Vurolenatide is safe and efficacious for treating short bowel syndrome (SBS), according to preliminary results from a phase 2 clinical trial.
Vurolenatide is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist intended to slow the transit of food and fluid through the stomach and upper intestine. SBS is a rare disorder associated with loss of small intestinal function and may significantly affect QOL and life expectancy. Patients with SBS present with diarrhea, dehydration, and malnutrition.
The VurolenatIde for short Bowel syndrome Regardless of pArenteral support requiremeNT (VIBRANT) study (ClinicalTrials.gov Identifier: NCT04988997) is a multicenter, double-blind, placebo-controlled parallel group phase 2 trial of vurolenatide for the treatment of adults with SBS. To determine the safety, efficacy, and tolerability of vurolenatide, 11 patients were randomly assigned to 4 treatment arms: 50 mg weekly, 50 mg every other week, 100 mg every other week, or placebo. Investigators sought to identify the dose and dosing interval to inform a planned phase 3 trial. The phase 2 trial remains blinded and is ongoing.
The primary efficacy endpoint was 10% or greater reduction in baseline 24-hour mean total stool output (TSO) during the 6-week double-blind treatment course. The secondary endpoint was a mean decrease in parenteral support volume over the same treatment period.
Seven of the 11 patients met the primary efficacy endpoint. The vurolenatide regimen that will progress to the phase 3 trial was associated with a greater than 25% reduction in TSO.
Among the 5 patients who had a parenteral support requirement at baseline, 3 patients had 20% or greater reduction in parenteral support volume over the 6-week efficacy period.
Vurolenatide was also well tolerated. No patients discontinued therapy due to adverse events. Two serious adverse events of central catheter infections occurred but were unrelated to treatment.
On the basis of these findings, an end-of-phase 2 meeting has been scheduled with the United States Food and Drug Administration (FDA). Full trial results will be released following the meeting with the FDA. The planned phase 3 trial will commence as early as the end of 2022.
Disclosure: This research was supported by 9 Meters Biopharma. Please refer to the original reference for a full list of disclosures.
9 Meters Biopharma announces positive preliminary results from phase 2 study of vurolenatide in short bowel syndrome. News release. Accesswire. June 30, 2022. Accessed July 7, 2022. https://www.accesswire.com/707130/9-Meters-Biopharma-Announces-Positive-Preliminary-Results-from-Phase-2-Study-of-Vurolenatide-in-Short-Bowel-Syndrome