RedHill Biopharma has initiated a Phase III clinical trial of RHB-102, an oral, extended-release, once-daily formulation of the antiemetic drug ondansetron, to treat patients suffering from acute gastroenteritis.
Ondansetron is a 5-HT3 antagonist and the active pharmaceutical ingredient in RHB-102.
The trial is designed to evaluate the safety and efficacy of RHB-102 in patients with gastroenteritis, which is an inflammation of the gastrointestinal tract that causes, among other symptoms, nausea and vomiting.
Approximately 320 adults and children over 12 years of age who suffer from acute gastroenteritis will be enrolled in RHB-102 GUARD study, which will be conducted in up to ten clinical sites in the US.
In the randomised, double-blind, placebo-controlled, parallel group Phase III trial, patients will be given either RHB-102 or a placebo.
The primary endpoint of the trial is the absence of vomiting from 30 minutes after the first dose through the discharge from the emergency department, while secondary endpoints include frequency of vomiting, severity and time to resolution of nausea, and time to resumption of normal activities.
The company intends to report top-line results from the RHB-102 Phase III trial in the second half of 2015.
After discussions with the FDA and the UK Medicines and Healthcare Products Regulatory Agency (MHRA), the GUARD trial is intended to support potential future submissions of marketing applications in both the US and Europe for this indication.
If approved by the FDA, RHB-102 could become the first-ever 5-HT3 antiemetic drug indicated to treat acute gastroenteritis.
RedHill Research and Development senior vice-president Dr Reza Fathi said: "It is the third GI-focused Phase III study that RedHill is currently conducting in the US, along with the RHB-104 MAP US study for Crohn's disease and the RHB-105 ERADICATE Hp study for H pylori infection."
Separately, the company is pursuing marketing approval of RHB-102 for the indications of chemotherapy-induced and radiotherapy-induced nausea and vomiting (CINV and RINV respectively) in the US and Europe.