RedHill Biopharma has enrolled the last patient in a Phase 3 clinical evaluating Bekinda (24 mg) for the treatment of acute gastroenteritis and gastritis. The drug, targeting multiple gastrointestinal indications, is also being evaluated in inflammatory bowel syndrome (IBS), according to a company press release.
The randomized, double-blind, placebo-controlled Phase 3 GUARD clinical trial (NCT02246439) is evaluating the safety and effectiveness of Bekinda (ondansetron 24 mg bimodal release tablets) to treat nausea and vomiting from acute gastroenteritis by comparing it to a placebo.
The study, led by Robert A. Silverman, MD, MS, emergency medicine specialist at Hofstra North Shore-LIJ Medical Center and associate professor at the Hofstra North Shore-LIJ School of Medicine in New York, is being conducted at 29 U.S. clinical sites and includes 320 adults and children age 12 and older who suffered from acute gastroenteritis and gastritis.
The primary endpoint is the proportion of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose. Secondary endpoints include frequency of vomiting, severity, and time to resolution of nausea and time to resumption of normal activities.
Bekinda is also being evaluated in a randomized two-arm parallel group Phase 2 clinical trial (NCT02757105) in 120 adult patients with irritable bowel syndrome (IBS). In this study, patients will undergo a two-week observation period during which stool consistency and frequency and symptom data will be collected. Patients will then be randomized to eight weeks of treatment either with Bekinda 12 mg once daily or a placebo. The study is currently recruiting patients at 16 clinical sites in the U.S.
Bekinda is intended to provide patients with relief from nausea and vomiting symptoms for a 24 hours with a single oral tablet.
Considering its latest consultations with the U.S. Food and Drug Administration (FDA), RedHill believes positive results from the GUARD trial may be satisfactory to support potential future marketing applications in the U.S., conditional upon future FDA review and guidance, among other things.
Ondansetron, Bekinda’s active ingredient, is a 5-HT3 (serotonin) receptor antagonist, a class of drugs considered the most effective and significant in preventing nausea and vomiting.