9 Meters BioPharma
Pioneering Novel Treatments for Digestive Diseases
According to the Celiac Disease Foundation, the incidence of celiac disease has been rising since the second half of the 20th century into the 21st century in nearly every country where data on the disease are available. Today, more than 3 million people in the U.S. suffer from celiac disease, which makes more common than ulcerative colitis, Crohn’s disease and rheumatoid arthritis. Unfortunately, the only current treatment for celiac is a gluten free diet.
9 Meters is a development stage biopharmaceutical company that focuses on rare and unmet needs in digestive diseases and unique GastroIntestinal (GI) biology. They are leading the way with therapeutic approaches that treat people with rare and debilitating conditions by leveraging the biology of the gut and its influence on a myriad of conditions.
9 Meters’ initial focus is on creating innovative treatments for celiac disease and short bowel syndrome (sbs), a rare, orphan disease in which your body is unable to absorb enough nutrients from the foods you eat because you don’t have enough small intestine.
Their lead candidate, Lazarotide, is the first drug to move into a Phase 3 trial in celiac. The study will be completed in 2022 and has been given fast-track designation by the FDA. Lazarotide is a tight junction regulator that works by improving intestinal epithelial barrier integrity, which the gliadin peptides in gluten break down. I
9 Meters has also developed Vorunlenatide for the treatment of short bowel syndrome which affects about 20,000 people in the U.S. People with short bowel syndrome cannot absorb enough water, vitamins, minerals, protein, fat, calories, and other nutrients from food. Some children are born with an abnormally short intestine, while others suffer from short bowel syndrome after having some of their intestine surgically removed.
Patients with abs have a compromised level of GLP-1, a naturally occurring peptide produced in a portion of the ileum that is removed during surgical resection. GLP-1 prevents the GI tract from moving rapidly and is known as the “ileal brake.” Without this brake, there is a lack of gut motility, causing an SBS patient’s remaining bowels to empty rapidly and frequently impeding the ability to absorb nutrients. Vorunlenatide is a long-lasting GLP-1 that slows gut motility, which increases the time for absorption of nutrients in the small intestine.
In Phase 1b/2a trials, Vorunlenatide began acting within hours of dosing and was efficacious in reducing stool output and diarrhea, and overall improvements in general wellbeing. A full phase 2 study was initiated in Q2 of 2021 with topline results expected in Q4.
9 Meters has four other projects in its pipeline and has initiated an IND-enabling pathway for each. For more information on the company, visit 9meters.com.
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