9 Meters says Vibrant study shows 30% reduction in primary endpoint

9 Meters announced final results of its Phase 2 trial known as VIBRANT ,VurolenatIde for short Bowel syndrome Regardless of pArenteral support requiremeNT,evaluating the safety, efficacy, and tolerability of vurolenatide in adult patients with SBS.Over the six-week observation period, 50 mg of vurolenatide dosed every two weeks demonstrated a 30% reduction in the primary endpoint, mean reduction in total stool output compared with a 32% increase for placebo – for a mean relative reduction of 62%. Based on these results, together with the most favorable adverse event and optimal pharmacokinetic profile, the Company plans to move this dose regimen forward into a pivotal clinical development program.We also evaluated the change from baseline in parenteral support volume as an important secondary endpoint. Five patients were receiving parenteral support at study entry. They experienced a mean decrease of 17% in the parenteral support volume by week two. This effect was sustained throughout the six-week observation period, with two patients remaining stable and three experiencing a mean decrease in PS of 28%.Vurolenatide was generally well tolerated with mild to moderate and transient side effects. John Temperato, President & Chief Executive Officer of 9 Meters Biopharma, commented: "The successful completion of the VIBRANT study was a key milestone in our efforts to progress vurolenatide for SBS. Vurolenatide is the first GLP-1 agonist being developed specifically for SBS and directly addresses the malabsorption of nutrients and fluids by replacing missing GLP-1. The unique mechanism of action, as observed in the VIBRANT study, resulted in a decrease in both total stool output and parenteral support volume with a rapid onset of action, sustained response, and an every two-week dosing regimen. Furthermore, unlike the GLP-2 class, which is only applicable to patients on parenteral support, vurolenatide is being developed to address all SBS patients including the nearly 50% of patients not on parenteral support, for which there are no current treatment options. We look forward to finalizing protocol details in the fourth quarter and plan to initiate the Phase 3 program shortly thereafter."