9 Meters Announces Initiation of Phase 2 VIBRANT Study of Vurolenatide for Short Bowel Syndrome

Initiating the largest Phase 2 placebo-controlled trial in short bowel syndrome

Topline results of the multicenter VIBRANT study anticipated in Q4 2021

RALEIGH, NC / ACCESSWIRE / June 14, 2021 / 9 Meters Biopharma, Inc. (NASDAQ:NMTR), a clinical-stage biotechnology company focused on rare and unmet needs in gastroenterology, announced today the initiation of its Phase 2 trial of vurolenatide, a proprietary long-acting glucagon-like peptide-1 (GLP-1) agonist in adults with short bowel syndrome (SBS).

"Initiating our Phase 2 trial of vurolenatide marks an important milestone for patients and families impacted by the debilitating effects of short bowel syndrome, including chronic diarrhea," said John Temperato, President and Chief Executive Officer of 9 Meters. "This pushes us one step closer to potentially offering patients a treatment option that's long-acting with rapid onset and potentially fewer safety concerns than currently available therapeutics."

The Phase 2 trial, known as the VIBRANT (VurolenatIde for short Bowel syndrome Regardless of pArenteral support requiremeNT) study, is a double-blind, multicenter, placebo-controlled parallel group study of the safety, efficacy and tolerability of vurolenatide in adult patients with short bowel syndrome.

The VIBRANT study is expected to enroll approximately 22 patients at up to 7 sites in the U.S. The trial protocol has achieved central IRB approval and will include 4 parallel treatment arms: vurolenatide 50 mg weekly, vurolenatide 50 mg every other week, vurolenatide 100 mg every other week and placebo. The study is anticipated to be the largest placebo-controlled Phase 2 trial conducted in SBS to date and will enroll patients with any post-surgical SBS anatomic phenotype with or without reliance on parenteral support. The Company continues to collaborate with Duke Clinical Research Institute (DCRI) to support the VIBRANT study as well as the ongoing clinical development of vurolenatide in SBS. Total stool output will serve as the primary endpoint in the study. Topline data is anticipated in the fourth quarter of 2021, with a Phase 3 study expected to be initiated in the same quarter.