The stock price of 9 Meters Biopharma Inc. (NASDAQ: NMTR) gained 19.32% to $0.2470 as of Tuesday’s last check after the company announced favorable trial results. NMTR fell -1.43% to $0.21 at the end of the last trading session.
NMTR has announced what results?
In addition to positive final results from the Phase 2 study of vurolenatide, 9 Meters Biopharma (NMTR) also announced its end-of-phase 2 meeting results with the US Food and Drug Administration (FDA). A proprietary long-acting GLP-1 receptor agonist is being developed for adults with short bowel syndrome. The Phase 3 protocol will be finalized by 9 Meters in collaboration with the FDA during the fourth quarter based on the outcome of the meeting and the Phase 2 data.
9 Meters Biopharma plans to provide additional details on Phase 3 vurolenatide clinical development program following the protocol finalization at NMTR once it is finalized. NMTR is currently planning clinical trials and activities that will facilitate study initiation once the protocol is finalized.
Phase 2 of NMTR’s vurolenatide study in SBS has been completed. In a multicenter, double-blind, placebo-controlled, parallel-group study, VIBRANT (Vurolenat I de for short bowel syndrome Regardless of the need for parenteral support) evaluated the safety, efficacy, and tolerability of vurolenatide in adult patients with SBS.
The 50 mg Q2W treatment group saw a reduction in TSO from baseline for 16 of the 18 weeks during the observation period. As a result of these results and the optimal pharmacokinetic profile and the favorable adverse event profile, the Company decided to move forward with the clinical development of this dose regimen.
What has NMTR observed?
SBS patients who required or did not need parenteral nutrition support were included in the study by 9 Meters Biopharma (NMTR). As part of the study, five patients received parenteral support prior to entering and were assigned a random treatment with vurolenatide. A secondary endpoint of the 6-week observation period was also the change from baseline in parenteral support volume. By week two of this NMTR’s observation period, there was a mean decrease in parenteral support volume of 17% for these five patients.