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
This press release includes forward-looking statements based upon the Company's current expectations. Forward-looking statements involve risks and uncertainties, and include, but are not limited to, the potential effects of the ongoing coronavirus outbreak and related mitigation efforts on the Company's clinical, financial and operational activities; the Company's continued listing on Nasdaq; expectations regarding future financings; the future operations of the Company; the nature, strategy and focus of the Company; the development and commercial potential and potential benefits of any product candidates of the Company; anticipated preclinical and clinical drug development activities and related timelines, including the expected timing for data and other clinical and preclinical results; the Company having sufficient resources to advance its pipeline; and any other statements that are not historical fact. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: (i) uncertainties associated with the clinical development and regulatory approval of product candidates; (ii) risks related to the inability of the Company to obtain sufficient additional capital to continue to advance these product candidates and its preclinical programs; (iii) uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; (iv) risks related to the failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; (v) the impact of COVID-19 on our operations, clinical trials or proposed merger and future financings and (vi) risks associated with the possible failure to realize certain anticipated benefits of the Company's recent merger and the