- 9 Meters Biopharma Inc NMTR announced the final results from the Phase 2 VIBRANT study of vurolenatide in short bowel syndrome (SBS) and the outcome of its End-of-Phase 2 meeting with the FDA.
- 9 Meters will finalize the Phase 3 protocol in collaboration with the FDA during Q4.
- Vurolenatide 50 mg every two weeks dosing arm demonstrated a 30% reduction in total stool output (TSO), compared with a 32% increase for placebo, equivalent to a mean relative reduction of 62%.
- In patients treated with 50 mg vurolenatide every week, there was a mean TSO decrease of 8% vs. 40%.
- In patients treated with 100 mg vurolenatide every two weeks, there was mean a TSO increase of 16% vs. 16% in placebo.
- Five of the 11 patients in the study were receiving parenteral support. There was a mean decrease of 17% in the parenteral support volume of these five patients by week two, which was sustained throughout the 6-week observation period.
- Two of the five patients remained stable, and three demonstrated a mean decrease in PS of 28%.
- Vurolenatide was generally well tolerated with mild to moderate and transient side effects, the most common of which were nausea and vomiting.
- Price Action: NMTR shares are up 19.57% at $0.2475 during the premarket session on the last check Tuesday.
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