9 Meters Biopharma Announces Positive Preliminary Results from Phase 2 Study of Vurolenatide in Short Bowel Syndrome
- Phase 2 VIBRANT study identifies a dose and dosing interval with >25% improvement in the primary endpoint of 24-hour mean total stool output reduction over 6 weeks
- Vurolenatide was generally well tolerated with no adverse events leading to early study withdrawal
- End-of-Phase 2 meeting with FDA scheduled for mid-third quarter
- Phase 3 study for vurolenatide could begin as early as fourth quarter 2022 pending outcome of end-of-Phase 2 meeting; Study planning and logistics well underway
RALEIGH, NC / ACCESSWIRE / June 30, 2022 / 9 Meters Biopharma, Inc. (NASDAQ:NMTR), a clinical-stage company pioneering novel treatments for people with rare or debilitating digestive diseases, today announced positive preliminary topline results from the VIBRANT study (VurolenatIde for short Bowel syndrome Regardless of pArenteral support requiremeNT), its Phase 2 trial of vurolenatide, a proprietary, long-acting GLP-1 receptor agonist in development for the treatment of adult patients with short bowel syndrome (SBS). Based on positive results from this Phase 2 study and other supportive data, an end-of-Phase 2 meeting with FDA has been scheduled for mid-third quarter.
The topline preliminary results are based on data from a complete randomization block and are intended to support an end-of-Phase 2 meeting. The study remains ongoing and blinded in order to collect additional safety data and potentially enable utilization of the complete results to support a future NDA submission.
Results are based on the first 11 randomized patients with appropriate distribution across the four arms of the ongoing study and successfully identified the most effective and tolerable dose and dosing interval intended to progress into the planned Phase 3 study. Overall, 7 of 11 patients met the primary efficacy definition of TSO responder (greater than or equal to 10% reduction from baseline in 24-hour mean TSO) over the 6-week efficacy evaluation period. The arm of the study anticipated to be taken forward into Phase 3 showed a mean reduction in TSO of greater than 25%. Parenteral support volume, a secondary endpoint, was evaluated over the 6-week treatment period. Three of the five patients in the study with a parenteral support requirement, all of whom were randomly assigned to active drug, demonstrated a mean decrease (defined as greater than or equal to 20%) in their parenteral support volume requirement over the treatment period.
Vurolenatide was generally well tolerated with mild to moderate and transient side effects including nausea and vomiting, which are typical for GLP-1 agonists. There were no adverse events leading to early study withdrawal. Two serious adverse events were reported, which were deemed to be unrelated to study drug; both were central catheter infections, which are common in patients with a central line. Overall results from the study support and build upon the findings from 9 Meters' prior Phase 1b/2a trial of vurolenatide in SBS.
"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. 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," said Patrick H. Griffin, M.D., FACP, Chief Medical Officer at 9 Meters. "The Phase 2 study findings are supportive of the efficacy and safety of vurolenatide and will serve as the basis for our end-of-Phase 2 meeting. Further details of the study will be made available at a later date given the study is ongoing and remains blinded pending our discussion with FDA and our plan to ensure the trial meets the adequate and well-controlled standard."
John Temperato, President and Chief Executive Officer of 9 Meters, commented, "I am very pleased with the progress we are making with vurolenatide in our mission to provide novel treatments for those suffering from debilitating digestive diseases in just over two years since the company's inception. Based on the product profile and clinical data to date, we believe vurolenatide has the potential to play a critical role in the first-line treatment of patients with short bowel syndrome, as many patients are not candidates for the current standard of care, GLP-2 therapy."
The Company plans to communicate additional details from the study as well as plans for the Phase 3 trial following the end-of-Phase 2 meeting with FDA that is set for mid-third quarter. The Company currently anticipates initiating the VIBRANT-2 Phase 3 study as early as the fourth quarter of 2022. Plans for the study, including site identification and recruitment, are well underway.