Lael Yonker, MD
Image credit: Mass General Brigham
A small study found the larazotide—an experimental drug originally developed to treat Celiac disease—was both safe and effective in treating children with MIS-C. The results were published in the journal, Science Translational Medicine. 1
“Children treated with larazotide displayed faster resolution of gastrointestinal symptoms, faster clearance of spike antigen, and a faster return to usual activities,” the investigators wrote.2
“Our findings suggest that larazotide is safe and quickly resolves symptoms in children with MIS-C,” lead author Lael Yonker, MD, co-director of the Cystic Fibrosis Center, Cystic Fibrosis Therapeutic Development Center, and Pulmonary Genetics Clinic at Mass General Brigham for Children, said in a statement. 1
Current MIS-C treatments are limited. Some patients receive general anti-inflammatory drugs, but many experience a rebound of symptoms after completing a course. Such drugs are not designed to target the sticky SARS-CoV-2 viral particles that may persist in the gut.1 Larazotide, an orally administered drug targets the gut. Larazotide is late-stage, investigational, oral therapy that is a novel, synthetic, eight-amino acid peptide that antagonizes zonulin, a key tight junction protein implicated in celiac disease pathogenesis.3 Larazotide strengthens intestinal barriers to limit the number of materials—like SARS-CoV-2 viral particles—that exit the intestines and enter circulation.1
Study Specifics
The investigators conducted a double-blind clinical trial with 12 children experiencing early-stage MIS-C. The study was funded in part by the National Institutes of Health. Children were enrolled during hospitalization for acute MISC. The media age for the participants was 5.7 years.2
Each patient randomly received either a placebo or larazotide 4 times daily for 21 days, then was tracked over 6 months of recovery. No larazotide-related adverse events were reported according to the investigators. The findings demonstrate larazotide may be a safe and promising treatment option for children with MIS-C.1
MIS-C is a rare but serious condition associated with COVID-19, which can cause internal and external parts of the body to become inflamed. 4 The number of cases reported decreased from 2020 to 2023 and it affects younger children compared to older adolescents.4
Yonker and her colleagues are going to see if this treatment may be applicable to another COVID-19 long-term issue. “We are now running a clinical trial to test whether larazotide may also be a useful therapy to treat patients with Long COVID.”1