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

Patrick H. Griffin, M.D., Chief Medical Officer of 9 Meters, added, "The VIBRANT study is positioned to be the first to show the treatment potential of an investigational SBS therapy regardless of gut anatomy or the extent of parenteral support requirement. Vurolenatide has shown positive data to date, with patient improvement in total stool output and bowel frequency. We look forward to demonstrating the candidate's impact on patients of all post-surgical phenotypes."

Vurolenatide was previously evaluated in an open-label, two-dose Phase 1b/2a clinical trial evaluating the safety and tolerability of three 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.

About Vurolenatide (formerly NM-002)

Vurolenatide, a novel chemical entity, is a long-acting injectable GLP-1 receptor agonist that utilizes proprietary XTEN® technology to extend its circulating half-life. Vurolenatide has been shown to improve gastric motility in multiple post-surgical phenotypes of SBS patients by slowing digestive transit time. This mechanism is intended to improve intestinal absorption of nutrients and water and reduce diarrhea for all patients regardless of parenteral support requirements. In late 2020, 9 Meters announced positive topline data from its Phase 1b/2a study in adult SBS patients, and 9 Meters initiated the largest placebo-controlled Phase 2 trial in SBS in an ambulatory setting in Q2 2021, which includes patients with all post-surgical phenotypes of SBS regardless of their parenteral support requirements. An FDA meeting communication conducted in Q1 2021 supports utilizing total stool output (TSO) as the primary efficacy outcome measure in the Company's planned vurolenatide Phase 2 study.

About Short Bowel Syndrome

According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), SBS is a rare syndrome related to poor absorption of nutrients due to at least half of the small intestine, and sometimes all or part of the large intestine, being removed; significant damage to the small intestine; or poor motility, or movement inside of the intestines. The incidence of SBS is not precisely known but is estimated at about 5 to 10 patients per million people per year. In adults, the incidence of SBS requiring at-home parenteral nutrition is estimated at two adult patients per million people per year. Pharmacologic therapies for SBS include trophic factors, such as short-acting daily injectable GLP-2 analogues, which may not be appropriate for all patient types.