9 Meters Biopharma (NASDAQ:NMTR) said its medicine vurolenatide met the main goal of reducing 24-hour total stool output (TSO) volume in seven out of 11 patients with short bowel syndrome in a phase 2 trial.
Based on preliminary data from the mid stage study, dubbed VIBRANT, the company has scheduled a end-of-phase 2 meeting with the FDA for mid-third quarter.
The company added that it has chosen a dose and dosing interval for a potential phase 3 trial.
The company said the study is ongoing as the data was from 11 randomized patients across four groups.
Over the 6-week efficacy evaluation period, seven out of 11 patients met the main efficacy goal of improvement in TSO volume (greater than or equal to 10% reduction from baseline in 24-hour average TSO), according to a June 30 press release.
The company added that the group expected to be taken forward into phase 3 showed an average reduction in TSO of greater than 25%
Three out of five patients with a parenteral support requirement, showed an average decrease (defined as greater than or equal to 20%) in their parenteral support volume, a secondary goal of the study.
The company added thta vurolenatide was generally well tolerated with mild to moderate and transient side effects.
NMTR -9.72% to $0.30 premarket June 30