Long-acting injectable GLP-1 analogue for short bowel syndrome (SBS).
NM-002 is designed specifically to address the gastric effects in SBS patients by slowing digestive transit time. Licensed from Amunix Pharmaceuticals Inc, NM-002 uses Amunix’s proprietary XTEN® technology to extend the half-life of the GLP-1 peptide, allowing for once- to twice-per-month dosing, thus considerably increasing convenience for patients and caregivers. NM-002 is patent-protected and has received orphan drug designation by the FDA. The company is on track to start a phase 1b//2a study in 2020 in adult patients suffering from SBS.
Short bowel syndrome (SBS)
Short Bowel Syndrome (SBS) is a life-altering, life-threatening orphan disease caused by a significant shortening of the gastrointestinal (GI) tract. It leads to impaired nutrient absorption, diarrhea and metabolic complications. The causes are varied but the results are very serious: the shortened GI tract needs to properly absorb nutrients, which leads to reliance on total parenteral nutrition (TPN) ) to manage their nutritional needs. TPN involves intravenous infusion for up to several hours every day which, aside from the negative impact on quality of life, carries side effects as well as high risk of systemic infections.
Orally administered, gut-restricted tight-junction regulator for celiac disease
Larazotide represents the only Phase 3-stage therapeutic in development for celiac disease, with interim analysis expected in the second half of 2021. A peptide that normalizes the disrupted tight junctions between cells in the gut seen in celiac disease patients, larazotide prevents the gluten breakdown product gliadin from entering systemic circulation and propagating an inflammatory response. 9 Meters aims to introduce larazotide as an adjunctive therapy in celiac disease to restore physiology and thus minimize symptoms in tandem with a gluten-free diet.
Celiac disease is an autoimmune functional GI disease characterized by an inflammatory response to dietary gluten, causing abdominal pain and gas that are often severe and life-altering. Adherence to a gluten-free diet is currently the only therapeutic option for people living with celiac disease and is insufficient for asymptomatic living in many cases. At a metabolic level, dietary gluten breakdown yields a product called gliadin, which disrupts adhesions called tight junctions between cells in the gut in people with celiac disease. These disruptions cause gliadin to enter systemic circulating, stimulating an inflammatory response.
Long-acting GLP-2 analogue, under orphan indication selection
NM-003 is being developed as a long-acting GLP-2 agonist undergoing a portfolio rationalization and indication selection process. Using this approach we expect the concentrations of NM-003 needed to be lower and safer than other GLP-2 approaches on the market and in development, while providing the added convenience of twice a month (instead of daily or weekly) administration. NM-003 is patent protected.
Immunomodulator, granted pediatric orphan designation in ulcerative colitis
NM-004 is also undergoing a portfolio rationalization and indication selection process. The drug is a novel oral small molecule therapeutic studies in ulcerative colitis (UC), a type of Inflammatory Bowel Disease (IBD) with no known cure. High failure rates of mesalamine treatments and few alternatives earlier in the disease course, other than steroids, could progress patients to anti-TNF biologics (AbbVie’s HUMIRA® and J&J’s REMICADE®). With the combination of an immunomodulator (approved since 1994), NM-004 could lead to a more efficacious drug than mesalamine formations alone. NM-003 is patent protected and has orphan designation for pediatric UC.