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9 Meters Biopharma, Inc. Doses the First Patients in Phase 1b/2a Clinical Trial in Short Bowel Syndrome
NM-002 is a long-acting GLP-1 agonist designed to address the gastric effects in SBS patients by slowing digestive transit time
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. 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, which may reduce reliance on parenteral support.
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,which utilizes Amunix's proprietary XTEN® technology to extend the circulating half-life of the GLP-1 peptide (exenatide) has demonstrated acceptable safety and a half-life of up to 30 days in a 70-patient clinical study and has been granted Orphan Designation by the
"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," said
"NM-002 has been designed specifically to slow gut motility to allow more time for nutrient and fluid absorption. We believe NM-002 offers several advantages over the current GLP-2 product approved for SBS, with a potentially faster onset of action and a longer circulating half-life that should allow once- or twice-monthly dosing rather than the current standard of daily injections," said
The trial is taking place at Cedars-Sinai in
The patent rights covering the use of the GLP-1 agonist technology to treat short bowel syndrome are owned by
About Short Bowel Syndrome
According to the
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