- Study in adult short bowel syndrome (SBS) patients initiated in June 2020
- NM-002 is a long-acting GLP-1 agonist designed to address the gastric effects in SBS patients by slowing digestive transit time
- First patient expected to be dosed in July 2020
RALEIGH, NC / ACCESSWIRE / June 24, 2020 / 9 Meters Biopharma, Inc. (NASDAQ:NMTR), a clinical-stage rare and unmet needs-focused gastroenterology company, today announced it has initiated its Phase 1b/2a clinical trial of NM-002 for the treatment of short bowel syndrome (SBS), a life-threatening orphan disease caused by a significant shortening of the gastrointestinal tract, leading to impaired nutrient absorption. NM-002 is a long-acting injectable glucagon-like peptide-1 (GLP-1) agonist designed specifically to exploit gut motility effects in SBS patients by slowing digestive transit time.
The Phase 1b/2a clinical trial of NM-002 is an open-label, single-center study evaluating the safety and tolerability of three escalating doses of NM-002 in adult patients with SBS. The three different dosing cohorts will each receive two doses of NM-002 two weeks apart, with daily urine output as a primary endpoint, an inversely related proxy for usage of parenteral support. Parental support is a current treatment option used to intravenously provide SBS patients with hydration, essential nutrients and electrolytes. NM-002 has demonstrated safety with an extended half-life of up to 30 days in a 70-patient clinical study and has received Orphan Designation by the U.S. Food and Drug Administration.
"Advancing NM-002 into our Phase 1b/2a trial is a major milestone for 9 Meters as we strive to create a more effective treatment option for patients with SBS," said John Temperato, president and chief executive officer of 9 Meters. "Not only is SBS a life-threatening disease when untreated, but the current treatment standard of parenteral support is insufficient, as it results in an extremely low quality of life for patients. We look forward to developing NM-002 to reduce reliance on intravenous supplementation, and therefore give patients the freedom to live a less restricted lifestyle and reduce their financial burden."
"In developing NM-002, we've used Amunix's proprietary XTEN® technology to extend the half-life of the GLP-1 peptide, which allows the drug to be injected only once or twice per month. This considerably increases convenience for patients and caregivers compared to other GLP-2 drug products on the market for SBS which must be dosed daily," said Patrick H. Griffin, M.D., FACP, chief medical officer of 9 Meters.
The trial will take place at Cedars-Sinai in Los Angeles. The first patient is expected to be dosed in this Phase 1b/2a trial in July 2020, with topline results expected in the first half of 2021. For more information on the trial, please visit ClinicalTrials.gov: NCT04379856.
The patent rights covering the use of the GLP-1 agonist technology to treat short bowel syndrome are owned by Cedars-Sinai Medical Center and are exclusively licensed by Cedars-Sinai to Naia Rare Diseases, a wholly-owned subsidiary of the 9 Meters Biopharma, Inc.
About Short Bowel Syndrome
According to the National Institute of Diabetes, and Digestive and Kidney Diseases (NIDDK), SBS is a rare syndrome of problems related to poor absorption of nutrients as a result of at least half of the small intestine being removed and sometimes all or part of the large intestine; significant damage to the small intestine; or poor motility, or movement inside of the intestines. The incidence of SBS is poorly known but estimated at about 5 to 10 patients per year per million population. In adults, the incidence of SBS requiring at-home parenteral nutrition is estimated at two adult patients per year per million population. Pharmacologic therapies for SBS include trophic factors, such as short-acting daily injectable GLP-2 analogues, which may not be appropriate for all patient types.
About 9 Meters Biopharma
9 Meters Biopharma, Inc. is a rare and unmet needs-focused GI company. The Company is advancing NM-002, a proprietary long-acting GLP-1 agonist into a Phase 1b/2a trial for Short Bowel Syndrome (SBS), an orphan designated disease, as well as larazotide, a Phase 3 tight junction regulator being evaluated for celiac disease.
For more information, please visit www.9meters.com.
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LifeSci Communications, LLC
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LifeSci Advisors, LLC
SOURCE: 9 Meters Biopharma, Inc.