Israeli biotech firm Redhill Biopharma Ltd. said Wednesday that a drug it is developing for the treatment of acute gastroenteritis met its efficacy target and was found to be safe and well-tolerated.
A randomized, double-blind, placebo-controlled Phase III GUARD study evaluated the efficacy and safety of 24 milligrams of BEKINDA in treating acute gastroenteritis and gastritis. Three hundred and twenty-one adults and children over the age of 12 were enrolled at 21 clinical sites in the US.
The positive results of the study demonstrate that BEKINDA “is beneficial in the treatment of acute gastroenteritis and gastritis and can provide patients with 24 hours of relief,” said Dr, Robert Silverman, a specialist in emergency medicine specialist at Northwell Health and the lead investigator of the BEKINDA study.
Gastroenteritis is a very common illness in the US, with approximately 179 million cases annually, he said. If approved by the US Food and Drug Administration (FDA), BEKINDA “may become the new standard of care helping us treat patients quickly and effectively in both the emergency and outpatient settings.”
Redhill’s medical director Dr. Terry Plasse said the company would present the data to the FDA to discuss the path for the marketing approval of the drug in the US.
Redhill, which is traded both in Tel Aviv and on the Nasdaq, was founded by Dror Ben-Asher and Ori Shilo, two former kibbutz dwellers. The company tackles debilitative gastrointestinal diseases, including ulcers and Crohn’s disease, by tackling bacteria they believe to be at the root of the ailments.
Redhill’s shares were trading 8.2 percent higher at 3:30 p.m. in Tel Aviv.