Long-acting injectable GLP-1 analogue for short bowel syndrome (SBS)
Vurolenatide is designed specifically to address the gastric effects in SBS patients by slowing digestive transit time. With an extended half-life, the GLP-1 receptor analogue peptide, allows for twice- to potentially once-per-month dosing, thus considerably increasing convenience for patients and caregivers. Vurolenatide is patent-protected and has received orphan drug designation by the FDA. The company announced positive topline phase 1b/2a data in adult patients suffering from SBS and is continuing to develop the compound for this high unmet need.
About short bowel syndrome (SBS)
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 not precisely known but is estimated at about 5 to 10 patients per million people per year. In adults, the incidence of SBS requiring at-home parenteral nutrition is estimated at two adult patients per million people per year. 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.
Orally administered, gut-restricted tight-junction regulator for celiac disease
Larazotide represents the only Phase 3 therapeutic in development for celiac disease, with data readouts expected in 2022. Larazotide prevents the gluten breakdown product gliadin from entering into the 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.
About Celiac disease
Celiac disease is an autoimmune 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 breaks down into gliadin, which disrupts tight junctions between cells in the gut in people with celiac disease. These disruptions cause gliadin to enter the systemic circulation and stimulate 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. NM-003 is patent protected and expected to enter an IND-enabling pathway in 2021.
Small molecule tight junction microbiome modulator
NM-102 is being developed as a potential microbiome modulator and undergoing an indication selection process. NM-102 is expected to enter an IND-enabling pathway in 2021.
Small molecule immunomodulator
NM-004 is also undergoing a portfolio rationalization and indication selection process. NM-004 is patent protected and has orphan designation for pediatric UC with an expectation for an indication selection to complete in the first half of 2021.