Vurolenatide is designed specifically to slow digestive transit, thereby mitigating the SBS hallmark of excessive gastric motility due to deficient GLP-1 in the shortened intestine. This mechanism is intended to improve intestinal absorption of nutrients and water and reduce diarrhea for all patients with any type of post-surgical SBS, regardless of their parenteral support requirements. Owing to its extended half-life, vurolenatide only needs to be dosed twice monthly at most, thus considerably improving convenience for patients and their caregivers.
9 Meters initiated VIBRANT, the largest placebo-controlled Phase 2 trial in SBS in an ambulatory setting, in Q2 2021, which includes patients with all post-surgical types of SBS regardless of their parenteral support requirements. An FDA meeting communication supported utilizing total stool output (TSO) as the trial’s primary efficacy outcome measure. A Phase 3 trial is expected to begin by the end of 2021.
Previously, the company announced positive topline data from an open-label, 2-dose Phase 1b/2a data in adults with SBS evaluating the safety and tolerability of 3 escalating fixed doses of vurolenatide in 9 adults with SBS for 56 days. The drug was found to be generally safe and well tolerated, and importantly, 8 of the 9 patients enrolled experienced meaningful declines in total stool output following each dose, relative to a baseline output.
Vurolenatide is patent-protected and has received orphan drug designation by the FDA.