Bekinda was safe, well tolerated, and efficacious for treating acute gastroenteritis and gastritis in the phase 3 GUARD study, the manufacturer announced.
Bekinda (RHB-102; RedHill Biopharma) is an extended-release pill formulation of the antiemetic drug ondansetron, which is taken once daily at a 24-mg dose to relieve nausea and vomiting for 24 hours. Ondansetron is already approved for chemotherapy-induced, radiotherapy-induced and postoperative nausea and vomiting, but if this new formulation is approved, it could become the first 5-HT3 antiemetic drug indicated for acute gastroenteritis and gastritis in the U.S., and the potential annual global market could exceed $650 million, according to a press release.
These positive study results “demonstrate that Bekinda 24 mg is beneficial in the treatment of acute gastroenteritis and gastritis and can provide patients with 24 hours of relief,” Robert A. Silverman, MD, MS, study investigator and emergency medicine specialist at Northwell Health, said in the press release. “Gastroenteritis is a very common illness in the U.S., with approximately 179 million cases annually. If approved by FDA, Bekinda may become the new standard of care helping us treat patients quickly and effectively in both the emergency and outpatient settings.”
In the double blind trial, Silverman and colleagues randomly assigned 321 adults and children older than 12 years to receive 24 mg Bekinda or placebo at 21 sites in the U.S.
Although there was a high positive outcome rate in the placebo group, the study met its primary endpoint with a significantly greater proportion of the intent to treat population experiencing no further vomiting without rescue medication, nor IV hydration between 30 minutes and 24 hours after receiving the drug (65.6% vs. 54.3%; a 21% improvement; P = .04). The difference was greater (65.8% vs. 53.9%; P = .03) after correcting for a randomization error, and in the per-protocol analysis (69.5% vs. 54.9%; a 27% difference; P = .01), according to the press release.
The drug was also safe and well tolerated, and no adverse changes associated with treatment were observed on electrocardiogram.
“Notably, when looking at results by initial severity of nausea, we see a treatment effect even in patients with very severe nausea at baseline, suggesting that the drug works regardless of the initial severity of gastroenteritis,” Terry F. Plasse, MD, RedHill’s medical director, noted in the press release.
RedHill will continue to analyze the data and expects to release a final report in the third quarter of the year. The company also plans to meet with the FDA to the approval pathway, including whether additional clinical studies will be required before filing a New Drug Application.
A phase 2 trial of Bekinda 12 mg for diarrhea-predominant irritable bowel syndrome
is also ongoing, with results expected in September, according to the press release.
Disclosures: Plasse is employed by Redhill Biopharma. Healio Gastroenterology was unable to confirm Silverman’s relevant financial disclosures at the time of publication.