Bekinda shows efficacy in IBS-D

Bekinda, an extended-release pill formulation of the antiemetic drug ondansetron, showed efficacy for improving stool consistency in a phase 2 trial of patients with diarrhea-predominant irritable bowel syndrome, RedHill Biopharma announced.

The company said it plans to advance the drug into phase 3 trials, and meet with the FDA by early next year to discuss a path toward approval.

“Bekinda 12 mg demonstrated a very good safety profile in this study as well as impressive efficacy,” June S. Almenoff, MD, PhD, a member of RedHill’s advisory board and former president and chief medical officer of Furiex Pharmaceuticals, said in a press release. “If both the safety and efficacy results are reproduced in the planned pivotal studies, possibly powered to win on pain as well, Bekinda 12 mg has the potential, if approved, to become an important new therapy and standard-of-care for IBS-D.”

Studies have shown that 5-HT3 antagonists like ondansetron, the active ingredient in Bekinda (RHB-102), slow intestinal transit time in humans, according to the press release. Due to potential side effects and lack of benefit experienced with other IBS-D drugs, the company said Bekinda could potentially treat a broader segment of patients if approved.

In the phase 2 double-blind safety and efficacy trial, investigators recruited 126 adults with IBS-D at 16 U.S. centers and randomly assigned them to receive 12 mg Bekinda (n = 75) or placebo (n = 51) once daily for 8 weeks.

The trial met its primary endpoint of stool consistency response as defined by the FDA, which 54.7% of the treatment group achieved vs. 35.3% of the placebo group, for an absolute difference of 19.4% (P = .05).

The company noted these results “compare favorably” with those from two phase 3 studies of Xifaxan (rifaximin, Salix Pharmaceuticals), with an average absolute difference of 10.5%, and two phase 3 studies of Viberzi (eluxadoline, Allergan), with an average absolute difference of 13.5%.

The drug was also safe and well tolerated, with no serious adverse events or unexpected safety issues, according to the press release.

Further, while the study was not powered for statistical significance of secondary efficacy endpoints, the results suggested “clinically meaningful improvement” in both abdominal pain response (an 11.5% absolute difference in overall worst abdominal pain response rate) and overall response (a 15.8% absolute difference in combined stool consistency and abdominal pain response).

These results also “compared favorably” to those from the Xifaxan and Viberzi pivotal studies, the company noted, adding that this comparison “serves as a general benchmark for the effect size observed with Bekinda ... and should not be construed as a direct and/or equal comparison” given the different study designs and patient populations.

The company said it will continue to analyze the study data, which remain subject to completion of independent analysis and the Clinical Study Report, which should be completed in the first quarter of 2018. The company plans to present detailed results at upcoming scientific meetings.

Bekinda has also shown efficacy in acute gastroenteritis and gastritis in the phase 3 GUARD study, the company previously reported. After a positive guidance meeting, the company said it is working with the FDA to design a confirmative phase 3 study to support a New Drug Application for this indication.

Disclosures: Almenoff is employed by RedHill.