RALEIGH — 9 Meters Biopharma, a clinical-stage rare gastroenterology company headquartered in Raleigh, has begun dosing the first patients of its Phase 1b/2a clinical trial to assess NM-002 in adults with short bowel syndrome (SBS), it announced this week.
SBS is a life-threatening orphan disease caused by a significant shortening of the gastrointestinal tract, leading to impaired nutrient absorption. Many SBS patients rely at least partly on parenteral support, an intravenous method of providing hydration, essential nutrients and electrolytes.
9 Meters’ treatment, NM-002, is a long-acting injectable glucagon-like peptide-1 (GLP-1) receptor agonist designed specifically to treat gastric motility in SBS patients by slowing digestive transit time.
Its CEO and president John Temperato contends it may reduce reliance on parenteral support.
“9 Meters seeks to offer a therapeutic option for SBS patients that mitigates reliance on parenteral support, and minimizes the frequency of dosing for patients,” he said in a statement. “When a shortened GI tract is incapable of absorbing sufficient nutrients and fluids, parenteral support is a life-saving measure. However, intravenous supplementation is extremely burdensome and can increase the risk of injection-site infection or kidney or liver complications. We hope that NM-002 can improve these patients’ quality of life.”
9 Meters is the product of the newly merged Raleigh-based Innovate Biopharmaceuticals, a clinical stage biotechnology company focused on developing novel therapeutics for autoimmune and inflammatory diseases and Israeli-based RDD Pharma, a startup focused on orphan and innovative therapies for gastrointestinal disorders.
Competed in May, the company also raised $22 million in new financing led by Orbimed Advisors, LLC, and the signing of the previously announced merger with Naia Rare Diseases, a company developing a proprietary long acting GLP-1 for the treatment of Short Bowel Syndrome.
Named after the approximate length of the digestive track, 9 Meters focuses on specialty, rare and orphan gastrointestinal diseases.
9 Meters said the Phase 1b/2a clinical trial is an open-label, single-center study evaluating the safety and tolerability of three escalating doses of NM-002 in adult patients with SBS. Patients in each of three cohorts will receive two doses of NM-002 two weeks apart. Change in daily urine output volume is designated as the primary endpoint, as an inversely related proxy for usage of parenteral support.
NM-002 has been granted Orphan Designation by the U.S. Food and Drug Administration.
The trial is taking place at Cedars-Sinai in Los Angeles, with results expected in the first half of 2021.
It is also working on the receipt of top-line results for an ongoing Phase 3 trial in celiac disease in 2021.