stage study.
The firm said that its Talicia drug to treat H. pylori infection “met its primary endpoint with a high degree of statistical significance,” eradicating the infection in 84 percent of patients, compared to a 54% success rate with patients who received a combination of two commonly used antibiotics.
“No safety issues were reported in the study and Talicia was found to be well tolerated,” the statement said.
The shares of the company were trading 8.4% higher on the Nasdaq at 10:32 a.m. in New York.
H. pylori is a bacterial infection proven to be a major cause of ulcers and a major contributor to gastroenteritis, gastric cancer, and other stomach-related maladies.
The US Food and Drug Administration has listed H. pylori as a high priority bacteria for development of new drugs and in 2017 the World Health Organization included it in its list of bacteria for which new and effective antibiotic treatments were needed.
Dror Ben-Asher, RedHill’s CEO, said the results were “excellent” and that the firm hopes to start the US commercial launch of the drug “in the in the second half of 2019, subject to FDA approval.”
A commercial launch of Talicia, a fixed-dose, all-in-one oral capsule that combines two antibiotics, rifabutin and amoxicillin, and a proton pump inhibitor (PPI), omeprazole, would make it the first new drug launched for the treatment of H. pylori infection in many years, Shani Maurice, VP of business development and communications, said in an email message to The Times of Israel.
H. pylori bacterial infection affects over 50% of the adult population worldwide and 30%-40% of the US population, with an estimated 2.5 million patients treated annually in the US. The bacterial infection is the strongest risk factor for the development of gastric cancer and a major risk factor for development of peptic ulcer disease.
However, the efficacy of the antibiotics commonly used to treat patients with the infection is declining, due to the high resistance the bacteria has developed to these medications.
“The resulting high failure rates of standard-of-care treatments, estimated at 30-40%, are a major public concern among the medical community worldwide and underscore the urgent need for new H. pylori eradication therapies,” said Professor David Graham, the lead investigator of the study.
RedHill was founded by Dror Ben-Asher and Ori Shilo, two kibbutz dwellers turned investment bankers and now entrepreneurs.