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.
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.