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The majority of patients in the phase 2 study met the primary efficacy endpoint of a greater than or equal to a 10% reduction in total stool output over the 6-week efficacy evaluation period.
New phase 2 data shows vurolenatide could be an effective agent in treating short bowel syndrome (SBS).
The data, announced by 9 Meters Biopharma, comes from preliminary topline results of the VIBRANT study (VurolenatIde for short Bowel syndrome Regardless of pArenteral support requiremeNT), a multicenter, double-blind, placebo-controlled parallel group study testing the safety, efficacy, and tolerability of the proprietary, long-acting GLP-1 receptor agonist.
The trial included 4 parallel treatments arms of vurolenatide 50 mg weekly, 50 mg every other week, vurolenatide 100 mg every other week, and placebo.
The results are based on the complete randomization block, with the study ongoing and blinded to collect additional safety data and potentially enable the use of the complete data to support a New Drug Application (NDA) in the future.
The data is from 11 randomized patients with appropriate distribution across 4 different arms of the VIBRANT study. The investigators believe they have identified the most effective and tolerable dose and dosing interval to further test in the planned phase 3 trial.
In the preliminary results, 7 participants met the primary efficacy definition of total stool output (TSO) responder of greater than or equal to a 10% reduction from baseline in a 24 hour span over the 6-week efficacy evaluation period.
The investigators anticipate a mean reduction in TSO of greater than 25% taken into the upcoming phase 3 trial.
The team also sought a secondary endpoint of parenteral support volume over the 6-week treatment period and found 3 of the 5 patients in the study with a parenteral support requirement showed a mean decrease of greater than or equal to 20% in their parenteral support volume after being randomly assigned to the active drug.
For safety, vurolenatide was well-tolerated, without only mild to moderate and transient side effects identified. This included nausea and vomiting, which are typical side effects for GLP-1 agonists. Overall, there were no adverse events that led to an early withdrawal from the study.
There were a pair of serious adverse events found, which the investigators did not relate to vurolenatide as they were both central catheter infections, common in patients with a central line.
The company has scheduled an end-of-Phase 2 meeting with the US Food and Drug Administration in the coming months.
"Given the severity and life-threatening nature of SBS, as well as the significant impact on quality of life, we are very pleased to have identified a vurolenatide dose and dosing interval to progress into Phase 3 development,” Patrick H. Griffin, MD, FACP, Chief Medical Officer at 9 Meters, said in a statement. “Vurolenatide may offer a novel and alternative approach to treating appropriate individuals with SBS as it has been shown to decrease total stool output and reduce parenteral support needs which are critical to the health and well-being of individuals with short bowel syndrome."