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- The vurolenatide 50 mg every other week (Q2W) dosing arm demonstrated a 30 percent reduction in the Phase 2 study’s primary endpoint over six weeks, the mean reduction in total stool output (TSO), compared to a 32 percent increase with placebo – for a mean relative reduction of 62%
- Based on the end-of-phase 2 meeting, the company plans to submit the phase 3 protocol to the FDA to finalize study design details at a dosing of 50 mg every other week
- Clinical plans and activities are underway to facilitate the start of Phase 3 upon protocol completion
RALEIGH, NC / ACCESSWIRE / September 26, 2022 / 9 Meters Biopharma, Inc. (NASDAQ: NMTR), a clinical-stage company developing breakthrough novel treatments for people living with rare or debilitating digestive diseases, today announced positive final results from the Phase 2 study of vurolenatide and the result of its end- of- Phase 2 meeting with the US Food and Drug Administration (FDA). Vurolenatide is a proprietary long-acting GLP-1 receptor agonist in development for adults with short bowel syndrome (SBS). Based on the outcome of the meeting and Phase 2 data, 9 Meters intends to complete the Phase 3 protocol in collaboration with the FDA in the fourth quarter. Clinical plans and activities are currently underway to facilitate initiation of the study upon completion of the protocol. The Company plans to provide further details on the Phase 3 clinical development program for vurolenatide upon completion of the protocol.
The Company announced the completion of its phase 2 study of vurolenatide in SBS. ELEVATED (v urolenate I en short B Owl Syndrome R independent of p A Rental support required N.T ) was a multicenter, double-blind, placebo-controlled, parallel-group study evaluating the safety, efficacy, and tolerability of vurolenatide in adult patients with SBS. The study included four parallel treatment arms: vurolenatide 50 mg every other week (Q2W), vurolenatide 50 mg every week, vurolenatide 100 mg Q2W and placebo. The primary efficacy endpoint of the study was the change from baseline in mean 24-hour TSO volume during the 6-week follow-up period after randomization.
The randomization block of the first 11 patients in the four arms resulted in three patients in each vurolenatide arm and two patients in the placebo arm. The mean 24-hour TSO decrease for the vurolenatide Q2W 50 mg arm was 30% versus an increase of 32% in the placebo arm, representing a relative decrease of 62% compared to placebo. This group showed rapid (at one week) and sustained TSO reduction over the six-week period after randomization. Importantly, in the 50 mg Q2W treatment group, a TSO reduction from baseline was observed in 16 of the 18 weeks of the observation period. These results, along with the most favorable adverse event and optimal pharmacokinetic profile, contributed to the company’s decision to move this dosing regimen into a pivotal clinical development program.
In patients treated with vurolenatide 50 mg every week, there was a mean TSO decrease of 8%, a relative decrease of 40% compared to placebo. In patients treated with vurolenatide 100 mg every two weeks (Q2W), there was a mean TSO increase of 16%, representing a 16% relative reduction compared to placebo. Notably, the pharmacokinetic profile of these two arms showed evidence of drug accumulation, resulting in a suboptimal pharmacokinetic profile.
The study allowed for the inclusion of SBS patients who both required and did not require parenteral nutritional support. Five of the 11 patients in the study received parenteral support prior to study entry and all five were randomly assigned to receive vurolenatide treatment. The change from baseline in volume of parenteral support, a key secondary endpoint, was also assessed over the 6-week observation period. There was a mean decrease of 17% in the parenteral support volume of these five patients by week two, which persisted throughout the 6-week observation period. Of the five patients, two remained stable and three had a mean PS decrease of 28%.
Of the 12 patients in the safety population, vurolenatide was generally well tolerated, with mild to moderate and transient adverse events, the most common of which were nausea and vomiting. One patient discontinued the 100 mg Q2W arm prematurely due to nausea and vomiting. Importantly, there were no serious adverse events associated with vurolenatide. Two serious adverse events were reported, but were considered unrelated to the study drug. Both were central catheter infections common in patients on central infusion.
“Results from the VIBRANT study have met our goal of reconfirming the efficacy and safety of vurolenatide and establishing the dose to be adopted into Phase 3,” said John Temperato, President and Chief Executive Officer. “Vurolenatide is the first GLP-1 agonist designed specifically for SBS and has a unique mechanism of action and clinical benefits as observed in our phase 2 study, including rapid onset of action, sustained response and convenient dosing regimen. This is us working with the FDA to finalize protocol details in Q4 and plan to start the Phase 3 study shortly thereafter.”
Patrick H. Griffin, MD, FACP, Chief Medical Officer at 9 Meters, commented, “We sincerely thank the patients, nurses, investigators and their field staff for their dedication to this study. Vurolenatide has the potential to offer important benefits for those living with SBS, including alleviating unrelenting chronic diarrhea, which can significantly impair quality of life, as well as reducing the overall need for parenteral nutrition for those who need it.
About 9 meters Biopharma
9 Meters Biopharma, Inc. is a clinical-stage company developing breakthrough novel treatments for people living with rare digestive diseases, gastrointestinal disorders with unmet needs and debilitating conditions where the biology of the gut plays a role. 9 Meters is developing Vurolenatide, a proprietary Phase 2 long-acting GLP-1 agonist for SBS; larazotide, a tight junction regulator for MIS-C; and several near-clinical stage assets.
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This press release contains forward-looking statements based on 9 Meters’ current expectations. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, projections, anticipated milestones and any other statements regarding our future activities or other future events or conditions. These statements are based on current expectations, estimates and projections about our business, some of which are based on assumptions made by management. Actual results and timing of events could differ materially from those anticipated in such forward-looking statements due to various risks and uncertainties, including, without limitation: uncertainties related to clinical development and regulatory approval of product candidates; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; risks related to our ability to successfully execute our strategic plans, including dependence on our lead product candidate; risks related to 9 Meters’ inability to raise sufficient additional capital to further advance these product candidates and its preclinical programs, also given current stock market conditions; risks associated with failure to realize value from product candidates and preclinical programs being developed and anticipated to be developed, given the inherent risks and difficulties associated with successfully bringing product candidates to market; intellectual property risks; the impact of COVID-19 on our operations, clinical trial enrollment and schedule; risks associated with the Company’s leverage by borrowing under the Credit Facility and complying with its terms; risk of delisting from Nasdaq; dependence on employees; dependence on research and development partners; risks related to cybersecurity and privacy; and risks associated with the acquisition and development of additional compounds. These and other risks and uncertainties are more fully described in periodic filings with the SEC, including the factors described in the “Risk Factors” section of 9 Meters’ Annual Report on Form 10-K for the year ended December 31, 2021 as amended or amended through our quarterly reports on Form 10-Q and in other filings that 9 Meters has filed and in future filings that 9 Meters will file with the SEC. You should not place undue reliance on these forward-looking statements, which are made only as of the date of this release or as of the dates indicated in the forward-looking statements. 9 Meters expressly disclaims any obligation or undertaking to publicly release any updates or revisions to any forward-looking statements contained herein to reflect any changes in its expectations with respect to them or any change in events, conditions or circumstances on which any such statements are based.
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