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celiac disease

What is Celiac Disease?

Celiac disease is an autoimmune gastrointestinal 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 it 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 enable gliadin to enter systemic circulation and stimulate an inflammatory response.

Check out our Celiac Disease clinical trial

Larazotide

Orally administered, gut-restricted tight-junction regulator for celiac disease

Larazotide is the only Phase 3 therapeutic in development for celiac disease, with data readouts expected in 2022. Larazotide is designed to mitigate the life-altering symptoms that people with celiac disease may experience when they ingest gluten. Specifically, larazotide prevents gluten breakdown product, gliadin, from entering the systemic circulation through compromised tight junctions between intestinal cells that occur in celiac disease, and in turn propagating an inflammatory response in the gut. 9 Meters aims to introduce larazotide as an adjunctive therapy in tandem with a gluten-free diet in adults with celiac disease to restore tight junctions between intestinal cells, mitigate gliadin "leakage," and thus minimize symptoms.

short bowel syndrome (sbs)

What is SBS?

According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), SBS is a rare syndrome 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 2 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.

Vurolenatide

Long-acting injectable GLP-1 analogue for short bowel syndrome (SBS)

Vurolenatide is designed specifically to slow digestive transit, thereby mitigating the SBS hallmark of excessive gastric motility due to deficient GLP-1 in the shortened intestine. This mechanism is intended to improve intestinal absorption of nutrients and water and reduce diarrhea for all patients with any type of post-surgical SBS, regardless of their parenteral support requirements. Owing to its extended half-life, vurolenatide only needs to be dosed twice monthly at most, thus considerably improving convenience for patients and their caregivers.

9 Meters initiated VIBRANT, the largest placebo-controlled Phase 2 trial in SBS in an ambulatory setting, in Q2 2021, which includes patients with all post-surgical types of SBS regardless of their parenteral support requirements. An FDA meeting communication supported utilizing total stool output (TSO) as the trial’s primary efficacy outcome measure. A Phase 3 trial is expected to begin by the end of 2021.

Previously, the company announced positive topline data from an open-label, 2-dose Phase 1b/2a data in adults with SBS evaluating the safety and tolerability of 3 escalating fixed doses of vurolenatide in 9 adults with SBS for 56 days. The drug was found to be generally safe and well tolerated, and importantly, 8 of the 9 patients enrolled experienced meaningful declines in total stool output following each dose, relative to a baseline output.

Vurolenatide is patent-protected and has received orphan drug designation by the FDA.

development programs

NM-003

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.

NM-102

Small molecule tight junction microbiome modulator

NM-102 is being developed as a potential microbiome modulator and is undergoing an indication selection process. NM-102 is a long-acting, degradation-resistant peptide, believed to be gut-restricted, and presumed to prevent gut microbial metabolites and antigens from trafficking into systemic circulation. NM-102 was effective alone or when combined with immune checkpoint inhibitors (ICIs) in a pre-clinical transgenic mouse model of spontaneous aggressive skin melanoma. Furthermore, the combination of NM-102 with ICIs improved survival compared to ICIs alone. NM-102 is expected to enter an IND-enabling pathway in 2021.

NM-136

Long-acting, highly specific humanized anti-GIP monoclonal antibody for Prader-Willi Syndrome (PWS)

NM-136, formerly known as LOB-0136, targets glucose-dependent insulinotropic polypeptide (GIP), a hormone found in the upper small intestine that is released into circulation after food is ingested, and when found in high concentrations, can contribute to obesity and obesity-related disorders like Prader-Willi Syndrome (PWS). NM-136 has been shown to prevent GIP from binding to its receptor, which in preclinical obesity models has been shown to significantly decrease weight and abdominal fat by reducing nutrient absorption from the intestine as well as nutrient storage without affecting appetite. 9 Meters aims to continue the manufacturing and IND-enabling studies of NM-136 and intends to conduct a proof-of-concept study in PWS in 2023.

NM-004

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 ulcerative colitis with an expectation for an indication selection in 2021.

enhancing our capabilities with strategic partnerships

9 Meters has worked to build partnerships with key GI disease and patient advocacy groups to ensure we are working to make the biggest difference.

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