9 Meters Biopharma Company (NASDAQ: NMTR) is a clinical biotech corporation that focuses on the unmet and rare needs in gastroenterology. The company recently announced that they were initiating Phase II of the vurolenatide trial, a proprietary glucagon-like, long-acting peptide-1 agonist in people suffering from short bowel syndrome.
9 Meters’ CEO and President, Temperato, said that initiating the trial marked an important milestone for both families and individuals affected by debilitating short bowel syndrome effects, including chronic diarrhea. He further stated that the trial would get them closer to potentially providing people with a long-acting treatment solution with fewer safety concerns and rapid onset.
This Phase II trial, also referred to as the VIBRANT study, is basically a multicenter, placebo-controlled, double-blind study of the tolerability, efficacy, and safety of vurolenatide in adults suffering from short bowel syndrome. The study is expected to be conducted on around 22 patients across seven sites in the United States. The central IRB has approved the trial study protocol, and it’ll include four parallel treatment arms: placebo, 100mg of vurolenatide every other week, 50mg of vurolenatide every other week and 50mg of vurolenatide weekly. Experts anticipate that this will be the biggest placebo-controlled Phase II trial that has been done in short bowel syndrome to date.
9 Meters’ Chief Medical Officer, Patrick Griffin, M.D., said that the study was going to be the first of its kind to showcase the potential of a development-stage short bowel syndrome therapy irrespective of gut anatomy. He further stated that vurolenatide has shown encouraging data, with patients showing improvement in their bowel frequency and stool output. The company is looking forward to showing the impact this experimental drug has on patients of post-surgical phenotypes.
This novel chemical component is an injectable long-acting GLP-1 receptor agonist which utilizes XTEN tech to extend its half-life. In addition, Vurolenatide has shown that it can improve gastric motility in several post-surgical phenotypes of short bowel syndrome patients by reducing the digestive transit time.